Skip to content
2000
Volume 26, Issue 1
  • ISSN: 1568-0266
  • E-ISSN: 1873-4294

Abstract

Pharmaceutical research and development encompass a series of interconnected steps that are crucial for creating safe and effective drug candidates targeting specific diseases. This process involves rigorous testing and evaluation to ensure that the drugs developed meet safety standards and therapeutic efficacy. The significance of this systematic approach lies in its ability to address the complications of various diseases, ultimately leading to advancements in medical treatment and patient care. The successful development of a drug candidate is contingent upon thorough research, which includes preclinical studies and clinical trials, ensuring that the final product is both reliable and beneficial for patients. The review emphasizes the importance of a systematic approach in the pharmaceutical research and development sector. It highlights the interconnected steps necessary for the successful development of drugs, underscoring the critical need for safety and efficacy in pharmaceutical products. The primary objective is to ensure that the drugs developed meet the standards required for public use, thereby enhancing public health outcomes. Overall, the review serves as a guide for stakeholders in the pharmaceutical industry to prioritize safety and effectiveness throughout the drug development process. With an emphasis on the interrelated processes in the drug development process and the significance of new and advanced approaches, this article highlights the evidence based on the importance of a systematic and structured approach in drug development. It points out that a systematic approach is crucial in pharmaceutical Research and Development (R&D) to ensure successful outcomes. It is essential to continuously update and understand these steps to keep pace with advancements in the field. Additionally, staying informed about the development of new and advanced techniques at each stage of drug R&D is vital for enhancing efficiency and effectiveness. This comprehensive literature review was conducted using databases such as PubMed and Scopus, focusing on research published up to January 2025. Continuous upgrades in awareness about R&D and innovative procedures within the industry are essential. It highlights the importance of following systematic methods to ensure that R&D practices remain relevant and practical. Moreover, this understanding is necessary for the safe and effective creation of pharmaceuticals. Ultimately, enhancing this awareness is likely to improve the overall effectiveness of R&D processes.

© 2026 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/ctmc/10.2174/0115680266397266250725101317
2025-08-01
2026-03-04

  • From This Site

    /content/journals/ctmc/10.2174/0115680266397266250725101317
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. BarrenhoE. MiraldoM. SmithP.C. Does global drug innovation correspond to burden of disease? The neglected diseases in developed and developing countries.Health Econ.201928112314310.1002/hec.383330417950
     [Google Scholar]
  2. JungY.L. HwangJ. YooH.S. Disease burden metrics and the innovations of leading pharmaceutical companies: A global and regional comparative study.Global. Health20201618010.1186/s12992‑020‑00610‑232912258
     [Google Scholar]
  3. The Future of Drug Safety: Promoting and protecting the health of the public.Washington, DCNational Academy Press2007
     [Google Scholar]
  4. Pharmaceutical Research and Manufacturers of America.Washington, DC2009
     [Google Scholar]
  5. KhannaI. Drug discovery in pharmaceutical industry: Productivity challenges and trends.Drug Discov. Today20121719-201088110210.1016/j.drudis.2012.05.00722627006
     [Google Scholar]
  6. PetrovaE. Innovation in the pharmaceutical industry: The process of drug discovery and development.Innovation and Marketing in the Pharmaceutical Industry: Emerging Practices, Research, and Policies;Springer New York: New York, NY20131981
     [Google Scholar]
  7. AminabeeS. The future of healthcare and patient-centric care: Digital innovations, trends, and predictions.Emerging Technologies for Health. Literacy and Medical Practice.IGI Global202424026210.4018/979‑8‑3693‑1214‑8.ch012
     [Google Scholar]
  8. SinghB. KaunertC. Blockchain framework for precision medicine, clinical trials, and genomic biomarkers discovery: Focuses on monitoring and managing data in health dimensions.AI Technologies and Advancements for Psychological Well-Being and Healthcare.Hershey, Pennsylvania, USAIGI Global2025255288
     [Google Scholar]
  9. TormayP. Big data in pharmaceutical R&D: Creating a sustainable R&D engine.Pharmaceut. Med.2015292879210.1007/s40290‑015‑0090‑x25878506
     [Google Scholar]
  10. LindsayM.A. Target discovery.Nat. Rev. Drug Discov.200321083183810.1038/nrd120214526386
     [Google Scholar]
  11. NwokikeJ. Regulatory reliance and post-marketing surveillance systems for safe and accelerated introduction of new medical products in low-and middle-income countries.Thesis, Doctoral dissertation, University of Plymouth2023
     [Google Scholar]
  12. KepplingerE.E. FDA’s expedited approval mechanisms for new drug products.Biotechnol. Law Rep.2015341153710.1089/blr.2015.999925713472
     [Google Scholar]
  13. MoneerO. BrownB.L. AvornJ. DarrowJ.J. Mitra-MajumdarM. JoyceK.W. RossM. PhamC. KesselheimA.S. New drug postmarketing requirements and commitments in the US: A systematic review of the evidence.Drug Saf.202245430531810.1007/s40264‑022‑01152‑935182362
     [Google Scholar]
  14. RavinaE. The evolution of drug discovery: From traditional medicines to modern drugs2011
     [Google Scholar]
  15. NiaziS.K. MariamZ. Computer-aided drug design and drug discovery: A prospective analysis.Pharmaceuticals20231712210.3390/ph1701002238256856
     [Google Scholar]
  16. NascimentoI.J.S. de AquinoT.M. da Silva-JúniorE.F. The new era of drug discovery: The power of computer-aided drug design (CADD).Lett. Drug Des. Discov.2022191195195510.2174/1570180819666220405225817
