Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine

• المؤلفون الرئيسيون: E. Jantratid, S. Prakongpan, J. B. Dressman, G. L. Amidon, H. E. Junginger, K. K. Midha, D. M. Barends
• مؤلفون آخرون: Mahidol University
• التنسيق: Review
• منشور في: 2018
• الموضوعات: Pharmacology, Toxicology and Pharmaceutics
• الوصول للمادة أونلاين: https://repository.li.mahidol.ac.th/handle/123456789/23913

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned...