Biowaiver monographs for immediate release solid oral dosage forms: Mefloquine hydrochloride

• المؤلفون الرئيسيون: S. Strauch, E. Jantratid, J. B. Dressman, H. E. Junginger, S. Kopp, K. K. Midha, V. P. Shah, S. Stavchansky, D. M. Barends
• مؤلفون آخرون: Goethe-Universitat Frankfurt am Main
• التنسيق: مقال
• منشور في: 2018
• الموضوعات: Pharmacology, Toxicology and Pharmaceutics
• الوصول للمادة أونلاين: https://repository.li.mahidol.ac.th/handle/123456789/12833
• المؤسسة: Mahidol University

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing mefloquine hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. The solubility and permeability data of...