     [Google Scholar]
  17. dos Santos NascimentoI. J. de MouraR. O. Ligand and structure-based drug design (LBDD and SBDD): Promising approaches to discover new drugs.Applied Computer-Aided Drug Design: Models and Methods202313210.2174/9789815179934123010003
     [Google Scholar]
  18. AndricopuloA. GuidoR. OlivaG. Virtual screening and its integration with modern drug design technologies.Curr. Med. Chem.2008151374610.2174/09298670878333068318220761
     [Google Scholar]
  19. SadybekovA.V. KatritchV. Computational approaches streamlining drug discovery.Nature2023616795867368510.1038/s41586‑023‑05905‑z37100941
     [Google Scholar]
  20. RehmanA.U. LiM. WuB. AliY. RasheedS. ShaheenS. LiuX. LuoR. ZhangJ. Role of artificial intelligence in revolutionizing drug discovery.Fundamental Research2025531273128710.1016/j.fmre.2024.04.021
     [Google Scholar]
  21. SilvermanR.B. HolladayM.W. The organic chemistry of drug design and drug action.Academic press2014
     [Google Scholar]
  22. SiddiquiB. YadavC.S. AkilM. FaiyyazM. KhanA.R. AhmadN. HassanF. AzadM.I. OwaisM. NasibullahM. AzadI. Artificial intelligence in computer-aided drug design (CADD) tools for the finding of potent biologically active small molecules: traditional to modern approach.Comb. Chem. High Throughput Screen.202528Advance online publication10.2174/011386207333406224101504334339819404
     [Google Scholar]
  23. PatrickG. Organic chemistry: A very short introduction.Oxford University Press201710.1093/actrade/9780198759775.001.0001
     [Google Scholar]
  24. DeviP.S. RinuP.X. AnilkumarG. Nucleophilic addition and substitution reactions in‐water.Organic Transformations in Water.: Principles and Applications; Wiley‐VCH GmbH202523124910.1002/9783527846849.ch12
     [Google Scholar]
  25. JabbarS.S. The importance of retrosynthesis in organic synthesis.Lond J. Res. Sci. Nat. Formal20242475176
     [Google Scholar]
  26. SheldonR.A. Metrics of green chemistry and sustainability: Past, present, and future201861324810.1021/acssuschemeng.7b03505
     [Google Scholar]
  27. GopiC. KrupamaiG. SriC.S. DhanarajuM.D. An overview of recent progress in modern synthetic approach—combinatorial synthesis.Beni. Suef Univ. J. Basic Appl. Sci.20209137
     [Google Scholar]
  28. FarinaV. ReevesJ.T. SenanayakeC.H. SongJ.J. Asymmetric synthesis of active pharmaceutical ingredients.Chem. Rev.200610672734279310.1021/cr040700c16836298
     [Google Scholar]
  29. TrojanowiczM. Flow chemistry in contemporary chemical sciences: A real variety of its applications.Molecules2020256143410.3390/molecules2506143432245225
     [Google Scholar]
  30. TestaB. KrämerS.D. The biochemistry of drug metabolism--an introduction: part 4. Reactions of conjugation and their enzymes.Chem. Biodivers.20085112171233610.1002/cbdv.20089019919035562
     [Google Scholar]
  31. TestaB. KrämerS.D. The biochemistry of drug metabolism--an introduction: Part 2. Redox reactions and their enzymes.Chem. Biodivers.20074325740510.1002/cbdv.20079003217372942
     [Google Scholar]
  32. CargillJ. LeblM. New methods in combinatorial chemistry — robotics and parallel synthesis.Curr. Opin. Chem. Biol.199711677110.1016/S1367‑5931(97)80110‑X9667840
     [Google Scholar]
  33. MitscherL.A. DuttaA. Combinatorial chemistry and multiple parallel synthesis.Burg Med. Chem. Drug Disc20032135
     [Google Scholar]
  34. BuninB.A. DenerJ.M. LivingstonD.A. Application of combinatorial and parallel synthesis to medicinal chemistry.Annu. Rep. Med. Chem.199934267286[Academic Press].10.1016/S0065‑7743(08)60589‑8
     [Google Scholar]
  35. SinghM.S. ChowdhuryS. KoleyS. Advances of azide-alkyne cycloaddition-click chemistry over the recent decade.Tetrahedron201672355257528310.1016/j.tet.2016.07.044
     [Google Scholar]
  36. CoxB. MerrittA.T. BinnieA. DonnellyM.C. ManderT.H. DenyerJ.C. EvansB. GreenD.V.S. LewisJ.A. VallerM.J. WatsonS.P. Application of high-throughput screening techniques to drug discovery.Prog. Med. Chem.2000378313310.1016/S0079‑6468(08)70058‑410845248
     [Google Scholar]
  37. MartisE. A. RadhakrishnanR. BadveR. R. High-throughput screening: The hits and leads of drug discovery-an overview.J. Appl. Pharma Sci201101010210
     [Google Scholar]
  38. O’ ConnorC.J. BeckmannH.S.G. SpringD.R. Diversity-oriented synthesis: Producing chemical tools for dissecting biology.Chem. Soc. Rev.201241124444445610.1039/c2cs35023h22491328
     [Google Scholar]
  39. PantaleãoS.Q. FernandesP.O. GonçalvesJ.E. MaltarolloV.G. HonorioK.M. Recent advances in the prediction of pharmacokinetics properties in drug design studies: A review.ChemMedChem202217120210054210.1002/cmdc.20210054234655454
     [Google Scholar]
  40. AkhtarJ. KhanA.A. AliZ. HaiderR. Shahar YarM. Structure-activity relationship (SAR) study and design strategies of nitrogen-containing heterocyclic moieties for their anticancer activities.Eur. J. Med. Chem.201712514318910.1016/j.ejmech.2016.09.02327662031
     [Google Scholar]
  41. SinghS. Preclinical pharmacokinetics: An approach towards safer and efficacious drugs.Curr. Drug Metab.20067216518210.2174/13892000677554155216472106
     [Google Scholar]
  42. CamposK.R. ColemanP.J. AlvarezJ.C. DreherS.D. GarbaccioR.M. TerrettN.K. TillyerR.D. TruppoM.D. ParmeeE.R. The importance of synthetic chemistry in the pharmaceutical industry.Science20193636424eaat080510.1126/science.aat080530655413
     [Google Scholar]
  43. AhmadA. HaneefM. AhmadN. KamalA. JaswaniS. KhanF. Biological synthesis of silver nanoparticles and their medical applications.(Review)World Acad. Sci. J.2024632210.3892/wasj.2024.237
     [Google Scholar]
  44. SiddiquiM.R. AlOthmanZ.A. RahmanN. Analytical techniques in pharmaceutical analysis: A review.Arab. J. Chem.201710S1409S142110.1016/j.arabjc.2013.04.016
     [Google Scholar]
  45. ShindeS. RajurkarV. Advances in high-performance liquid chromatography (HPLC) method development and validation: A comprehensive review.J. Drug Deliv Biother2024203162610.61920/jddb.v1i03.109
     [Google Scholar]
