Clinical Trials & Regulatory Affairs
Advancing Regulatory Framework with AI: A Step Towards Quicker Medication
While extending treatment protocols and refining systematic processes within the healthcare industry presents immense promise artificial intelligence (AI) comes along with multiple benefits. It would arrive at accurate diagnoses of diseases help generate personalized treatment plans facilitate corporate interactions in healthcare systems and benefit both patients and healthcare organizations. With the evolving trends in AI the healthcare domain expects to see substantial effects in the coming few years hence calling for strong regulation to ensure the protection of human ethics and practical application. The establishment of common regulatory frameworks will enable responsible usages of AI while accentuating patient rights and privacy concerns. AI is changing how drug approvals are done through positive interventions on both the time and cost aspects.
Whereas traditional drug development takes anywhere from 5.5 years to 14.5 years AI has shortened this time frame for target discovery to a preclinical candidate to as little as 18 months. Furthermore AI has reduced development costs by nearly 50% thus rendering development more efficient while enhancing the accuracy of predictions of the efficacy and safety of drugs. The stepped integration of AI into drug approval processes accelerates innovations by providing cost-effective solutions and enhancing precision that eventually benefits both patients and healthcare organizations.
Efficacy of Nanofiber Mats Loaded with 5-Fluorouracil and Rosemary Extract on Actinic Keratosis: A Randomized Double-blinded Clinical Trial
Actinic keratosis (AK) is a precancerous skin condition caused by abnormal growth of epidermal keratinocytes. Current treatments like 5-fluorouracil (5-FU) cream have limitations. Rosemary extract has shown anticancer and antioxidant properties enhancing the effects of 5-FU. Nanofibers are a potential drug delivery system due to their unique properties. Thus this study aimed to investigate the efficacy of 5-FU and rosemary extract-loaded nanofibers in AK treatment.
Polymeric nanofibers loaded with 5-FU and rosemary extract were created using electrospinning. A randomized controlled double-blinded clinical trial was conducted on AK patients divided into three groups: Group A (nanofibers with 5% 5-FU and rosemary extract) Group B (nanofibers with 5% 5-FU) and Group C (5% 5-FU cream). Improvement satisfaction and side effects were assessed using visual analogue scale (VAS) scores and the modified Investigator Global Improvement Score.
Group A exhibited significantly higher global improvement scores compared to Group B (p value<0.001). Group A also had the highest VAS score indicating greater patient satisfaction. Side effects were lowest in Group A and highest in Group C.
This randomized double-blinded clinical trial suggests that nanofibers loaded with 5-FU and rosemary extract (Group A) are more effective in improving AK lesions compared to nanofibers with 5-FU alone (Group B) and 5-FU cream (Group C). Group A also showed higher patient satisfaction and fewer side effects. The combination of 5-FU and rosemary extract in nanofibers holds promise as an alternative treatment for AK. Further studies are needed to validate these findings and investigate the long-term effects of the treatment.
IRCT20210118050067N1.
Misery of Long Haulers of COVID-19 - A Review
Early in December 2019 Wuhan City Hubei Province China had an epidemic of the Coronavirus illness 2019 (COVID-19) which was brought on by a brand-new severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). The epidemic was deemed a Public Health Emergency of International Concern by the World Health Organization on January 30 2020. Many governments have implemented a range of control measures as a result of perceived illness risk.
The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs including the heart and brain raising the risk of long-term health consequences. The illness can affect someone's health even after recovery in a variety of ways. The long-term effects of COVID-19 on locals are still being researched. The objective is to compile knowledge regarding the virus and the present Post pandemic complications in Long Haulers.
We reviewed the body of publicly available literature. To discover publications published between December 2019 and October 2020 we conducted a systematic search utilizing the keywords in online databases such as Pub Med Scopus Science Direct Up to Date and Web of Science. The review includes peer-reviewed original publications published that matched the qualifying requirements.
Although the majority of patients recovered quickly after receiving COVID-19 the possibility of long-term issues induced by COVID-19 necessitates the search for and research of its late consequences. This article aims to provide a comprehensive assessment of COVID-19 late complications in order to determine how prevalent these symptoms are and who is most likely to be impacted.
There are a number of difficulties with the COVID-19 pandemic that has yet to be resolved. Review of the literature reported several long-lasting clinical problems that affect different phases of health including chronic fatigue reduced physical capacity muscle weakness increased depression anxiety post-traumatic stress disorder and sleep problems. A complete turndown in quality of life has been observed even one year after major Coronavirus outbreaks.
The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs including the heart and brain raising the risk of long-term health consequences even after years making them to be “Long Haulers”.
The causal agent pathogenesis immunological responses epidemiology diagnosis therapy and management of the disease as well as control and preventive efforts are all included in this review of the literature.
A Comparative Study on Approval of Follow-on Version of Sevelamer Carbonate and Glatiramer Acetate (GA) in US, EU
Many non-biological drugs different in terms of their structure and mode of action pharmacological classification and therapeutic indication have a common factor of structural complexity and are grouped as non-biological complex drugs (NBCDs). When an innovator drug nears the time of off-patent different manufacturers attempt to produce its subsequent version so the patients will have a cost-effective therapeutic equivalent. Since the innovator molecule is complex its follow-on drug can be called its true generic version if its bioavailability bioequivalence and therapeutic equivalence to the innovator drug are demonstrated. However it is observed that a case-to-case basis approach is implemented by European Medicines Agency (EMA) and Food and Drug Administration US (USFDA) in the approval of such drugs and there is no uniformity observed between the two.
In this study an attempt is made to study the complexity of molecules compare and understand the data requirements and procedures adopted for the review and approval of such complex products. Therefore drug sevelamer carbonate and glatiramer acetate are selected for the study. A methodical approach was followed. European assessment reports and drug approvals available in the orange book database of the former two regulatory agencies were studied. It is observed that the generic version of glatiramer acetate is approved as an abbreviated new drug application (ANDA) by Food and Drug Administration whereas the same was approved as the hybrid application by European Medicines Agency requiring the applicant to generate and submit more data. Thus harmonization of the regulatory requirements for the approval of follow-on versions of such complex drugs is essential for better understanding predictability of the regulatory process and acceleration of the drug approval process in the interest of patients. This will help the faster access of the drugs to the patients and allow interchangeability of the innovator drugs with its cost-effective generic version.
ACKNOWLEDGEMENTS TO REVIEWERS
Acknowledgements to Reviewers
Applied Drug Research, Clinical Trials and Regulatory Affairs
Applied Drug Research Clinical Trials and Regulatory Affairs is an international journal with vast readership and contributions that are scientific original relevant innovative and statistically validated. The journal aims to further bridge the gap in the publication of clinical drug development biotherapeutics and regulatory affairs between high growth and potentially growing regions.
The journal Applied Drug Research Clinical Trials and Regulatory Affairs publishes innovative developmental and original research on validated experimental design methods representation debates and interpretation of drug development research and drug research failures. The journal publishes original research articles full-length/mini reviews short communications and thematic journal issues. Published work is based on solid clinical scientific and statistically relevant results that lead to advancements in drug development for clinical medicine clinical trials post marketing drug reports drug delivery devices pharmaceutical engineering dissemination of trial results innovation regulatory affairs and human subject protection.
Applied Drug Research Clinical Trials and Regulatory Affairs is an international peer-reviewed journal on all aspects of drug research clinical trials and regulatory affairs published continuously (print & online) by Bentham Science Publishers.