Journal of Clinical Trials and Regulations

Journal Information
EISSN : 2582-4422
Total articles ≅ 6
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Articles in this journal

Kiran Rameshbhai Dudhat
Journal of Clinical Trials and Regulations, Volume 4, pp 1-19; https://doi.org/10.46610/jctr.2022.v04i02.001

Abstract:
The Biopharmaceutical Classification System (BCS) has been used as a predictive method to evaluate potential formulation impacts on oral medication bioavailability in humans. The BCS can assist in the prediction of in vivo product performance and the construction of mechanistic models that enable formulation assessments through the generation of scenarios when used in conjunction with in vitro dissolution testing. The applicability of current human BCS standards has not yet been examined in dogs, which restricts its application in canine medication development. The BCS has had a significant impact on drug discovery, development, and regulation on a global scale and the BCS continues to receive much validation, discussion, and extension in the literature. Drug regulatory organizations from all across the world have fully deployed the BCS when establishing bioavailability/bio-equivalence requirements for the approval of oral drugs with instant release (IR). In this study, we examine the provisional BCS classification of the most popular medications sold worldwide and discuss the BCS scientific framework and its influence on regulatory exercise of oral medicinal products. Also mentioned is the Biopharmaceutical Drug Disposition Classification System and how it relates to the BCS.
Pranjali Chandrakar, Hemasri Velmurugan, Pugazhenthan T., Deepak Kumar Dash, Vaibhav Tripathi
Journal of Clinical Trials and Regulations, Volume 4, pp 1-6; https://doi.org/10.46610/jctr.2022.v04i01.001

Abstract:
Over these previous years, clinicians dealing with patients with COVID infection 2019 have discovered that the abundant inflammatory response induced by the virus serves as a significant cause of the acute respiratory distress syndrome (ARDS) and multi-organ dysfunction, which happen in majority of the lethal cases. Presently, there is not a single drug available as an approved and genuine medication for corona infection, in this sphere of time immunomodulatory agents has exhibited encouraging response against coronavirus infection. The initial finding that interleukin-6 (IL-6) levels are raised in serious COVID-19 and independently foresee the risk of developing ARDS and finally death, such results had centered the clinical investigations on this pro-incendiary and pleiotropic cytokine. Tocilizumab (TCZ) is humanized anti-interleukin 6 receptor monoclonal immunizer and has been endorsed for different rheumatological ailments. Currently, many steroids as they act as an immunomodulatory agent have shown fantastic therapeutic effects while used in COVID infected peoples, such clinical data advocated the application of tocilizumab to combat corona infection. Patients who were in life threatening condition because of COVID-19 initiated pneumonia developed hyper aggravation. This medication lessens the further decay of the patient caused because of agglomeration of lymphocytic cells and diminishes the degree of high CRP (C-responsive protein). Nevertheless, several clinical investigations have been in progress to ascertain the drug profile. So that TCZ may be used in COVID patients with optimal effectiveness associated with minimum risk of adverse events. In this article, we have tried to encompass all relevant information about the pharmacology of TCZ, which will surely help to understand clinical behaviour of the drug.
Carlo A. Piria
Journal of Clinical Trials and Regulations, Volume 3; https://doi.org/10.46610/jctr.2021.v03i02.005

Abstract:
The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.
Avisek Dutta, Anupam Banerjee, Sunil Chaudhry
Journal of Clinical Trials and Regulations, Volume 3; https://doi.org/10.46610/jctr.2021.v03i02.003

Abstract:
The pharmacist’s contribution will remain an important element in effective healthcare system. Pharmacists have a critical role in patient drug safety by contributing to the identification, documentation and reporting of adverse drug reactions. Pharmacists have key roles to play in establishing benefits and risks profile of a marketed medicine. Country level drug ADR monitoring and programs throughout the world differ in their way of collecting ICSR reports by healthcare professionals specially pharmacist. In contrast to North American continent countries like Canada or the US, where the majority of the reports come from licensed pharmacists, some European and Asian countries, such as UK, France, Ireland, Malaysia have the maximum contribution of ADR reports coming from practicing physicians.
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