  46. Gas chromatography–mass spectrometry (GC-MS): A comprehensive review of synergistic combinations and their applications in the past two decades.J. Anal. Sci. Appl. Biotechnol.20235252
     [Google Scholar]
  47. JainR. Thin-layer chromatography in clinical chemistry.Practical Thin-Layer Chromatography A Multidisciplinary Approach.Routledge1996
     [Google Scholar]
  48. MopperK. StubbinsA. RitchieJ.D. BialkH.M. HatcherP.G. Advanced instrumental approaches for characterization of marine dissolved organic matter: extraction techniques, mass spectrometry, and nuclear magnetic resonance spectroscopy.Chem. Rev.2007107241944210.1021/cr050359b17300139
     [Google Scholar]
  49. ClaridgeT.D. High-resolution NMR techniques in organic chemistry.Amsterdam, NetherlandsElsevier201627
     [Google Scholar]
  50. GargE. ZubairM. Mass spectrometer.StatPearls.Treasure Island, FLStatPearls Publishing2025
     [Google Scholar]
  51. ShiL. HabibA. BiL. HongH. BegumR. WenL. Ambient ionization mass spectrometry: Application and prospective.Crit. Rev. Anal. Chem.20245461584163310.1080/10408347.2022.212484036206159
     [Google Scholar]
  52. MokariA. GuoS. BocklitzT. Exploring the steps of infrared (IR) spectral analysis: Pre-processing, (classical) data modelling, and deep learning.Molecules20232819688610.3390/molecules2819688637836728
     [Google Scholar]
  53. FringeliU.P. ATR and reflectance IR spectroscopy, applications.Encyclopedia of spectroscopy and spectrometry.ACADEMIC PRESS2000115129
     [Google Scholar]
  54. MandruA. ManeJ. MandapatiR. A review on UV-visible spectroscopy.J. Pharma Insights Res.202312091096
     [Google Scholar]
  55. PandikumarA. DeviK.S. Eds.; Disposable Electrochemical Sensors for Healthcare Monitoring: Material Properties and Design.Royal Society of Chemistry20212110.1039/9781839163364
     [Google Scholar]
  56. St. ClaireR.L. Capillary electrophoresis.Anal. Chem.1996681256958610.1021/a1960018a
     [Google Scholar]
  57. KraemerT. PaulL.D. Bioanalytical procedures for determination of drugs of abuse in blood.Anal. Bioanal. Chem.200738871415143510.1007/s00216‑007‑1271‑617468860
     [Google Scholar]
  58. HosseiniS. Vázquez-VillegasP. Rito-PalomaresM. Martinez-ChapaS.O. Enzyme-linked immunosorbent assay (ELISA): From A to Z.SingaporeSpringer20186711510.1007/978‑981‑10‑6766‑2
     [Google Scholar]
  59. LandonJ. MoffatA.C. The radioimmunoassay of drugs. A review.Analyst 1976101120122524310.1039/an9760100225773213
     [Google Scholar]
  60. GordonJ.L. BrownM.A. ReynoldsM.M. Cell-based methods for determination of efficacy for candidate therapeutics in the clinical management of cancer.Diseases2018648510.3390/diseases604008530249005
     [Google Scholar]
  61. ThakurA. TanZ. KameyamaT. El-KhateebE. NagpalS. MaloneS. JamwalR. NwabufoC.K. Bioanalytical strategies in drug discovery and development.Drug Metab. Rev.202153343445810.1080/03602532.2021.195960634310243
     [Google Scholar]
  62. SaundersM. Thermal analysis of pharmaceuticals.Principles and applications of thermal analysis.OxfordBlackwell Publishing200828632910.1002/9780470697702.ch8
     [Google Scholar]
  63. LoganathanS. ValapaR.B. MishraR.K. PugazhenthiG. ThomasS. Thermogravimetric analysis for characterization of nanomaterials.Thermal and rheological measurement techniques for nanomaterials characterization.Elsevier20176710810.1016/B978‑0‑323‑46139‑9.00004‑9
     [Google Scholar]
  64. ThakurS.S. Introduction to pharmaceutical thermal analysis: A teaching tool.2011Available from https://etd.ohiolink.edu/acprod/odb_etd/etd/r/1501/10?clear=10&p10_accession_num=csu1316880806
    [Google Scholar]
  65. WoolfsonM.M. An introduction to X-ray crystallography.Cambridge University Press199710.1017/CBO9780511622557
     [Google Scholar]
  66. MorettiE. SuteraG. CollodelG. The importance of transmission electron microscopy analysis of spermatozoa: Diagnostic applications and basic research.Syst Biol Reprod Med201662317118310.3109/19396368.2016.115524226980361
     [Google Scholar]
  67. GuptaP. RaiN. VermaA. GautamV. Microscopy based methods for characterization, drug delivery, and understanding the dynamics of nanoparticles.Med. Res. Rev.202444113816810.1002/med.2198137294298
     [Google Scholar]
  68. HuangW. Percie du SertN. VollertJ. RiceA.S.C. General principles of preclinical study design.Handb. Exp. Pharmacol.2019257556910.1007/164_2019_27731707471
     [Google Scholar]
  69. BahugunaA. KhanI. BajpaiV.K. KangS.C. MTT assay to evaluate the cytotoxic potential of a drug.Bangladesh J. Pharmacol.201712211511810.3329/bjp.v12i2.30892
     [Google Scholar]
  70. SupinoR. MTT assays.Meth Mol. Biol.19954313714910.1385/0‑89603‑282‑5:137
     [Google Scholar]
  71. HilscherovaK. JonesP.D. GraciaT. NewstedJ.L. ZhangX. SandersonJ.T. YuR.M. WuR.S. GiesyJ.P. Assessment of the effects of chemicals on the expression of ten steroidogenic genes in the H295R cell line using real-time PCR.Toxicol. Sci.2004811788910.1093/toxsci/kfh19115187238
     [Google Scholar]
  72. LillC.M. HansenJ. OlsenJ.H. BinderH. RitzB. BertramL. Impact of Parkinson’s disease risk loci on age at onset.Mov. Disord.201530684785010.1002/mds.2623725914293
     [Google Scholar]
  73. CopelandR.A. Evaluation of enzyme inhibitors in drug discovery: A guide for medicinal chemists and pharmacologists201310.1002/9781118540398
     [Google Scholar]
  74. PatilK.R. MahajanU.B. UngerB.S. GoyalS.N. BelemkarS. SuranaS.J. OjhaS. PatilC.R. Animal models of inflammation for screening of anti-inflammatory drugs: Implications for the discovery and development of phytopharmaceuticals.Int. J. Mol. Sci.20192018436710.3390/ijms2018436731491986
     [Google Scholar]
  75. AvilaA.M. BebenekI. BonzoJ.A. BourcierT. Davis BrunoK.L. CarlsonD.B. DubinionJ. ElayanI. HarroukW. LeeS.L. MendrickD.L. MerrillJ.C. PeretzJ. PlaceE. SaulnierM. WangeR.L. YaoJ. ZhaoD. BrownP.C. An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).Regul. Toxicol. Pharmacol.202011410466210.1016/j.yrtph.2020.10466232325112
     [Google Scholar]
  76. RuggeriB.A. CampF. MiknyoczkiS. Animal models of disease: Pre-clinical animal models of cancer and their applications and utility in drug discovery.Biochem. Pharmacol.201487115016110.1016/j.bcp.2013.06.02023817077
