Biowaiver monographs for immediate relea
✍
S. Strauch; E. Jantratid; J.B. Dressman; H.E. Junginger; S. Kopp; K.K. Midha; V.
📂
Article
📅
2011
🏛
John Wiley and Sons
🌐
English
⚖ 148 KB
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