Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union. [PDF]
García-Arieta A +4 more
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine
29812993In this monograph, the potential use of methods based on the Biopharmaceutics Classification System (BCS) framework to evaluate the bioequivalence of solid immediate-release (IR) oral dosage forms containing fexofenadine hydrochloride as a ...
Langguth, Peter +11 more
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Foreign Comparator Drug Products, Manufacturing & Supply Chain Considerations for Otic, Ophthalmic, And Parenteral Solutions - Generic Drugs Perspective. [PDF]
Nana A +4 more
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The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA). [PDF]
Moeti L, Litedu M, Joubert J.
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Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary. [PDF]
Fang L +8 more
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Editorial: The practical implication of clinical pharmacokinetics in drug development, pharmaceutical analysis, and clinical research. [PDF]
Khan A, Ahmad L, Raza F, Khan SA, Ali T.
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Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies. [PDF]
Krajcar D +4 more
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Bioequivalence centres in Africa: current state and opportunities for growth. [PDF]
Ncube BM, Muthuri S, Ajose O, Kikwai L.
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Bioequivalence of a Generic Vortioxetine 20 mg Tablet in Healthy Mexican Volunteers Under Fasting Conditions. [PDF]
Cruz PC +5 more
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