     [Google Scholar]
  77. GreavesP. Histopathology of preclinical toxicity studies: interpretation and relevance in drug safety evaluation.Academic Press2011
     [Google Scholar]
  78. HoP.M. BrysonC.L. RumsfeldJ.S. Medication adherence.Circulation2009119233028303510.1161/CIRCULATIONAHA.108.76898619528344
     [Google Scholar]
  79. PetersonL.R. ShanholtzerC.J. Tests for bactericidal effects of antimicrobial agents: Technical performance and clinical relevance.Clin. Microbiol. Rev.19925442043210.1128/CMR.5.4.4201423219
     [Google Scholar]
  80. HoldgateG. GeschwindnerS. BreezeA. DaviesG. ColcloughN. TemesiD. WardL. Biophysical methods in drug discovery from small molecule to pharmaceutical.Methods Mol. Biol.2013100832735510.1007/978‑1‑62703‑398‑5_12
     [Google Scholar]
  81. ParkH.M. WeberJ. CarlsonM. JelinekM.A. Abstract 3099: A new HTS ELISA for monitoring NRAS activity to expedite drug discovery.Cancer Res.2024846_Supplement30993099(Suppl.)10.1158/1538‑7445.AM2024‑3099
     [Google Scholar]
  82. FurmanD. DavisM.M. New approaches to understanding the immune response to vaccination and infection.Vaccine201533405271528110.1016/j.vaccine.2015.06.11726232539
     [Google Scholar]
  83. VembadiA. MenacheryA. QasaimehM.A. Cell cytometry: Review and perspective on biotechnological advances.Front. Bioeng. Biotechnol.2019714710.3389/fbioe.2019.0014731275933
     [Google Scholar]
  84. Barba-OstriaC. Carrera-PachecoS.E. Gonzalez-PastorR. Heredia-MoyaJ. Mayorga-RamosA. Rodríguez-PólitC. Zúñiga-MirandaJ. Arias-AlmeidaB. GuamánL.P. Evaluation of biological activity of natural compounds: Current trends and methods.Molecules20222714449010.3390/molecules2714449035889361
     [Google Scholar]
  85. StrömstedtA.A. FelthJ. BohlinL. Bioassays in natural product research - strategies and methods in the search for anti-inflammatory and antimicrobial activity.Phytochem. Anal.2014251132810.1002/pca.246824019222
     [Google Scholar]
  86. Rodríguez-AntonaC. TaronM. Pharmacogenomic biomarkers for personalized cancer treatment.J. Intern. Med.2015277220121710.1111/joim.1232125338550
     [Google Scholar]
  87. LeonardH. BlauwendraatC. KrohnL. FaghriF. IwakiH. FergusonG. Day-WilliamsA.G. StoneD.J. SingletonA.B. NallsM.A. Gan-OrZ. Genetic variability and potential effects on clinical trial outcomes: Perspectives in Parkinson’s disease.J. Med. Genet.202057533133810.1136/jmedgenet‑2019‑10628331784483
     [Google Scholar]
  88. BlauwendraatC. IwakiH. MakariousM.B. Bandres-CigaS. LeonardH.L. GrennF.P. LakeJ. KrohnL. TanM. KimJ.J. GibbsJ.R. HernandezD.G. RuskeyJ.A. PihlstrømL. ToftM. van HiltenJ.J. MarinusJ. SchulteC. BrockmannK. SharmaM. SiitonenA. MajamaaK. Eerola-RautioJ. TienariP.J. GrossetD.G. LesageS. CorvolJ.C. BriceA. WoodN. HardyJ. Gan-OrZ. HeutinkP. GasserT. MorrisH.R. NoyceA.J. NallsM.A. SingletonA.B. Investigation of autosomal genetic sex differences in parkinson’s disease.Ann. Neurol.2021901354210.1002/ana.2609033901317
     [Google Scholar]
  89. JainK.K. An overview of drug delivery systems.Methods Mol. Biol.2020205915410.1007/978‑1‑4939‑9798‑5_131435914
     [Google Scholar]
  90. WenH. ParkK. Eds.; Oral controlled release formulation design and drug delivery: theory to practice.2011
     [Google Scholar]
  91. ManchandaS. DasN. ChandraA. BandyopadhyayS. ChaurasiaS. Fabrication of advanced parenteral drug-delivery systems.Drug Delivery Systems.Academic Press2020478410.1016/B978‑0‑12‑814487‑9.00002‑8
     [Google Scholar]
  92. VaseemR.S. D’cruzA. ShettyS. HafsaH. VardhanA. R, S.S.; Marques, S.M.; Kumar, L.; Verma, R. Transdermal drug delivery systems: A focused review of the physical methods of permeation enhancement.Adv. Pharm. Bull.20241416785[PMID: 38585458
     [Google Scholar]
  93. BhatiaS. BhatiaS. Nanoparticles types, classification, characterization, fabrication methods and drug delivery applications.Natural Polymer Drug Delivery Systems.ChamSpringer201610.1007/978‑3‑319‑41129‑3_2
     [Google Scholar]
  94. MaliS. Delivery systems for gene therapy.Indian J. Hum. Genet.20131913810.4103/0971‑6866.11287023901186
     [Google Scholar]
  95. GonçalvesG.A.R. PaivaR.M.A. Gene therapy: Advances, challenges and perspectives.Einstein 201715336937510.1590/s1679‑45082017rb402429091160
     [Google Scholar]
  96. KumarA. PillaiJ. Implantable drug delivery systems: An overview.Nanostructures for the Engineering of Cells, Tissues and Organs201847351110.1016/B978‑0‑12‑813665‑2.00013‑2
     [Google Scholar]
  97. PatelA. CholkarK. AgrahariV. MitraA.K. Ocular drug delivery systems: An overview.World J. Pharmacol.201322476410.5497/wjp.v2.i2.4725590022
     [Google Scholar]
  98. Arévalo-PérezR. MaderueloC. LanaoJ.M. Recent advances in colon drug delivery systems.J. Control. Release202032770372410.1016/j.jconrel.2020.09.02632941930
     [Google Scholar]
  99. CamiloC.J.J. LeiteD.O.D. SilvaA.R.A. MenezesI.R.A. CoutinhoH.D.M. CostaJ.G.M. Lipid vesicles: Applications, principal components and methods used in their formulations: A review.Acta Biol. Colomb.202025233935210.15446/abc.v25n2.74830
     [Google Scholar]
  100. JayakumarA. JoseV.K. LeeJ.M. Hydrogels for medical and environmental applications.Small Methods202043190073510.1002/smtd.201900735
     [Google Scholar]
  101. CongX. ChenJ. XuR. Recent progress in bio-responsive drug delivery systems for tumor therapy.Front. Bioeng. Biotechnol.20221091695210.3389/fbioe.2022.91695235845404
     [Google Scholar]
  102. HalbertG. Pharmaceutical development.The Textbook of Pharmaceutical Medicine.United StatesAcademic Press200981100
     [Google Scholar]
  103. PrabhakarM.K. SiddiquiA.W. Analyses of the anti-diabetic activity of Lactuca sativa (L.) seeds from various geographical regions. J. ReAttach Ther.Dev. Divers2023610s (2)18211828
     [Google Scholar]
  104. De VilliersM.M. Oral conventional solid dosage forms: Powders and granules, tablets, lozenges, and capsules.Theory and Practice of Contemporary Pharmaceutics.CRC press202127933110.1201/9780203644478‑13
