Results 61 to 70 of about 1,008 (71)
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AAPS Journal
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used.
Qi Pei, Yang Guoping, Pei Qi
exaly +3 more sources
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used.
Qi Pei, Yang Guoping, Pei Qi
exaly +3 more sources
AAPS PharmSciTech
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM).
Anagha Damre, Aniruddha Banerjee
exaly +3 more sources
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM).
Anagha Damre, Aniruddha Banerjee
exaly +3 more sources
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report
AAPS Journal, 2018Sandra Suarez-Sharp +2 more
exaly