Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies
| Autor: | Bing V. Li, Haritha Mandula, Hoainhon Nguyen, Dale P. Conner, Nilufer Tampal, Hongling Zhang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Drug
medicine.medical_specialty media_common.quotation_subject Pharmaceutical Science Pharmacy Antineoplastic Agents Review Article Aquatic Science Pharmacology Bioequivalence Biopharmaceutics Drug Discovery Healthy volunteers Medicine Animals Drugs Generic Humans Medical physics Drug Approval Ecology Evolution Behavior and Systematics Pharmaceutical industry media_common Ecology business.industry United States Food and Drug Administration General Medicine Biopharmaceutics Classification System United States Therapeutic Equivalency Oncology drug business Agronomy and Crop Science |
| Popis: | Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) introduced by Amidon (1) and adopted by the FDA, presents opportunities to avoid conducting the bioequivalence studies in humans. This paper analyzes the application of the BCS approach by the generic pharmaceutical industry and the FDA to oncology drug products. To date, the FDA has granted BCS-based biowaivers for several drug products involving at least four different drug substances, used to treat cancer. Compared to in vivo BE studies, development of data to justify BCS waivers is considered somewhat easier, faster, and more cost effective. However, the FDA experience shows that the approval times for applications containing in vitro studies to support the BCS-based biowaivers are often as long as the applications containing in vivo BE studies, primarily because of inadequate information in the submissions. This paper deliberates some common causes for the delays in the approval of applications requesting BCS-based biowaivers for oncology drug products. Scientific considerations of conducting a non-BCS-based in vivo BE study for generic oncology drug products are also discussed. It is hoped that the information provided in our study would help the applicants to improve the quality of ANDA submissions in the future. |
| Databáze: | OpenAIRE |
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