     [Google Scholar]
  105. TanA. RaoS. PrestidgeC.A. Transforming lipid-based oral drug delivery systems into solid dosage forms: An overview of solid carriers, physicochemical properties, and biopharmaceutical performance.Pharm. Res.201330122993301710.1007/s11095‑013‑1107‑323775443
     [Google Scholar]
  106. MaqboolA. MishraM.K. PathakS. KesharwaniA. KesharwaniA. Semisolid dosage forms manufacturing: Tools, critical process parameters, strategies, optimization, and recent advances.Ind. Am J. Pharm. Res.20177882893
     [Google Scholar]
  107. AnsariM.T. SrivastavaD. AliO.A.M.A. HauT.W. SamiF. HasnainM.S. Advances in semisolid dosage form.Dosage For.Formul Devel Regulat202451954210.1016/B978‑0‑323‑91817‑6.00018‑8
     [Google Scholar]
  108. BialerM. Extended-release formulations for the treatment of epilepsy.CNS Drugs200721976577410.2165/00023210‑200721090‑0000517696575
     [Google Scholar]
  109. SuriS.S. FenniriH. SinghB. Nanotechnology-based drug delivery systems.J. Occup. Med. Toxicol.2007211610.1186/1745‑6673‑2‑1618053152
     [Google Scholar]
  110. ChimeA. OnyishiI.V. Lipid-based drug delivery systems (LDDS): Recent advances and applications of lipids in drug delivery.Afr. J. Pharm. Pharmacol.20137483034305910.5897/AJPPX2013.0004
     [Google Scholar]
  111. LeeJ.H. YeoY. Controlled drug release from pharmaceutical nanocarriers.Chem. Eng. Sci.2015125758410.1016/j.ces.2014.08.04625684779
     [Google Scholar]
  112. SinghM.N. HemantK.S. RamM. ShivakumarH.G. Microencapsulation: A promising technique for controlled drug delivery.Res. Pharm. Sci.2010526577[PMID: 21589795
     [Google Scholar]
  113. UgaleS. NannorK.M. The role of excipients in enhancing drug delivery and stability: A comprehensive review.2024Available from https://www.ijpsjournal.com/article/The+Impact+of+Excipients+on+Pharmaceutical+Product+Quality+Review+the+role+of+excipients+in+pharmaceutical+product+quality
    [Google Scholar]
  114. JadhavT.R. MoonR.S. Review on lyophilization technique.World J. Pharm. Pharm. Sci.20154519061928
     [Google Scholar]
  115. BhandariM. BobadeH. SharmaR. SharmaS. Mixing, blending, and emulsification in processing.Engineering Solutions for Sustainable Food. and Dairy Production. DekaS. NickhilC. HaghiA.K. ChamSpringer202510.1007/978‑3‑031‑75834‑8_9
     [Google Scholar]
  116. MalamatariM. CharisiA. MalamatarisS. KachrimanisK. NikolakakisI. Spray drying for the preparation of nanoparticle-based drug formulations as dry powders for inhalation.Processes20208778810.3390/pr8070788
     [Google Scholar]
  117. TamboliT.H. ManeS.R. BaisS.K. Navigating compliance: The integral role of regulatory affairs in pharmaceutical industry.Int. J. Pharm. Herb Technol2024224472460
     [Google Scholar]
  118. SharmaS.M. SharmaR. ChandrateyaP. SardanaS. Advancing drug chemical stability: Unravelling recent developments and regulatory considerations.2024Available from https://www.researchgate.net/publication/379928758_Advancing_Drug_Chemical_Stability_Unravelling_Recent_Developments_and_Regulatory_Considerations
    [Google Scholar]
  119. CharpentierJ.C. The triplet “molecular processes–product–process” engineering: The future of chemical engineering?Chem. Eng. Sci.20025722-234667469010.1016/S0009‑2509(02)00287‑7
     [Google Scholar]
  120. BorgheiniG. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoative drugs.Clin. Ther.20032561578159210.1016/S0149‑2918(03)80157‑112860486
     [Google Scholar]
  121. QureshiS. A. In vitro-in vivo correlation (IVIVC) and determining drug concentrations in blood from dissolution testing – A simple and practical approach.Open Drug Deliv J201041
     [Google Scholar]
  122. ChaudhryaD.A. FatimabU. WaqarcK. RehmandM. Pharmacokinetic modeling concepts: Compartmental and non compartmental approach for drug designing2016Available from: https://www.gdddrjournal.com/fulltext/pharmacokinetic-modeling-concepts-compartmental-and-noncompartmental-approach-for-drug-designing/393091#:~:text=The%20physiologically%20based%20pharmacokinetic%20models,not%20require%20any%20compartment%20model
  123. SucharithaP. ReddyK.R. SatyanarayanaS.V. GargT. Absorption, distribution, metabolism, excretion, and toxicity assessment of drugs using computational tools.Computational approaches for novel therapeutic and diagnostic designing to mitigate SARS-CoV-2 infection.Academic Press202233535510.1016/B978‑0‑323‑91172‑6.00012‑1
     [Google Scholar]
  124. BairdR.M. Microbial spoilage, infection risk and contamination control.Hugo and Russell’s Pharmaceutical Microbiology.Seventh edHoboken, New JerseyWiley Online Library2004
     [Google Scholar]
  125. DressmanJ.B. AmidonG.L. ReppasC. ShahV.P. Dissolution testing as a prognostic tool for oral drug absorption: Immediate release dosage forms.Pharm. Res.1998151112210.1023/A:10119842167759487541
     [Google Scholar]
  126. WatermanK.C. AdamiR.C. Accelerated aging: Prediction of chemical stability of pharmaceuticals.Int. J. Pharm.20052931-210112510.1016/j.ijpharm.2004.12.01315778049
     [Google Scholar]
  127. ChaJ. GilmorT. LaneP. RanweilerJ.S. Stability studies.Sep. Sci. Technol.201110459505
     [Google Scholar]
  128. BajajS. SinglaD. SakhujaN. Stability testing of pharmaceutical products.J. Appl. Pharm. Sci.2012129138
     [Google Scholar]
  129. KlickS. MuijselaarP.G. WatervalJ. EichingerT. KornC. GerdingT.K. Stress testing of drug substances and drug products.Pharm. Technol.20052924866
     [Google Scholar]
  130. FasaniE. AlbiniA. Photostability stress testing.Pharmaceutical Stress Testing.CRC Press2016204229
     [Google Scholar]
  131. VyasA.J. PatelS.M. PatelA.B. PatelA.I. PatelN.K. ShahS. ShethD. Stability testing: An essential study for vaccine formulation development.Asian J. Pharm. Res.2022121293610.52711/2231‑5691.2022.00006
     [Google Scholar]
  132. KumruO.S. JoshiS.B. SmithD.E. MiddaughC.R. PrusikT. VolkinD.B. Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies.Biologicals201442523725910.1016/j.biologicals.2014.05.00724996452
     [Google Scholar]
