Iswarya, S (2019) Carbamazepine – Protocol Development for Anda Submission under FDA. Masters thesis, RVS College of Pharmaceutical Sciences, Coimbatore.
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Abstract
A major effective strategy for lowering the cost of medication, and thereby reducing its contribution to total healthcare costs, has been the introduction in global markets of generic equivalents of brand-name drugs (innovator drugs). Assessment of “interchangeability” between the generic and the innovator product is carried out by a study of “in vivo equivalence” or “bioequivalence” (BE). Now, many research has been done in recent years to develop new and more effective approaches to the assessment of BE. Thus, high-quality generic drugs at reduced costs have become available in every corner of the globe. The BE study for new and generic products will be accepted through the approval of regulatory authorities. So, regulatory guidelines are necessary for conducting BE studies which have little differences as by country basis. Therefore, it is important to know the acceptance criteria for protocol design as per regulatory authority in BE study. Thus, comparison of regulatory requirements provides information for the safety and efficacy of the drug product. CRO optimize their protocol designs with the goal of reducing complexity and cost, improving feasibility, and gathering more meaningful clinical data. The protocol design have impact on study budgets and on study execution feasibility. Thus, protocol plays a vital role in clinical study. Carbamazepine is a narrow therapeutic drug which causes adverse effects due to small differences in the dose concentration. Thus, the protocol is important for the safety and efficacy of the drug Carbamazepine in the bioequivalence study.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261725655 |
| Uncontrolled Keywords: | Carbamazepine, FDA |
| Subjects: | PHARMACY > Pharmacology |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 04 May 2022 10:36 |
| Last Modified: | 04 May 2022 10:36 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19656 |
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