  133. DaoH. LakhaniP. PoliceA. KallakuntaV. AjjarapuS.S. WuK.W. PonksheP. RepkaM.A. Narasimha MurthyS. Microbial stability of pharmaceutical and cosmetic products.AAPS PharmSciTech2018191607810.1208/s12249‑017‑0875‑129019083
     [Google Scholar]
  134. AmarjiB. KulkarniA. DebP.K. MaheshwariR. TekadeR.K. Package development of pharmaceutical products: Aspects of packaging materials used for pharmaceutical products.Dosage Form Design Parameters.Academic Press201852155210.1016/B978‑0‑12‑814421‑3.00015‑4
     [Google Scholar]
  135. BhangareD. RajputN. JadavT. SahuA.K. TekadeR.K. SenguptaP. Systematic strategies for degradation kinetic study of pharmaceuticals: An issue of utmost importance concerning current stability analysis practices.J. Anal. Sci. Technol.2022131710.1186/s40543‑022‑00317‑6
     [Google Scholar]
  136. KimJ.H. LeeK. JerngU.M. ChoiG. Global comparison of stability testing parameters and testing methods for finished herbal products.Evid. Based Complement. Alternat. Med.20192019111410.1155/2019/734892931772599
     [Google Scholar]
  137. Finotti CordeiroC. Lopardi FrancoL. Teixeira CarvalhoD. BonfilioR. Impurities in active pharmaceutical ingredients and drug products: A critical review.Crit. Rev. Anal. Chem.202412110.1080/10408347.2024.238404639058576
     [Google Scholar]
  138. JameelF. HershensonS. Eds.; Formulation and process development strategies for manufacturing biopharmaceuticals.201010.1002/9780470595886
     [Google Scholar]
  139. BhattacharjeeS. SarkarB. Ranjan SharmaA. GuptaP. SharmaG. LeeS.S. ChakrabortyC. Formulation and application of biodegradable nanoparticles based biopharmaceutical delivery-an efficient delivery system.Curr. Pharm. Des.201622203020303310.2174/138161282266616030715124126951099
     [Google Scholar]
  140. MahlerH.C. AllmendingerA. Stability, formulation, and delivery of biopharmaceuticals.Protein Therapeutics; Wiley2017246949110.1002/9783527699124.ch14
     [Google Scholar]
  141. FrokjaerS. OtzenD.E. Protein drug stability: A formulation challenge.Nat. Rev. Drug Discov.20054429830610.1038/nrd169515803194
     [Google Scholar]
  142. KhanS. UllahM.W. SiddiqueR. NabiG. MananS. YousafM. HouH. Role of recombinant DNA technology to improve life.Int. J. Genomics20162016111410.1155/2016/240595428053975
     [Google Scholar]
  143. FreshneyR.I. Culture of animal cells: A manual of basic technique and specialized applications2015
     [Google Scholar]
  144. AhmadS. DahiyaV. VibhutiA. PandeyR.P. TripathiM.K. YadavM.K. Therapeutic protein-based vaccines.Protein-based therapeutics.SingaporeSpringer Nature Singapore202335538410.1007/978‑981‑19‑8249‑1_13
     [Google Scholar]
  145. GodingJ.W. Monoclonal antibodies: Principles and practice.Elsevier1996
     [Google Scholar]
  146. SayedN. AllawadhiP. KhuranaA. SinghV. NavikU. PasumarthiS.K. KhuranaI. BanothuA.K. WeiskirchenR. BharaniK.K. Gene therapy: Comprehensive overview and therapeutic applications.Life Sci.202229412037510.1016/j.lfs.2022.12037535123997
     [Google Scholar]
  147. BulchaJ.T. WangY. MaH. TaiP.W.L. GaoG. Viral vector platforms within the gene therapy landscape.Signal Transduct. Target. Ther.2021615310.1038/s41392‑021‑00487‑633558455
     [Google Scholar]
  148. MitraS. MurthyG.S. Bioreactor control systems in the biopharmaceutical industry: A critical perspective.Systems Microbiology and Biomanufacturing2022219111210.1007/s43393‑021‑00048‑638624976
     [Google Scholar]
  149. GuptaS. PellettS. Recent developments in vaccine design: From live vaccines to recombinant toxin vaccines.Toxins202315956310.3390/toxins1509056337755989
     [Google Scholar]
  150. BrisseM. VrbaS.M. KirkN. LiangY. LyH. Emerging concepts and technologies in vaccine development.Front. Immunol.20201158307710.3389/fimmu.2020.58307733101309
     [Google Scholar]
  151. EmejeM.O. ObidikeI.C. AkpabioE.I. OfoefuleS.I. Nanotechnology in drug delivery. Recent Adv.Novel Drug Carr Sys20121469106
     [Google Scholar]
  152. KennedyP.J. OliveiraC. GranjaP.L. SarmentoB. Monoclonal antibodies: Technologies for early discovery and engineering.Crit. Rev. Biotechnol.201838339440810.1080/07388551.2017.135700228789584
     [Google Scholar]
  153. AljabaliA.A.A. El-TananiM. TambuwalaM.M. Principles of CRISPR-Cas9 technology: Advancements in genome editing and emerging trends in drug delivery.J. Drug Deliv. Sci. Technol.20249210533810.1016/j.jddst.2024.105338
     [Google Scholar]
  154. ButlerM. Meneses-AcostaA. Recent advances in technology supporting biopharmaceutical production from mammalian cells.Appl. Microbiol. Biotechnol.201296488589410.1007/s00253‑012‑4451‑z23053101
     [Google Scholar]
  155. PietzschJ.B. ShluzasL.A. Paté-CornellM.E. YockP.G. LinehanJ.H. Stage-gate process for the development of medical devices.ASME J. Med. Dev.20093202100410.1115/1.3148836
     [Google Scholar]
  156. DiMasiJ.A. Risks in new drug development: Approval success rates for investigational drugs.Clin. Pharmacol. Ther.200169529730710.1067/mcp.2001.11544611371997
     [Google Scholar]
  157. UmscheidC.A. MargolisD.J. GrossmanC.E. Key concepts of clinical trials: A narrative review.Postgrad. Med.2011123519420410.3810/pgm.2011.09.247521904102
     [Google Scholar]
  158. PiantadosiS. Clinical trials: A methodologic perspective2024
     [Google Scholar]
  159. BondemarkL. RufS. Randomized controlled trial: The gold standard or an unobtainable fallacy?Eur. J. Orthod.201537545746110.1093/ejo/cjv04626136438
     [Google Scholar]
  160. GrimesD.A. SchulzK.F. Cohort studies: Marching towards outcomes.Lancet2002359930334134510.1016/S0140‑6736(02)07500‑111830217
     [Google Scholar]
  161. SavitzD.A. WelleniusG.A. Can cross-sectional studies contribute to causal inference? It depends.Am. J. Epidemiol.2023192451451610.1093/aje/kwac03735231933
     [Google Scholar]
  162. SchlesselmanJ.J. Case-control studies: Design, conduct, analysis.Oxford university press19822
     [Google Scholar]
  163. MonaghanT.F. AgudeloC.W. RahmanS.N. WeinA.J. LazarJ.M. EveraertK. DmochowskiR.R. Blinding in clinical trials: Seeing the big picture.Medicina202157764710.3390/medicina5707064734202486
     [Google Scholar]
  164. SaghaeiM. An overview of randomization and minimization programs for randomized clinical trials.J. Med. Signals Sens.201111556110.4103/2228‑7477.8352022606659
     [Google Scholar]
  165. HróbjartssonA. GøtzscheP.C. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.N. Engl. J. Med.2001344211594160210.1056/NEJM20010524344210611372012
     [Google Scholar]
  166. WilsonM.K. KarakasisK. OzaA.M. Outcomes and endpoints in trials of cancer treatment: The past, present, and future.Lancet Oncol.2015161e32e4210.1016/S1470‑2045(14)70375‑425638553
     [Google Scholar]
  167. WaltherB. HossinS. TownendJ. AbernethyN. ParkerD. JeffriesD. Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data.PLoS One2011692534810.1371/journal.pone.002534821966505
     [Google Scholar]
  168. Armijo-OlivoS. Barbosa-SilvaJ. de Castro-CarlettiE.M. de Oliveira-SouzaA.I.S. PelaiE.B. MohamadN. BaghbaninaghadehiF. DennettL. SteenJ.P. KumbhareD. BallenbergerN. Intention to treat analysis in clinical research: Basic concepts for clinicians.Am. J. Phys. Med. Rehabil.2024103984585710.1097/PHM.000000000000244438320245
     [Google Scholar]
  169. KimW.O. Institutional review board (IRB) and ethical issues in clinical research.Korean J. Anesthesiol.201262131210.4097/kjae.2012.62.1.322323947
     [Google Scholar]
  170. BrodyT. Clinical trials: study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines.Academic press201610.1016/B978‑0‑12‑804217‑5.00002‑3
     [Google Scholar]
  171. ChetlapalliH. Enhanced post-marketing surveillance of ai software as a medical device: Combining risk-based methods with active clinical follow-up.Int. J. Res. Eng. Technol.2021116114
     [Google Scholar]
  172. RobinsonK.A. DennisonC.R. WaymanD.M. PronovostP.J. NeedhamD.M. Systematic review identifies number of strategies important for retaining study participants.J. Clin. Epidemiol.2007608757.e1757.e1910.1016/j.jclinepi.2006.11.02317606170
     [Google Scholar]
  173. FromellG.J. Good clinical practice standards: What they are and some tools to support them.Hum. Gene Ther.200819543144010.1089/hum.2008.050818507512
     [Google Scholar]
  174. Salcher-KonradM. NaciH. DavisC. Approval of cancer drugs with uncertain therapeutic value: A comparison of regulatory decisions in Europe and the United States.Milbank Q.20209841219125610.1111/1468‑0009.1247633021339
     [Google Scholar]
  175. BennJ. KoutantjiM. WallaceL. SpurgeonP. RejmanM. HealeyA. VincentC. Feedback from incident reporting: Information and action to improve patient safety.Qual. Saf. Health Care2009181112110.1136/qshc.2007.02416619204126
     [Google Scholar]
  176. AroteK.S. SaladeD.A. PatilN.V. A brief review on regulatory affairs: Ensuring compliance, safety, and market access.Int. J. Pharma Sci.202310911
     [Google Scholar]
  177. Van NormanG.A. Drugs, devices, and the FDA: Part 1.JACC Basic Transl. Sci.20161317017910.1016/j.jacbts.2016.03.00230167510
     [Google Scholar]
  178. WilliamsC.T. Food and drug administration drug approval process.Nurs. Clin. North Am.201651111110.1016/j.cnur.2015.10.00726897420
     [Google Scholar]
  179. MilneC-P. Prospects for rapid advances in the development of new medicines for special medical needs.Clin. Pharmacol. Ther.20139519810910.1038/clpt.2013.15523917473
     [Google Scholar]
  180. GammieT. LuC.Y. BabarZ.U.D. Access to orphan drugs: A comprehensive review of legislations, regulations and policies in 35 countries.PLoS One20151010014000210.1371/journal.pone.014000226451948
     [Google Scholar]
  181. HiraniK. MittalR. BansinathM. LemosJ.R. A primer on Food and Drug Administration’s approval process.Proteomics, Multi-Omics and Systems Biology in Optic Nerve Regeneration. BhattacharyaS.K. United StatesAcademic Press202534935810.1016/B978‑0‑443‑15580‑2.00024‑2
     [Google Scholar]
  182. AhmadM. ByersV. WilsonP. Regulatory issues (FDA and EMA).Vaccinology: Principles and Practice.Hoboken, New JerseyWiley Online Library2012
     [Google Scholar]
  183. JohnsonJ.A. FDA regulation of medical devices.2012Available from https://www2.law.umaryland.edu/marshall/crsreports/crsdocuments/R42130_06252012.pdf
    [Google Scholar]
  184. FlynnR. PlueschkeK. QuintenC. StrassmannV. DuijnhovenR.G. Gordillo-MarañonM. RueckbeilM. CohetC. KurzX. Marketing authorization applications made to the European medicines agency in 2018–2019: what was the contribution of real‐world evidence?Clin. Pharmacol. Ther.20221111909710.1002/cpt.246134689339
     [Google Scholar]
  185. GuptaD.K. TiwariA. YadavY. SoniP. JoshiM. Ensuring safety and efficacy in combination products: Regulatory challenges and best practices.Frontiers in Medical Technology.20246137744310.3389/fmedt.2024.137744339050909
     [Google Scholar]
  186. MorganM.G. Use (and abuse) of expert elicitation in support of decision making for public policy.Proc. Natl. Acad. Sci. USA2014111207176718410.1073/pnas.131994611124821779
     [Google Scholar]
  187. FisherW.O. Key disclosure issues for life sciences companies: FDA product approval, clinical test results, and government inspections.Mich. Telecommun. Technol. Law Rev.20018115
     [Google Scholar]
  188. AlgorriM. CauchonN.S. ChristianT. O’ConnellC. VaidyaP. Patient-Centric product development: A summary of select regulatory CMC and device considerations.J. Pharm. Sci.2023112492293610.1016/j.xphs.2023.01.02936739904
     [Google Scholar]
  189. JoshiH.A. A regulatory comparison study of generic medicines between Canada and Europe with focus on approval and post-approval processes.Doctoral dissertation, Institute of Pharmacy, Nirma University, A'bad2017
     [Google Scholar]
  190. ChenB.K. YangY.T. Post-marketing surveillance of prescription drug safety: Past, present, and future.J. Leg. Med.201334219321310.1080/01947648.2013.80079723980746
     [Google Scholar]
  191. ZhangX. ZhangY. YeX. GuoX. ZhangT. HeJ. Overview of phase IV clinical trials for postmarket drug safety surveillance: A status report from the ClinicalTrials.gov registry.BMJ Open201661101064310.1136/bmjopen‑2015‑01064327881517
     [Google Scholar]
  192. FritscheE. ElsallabM. SchadenM. HeyS.P. Abou-El-EneinM. Post-marketing safety and efficacy surveillance of cell and gene therapies in the EU: A critical review.Cell Gene Ther. Insights20195111505152110.18609/cgti.2019.156
     [Google Scholar]
  193. ZhuR. VoraB. MenonS. YounisI. DwivediG. MengZ. Datta-MannanA. ManchandaniP. NayakS. TammaraB.K. GarhyanP. IqbalS. DagenaisS. ChanuP. MukherjeeA. GhobadiC. Clinical pharmacology applications of real‐world data and real‐world evidence in drug development and approval–an industry perspective.Clin. Pharmacol. Ther.2023114475176710.1002/cpt.298837393555
     [Google Scholar]
  194. TunisS.R. StryerD.B. ClancyC.M. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy.JAMA2003290121624163210.1001/jama.290.12.162414506122
     [Google Scholar]
  195. AhmedR. The role of cGMP in the manufacturing unit of a pharmaceutical industry. Radinka.J. Health. Sci.20242224225310.56778/rjhs.v2i2.361
     [Google Scholar]
  196. GrooverM.P. Fundamentals of modern manufacturing: Materials, processes, and systems.2010
     [Google Scholar]
  197. RetsinG. GarciaM.J. SolerV. Discrete computation for additive manufacturing.Fabricate20172017178183
     [Google Scholar]
  198. KuoE. MillerR.J. Automated custom-manufacturing technology in orthodontics.Am. J. Orthod. Dentofacial Orthop.2003123557858110.1016/S0889‑5406(03)00051‑912750680
     [Google Scholar]
  199. RossD.F. RogersJ. Distribution: Planning and control: London199626331910.1007/978‑1‑4684‑0015‑1_7
     [Google Scholar]
  200. MostaracK. KavranZ. PiskovicJ.L. Dropshipping distribution model in supply chain management.Proceedings of the 31st DAAAM International SymposiumJanuary 202010.2507/31st.daaam.proceedings.019
     [Google Scholar]
  201. DentJ. Distribution channels: Understanding and managing channels to market.Kogan Page Publishers2011
     [Google Scholar]
  202. HittM.A. KeatsB.W. DeMarieS.M. Navigating in the new competitive landscape: Building strategic flexibility and competitive advantage in the 21st century.Acad. Manage. Perspect.1998124224210.5465/ame.1998.1333922
     [Google Scholar]
  203. ZachariaZ.G. SandersN.R. NixN.W. The emerging role of the third‐party logistics provider (3PL) as an orchestrator.J. Bus. Logist.2011321405410.1111/j.2158‑1592.2011.01004.x
     [Google Scholar]
  204. KurbelK.E. Enterprise resource planning and supply chain management.Functions, Business Processes and Software for Manufacturing Companies Progress in IS.DordrechtSpringer2013
     [Google Scholar]
  205. MuennigP. BounthavongM. Cost-effectiveness analysis in health: A practical approach2016
     [Google Scholar]
  206. PereiraC.S.S.M. Examining the role of market access in the pharmaceutical industry: A scoping review of european practices.Thesis, Doctoral Dissertation.2023
     [Google Scholar]
  207. McGhanW.F. ArnoldR.J. Introduction to pharmacoeconomics.Pharmacoeconomics.CRC Press202012010.1201/9780429491368‑1
     [Google Scholar]
  208. DraboE.F. EdokaI. PadulaW.V. Overview of decision analysis and cost-effectiveness.Handbook of Applied Health. Economics in Vaccines. BishaiD. BrenzelL. PadulaW. OxfordOxford University Press202310.1093/oso/9780192896087.003.0014
     [Google Scholar]
  209. CusterB. Health economics in blood safety.Blood Safety. ShanH. DoddR. ChamSpringer201910.1007/978‑3‑319‑94436‑4_4
     [Google Scholar]
  210. ThomasD. HiligsmannM. JohnD. Al AhdabO.G. LiH. Pharmacoeconomic analyses and modeling.Clinical pharmacy education, practice and research.Elsevier201926127510.1016/B978‑0‑12‑814276‑9.00018‑0
     [Google Scholar]
  211. ŠmitR. Health. Economics of Tick-borne Diseases.Rijksuniversiteit Groningen2016
     [Google Scholar]
  212. VoglerS. ParisV. FerrarioA. WirtzV.J. de JoncheereK. SchneiderP. PedersenH.B. DedetG. BabarZ.U.D. How can pricing and reimbursement policies improve affordable access to medicines? Lessons learned from European countries.Appl. Health Econ. Health Policy201715330732110.1007/s40258‑016‑0300‑z28063134
     [Google Scholar]
  213. Van NormanG.A. Drugs and devices.JACC Basic Transl. Sci.20161539941210.1016/j.jacbts.2016.06.00330167527
     [Google Scholar]
  214. BerndtE.R. NewhouseJ.P. Pricing and reimbursement.CambridgePharmaceutical Markets2010
     [Google Scholar]
  215. PrajapatiV. DurejaH. Product lifecycle management in pharmaceuticals.J. Med. Mark.201212315015810.1177/1745790412445292
     [Google Scholar]
  216. VondelingG.T. CaoQ. PostmaM.J. RozenbaumM.H. The impact of patent expiry on drug prices: A systematic literature review.Appl. Health Econ. Health Policy201816565366010.1007/s40258‑018‑0406‑630019138
     [Google Scholar]
  217. Wikipedia contributors. 2024. Available from: https://en.wikipedia.org/w/index.php?title=Off-label_use&oldid=1246967150
  218. KesselheimA.S. SinhaM.S. AvornJ. Determinants of market exclusivity for prescription drugs in the United States.JAMA Intern. Med.2017177111658166410.1001/jamainternmed.2017.432928892528
     [Google Scholar]
  219. KrauseJ.H. SaverR.S. Real-world evidence in the real world: Beyond the FDA.Am. J. Law Med.2018442-316117910.1177/009885881878942330106647
     [Google Scholar]
  220. YoshitaniR.S. CooperE.S. Pharmaceutical reformulation: The growth of life cycle management20077379
     [Google Scholar]
  221. RomleyJ.A. XieZ. ChiouT. GoldmanD. PetersA.L. Extended-release formulation and medication adherence.J. Gen. Intern. Med.202035135435610.1007/s11606‑019‑05275‑131659657
     [Google Scholar]
/content/journals/ctmc/10.2174/0115680266397266250725101317
Loading
Pharmaceutical Sciences Encompass A Wide Range of Techniques and Methodologies
Curr. Top. Med. Chem. 26, 58 (2026); https://doi.org/10.2174/0115680266397266250725101317
/content/journals/ctmc/10.2174/0115680266397266250725101317
/content/journals/ctmc/10.2174/0115680266397266250725101317
Loading

Data & Media loading...


  • Article Type:     Review Article
Keyword(s): Methodologies; Pharmaceutical industry; Pharmaceutical research and development; Pharmaceuticals; Systematic approach; Techniques

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test