Results 191 to 200 of about 4,045,482 (205)
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European Journal of Pharmaceutics and Biopharmaceutics, 2020
This paper presented how to establish a clinically relevant specification (CRS) using in silico physiologically based pharmacokinetic (PBPK) modeling. Three different formulations of model drug products were used in the clinical studies in order to distinguish between bioequivalent (BE) batches from non-BE batches. A human PBPK model was constructed by
Takuya Miyano, Tsuyoshi Mikkaichi
exaly +3 more sources
This paper presented how to establish a clinically relevant specification (CRS) using in silico physiologically based pharmacokinetic (PBPK) modeling. Three different formulations of model drug products were used in the clinical studies in order to distinguish between bioequivalent (BE) batches from non-BE batches. A human PBPK model was constructed by
Takuya Miyano, Tsuyoshi Mikkaichi
exaly +3 more sources
European Journal of Pharmaceutics and Biopharmaceutics
Prodrugs with enzymatic activation requirements, such as the weakly basic biopharmaceutical classification system (BCS) class IV compound abiraterone acetate (ABA), face considerable bioequivalence (BE) risks owing to their pH-dependent solubility, food effects, and variable intestinal hydrolysis.
Jin Yang
exaly +3 more sources
Prodrugs with enzymatic activation requirements, such as the weakly basic biopharmaceutical classification system (BCS) class IV compound abiraterone acetate (ABA), face considerable bioequivalence (BE) risks owing to their pH-dependent solubility, food effects, and variable intestinal hydrolysis.
Jin Yang
exaly +3 more sources
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
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
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).
Aniruddha Banerjee, Anagha Damre
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).
Aniruddha Banerjee, Anagha Damre
exaly +3 more sources
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report
AAPS Journal, 2018 This publication summarizes the proceedings of day 3 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Specifically, this publication discusses the current approaches in building ...
Anna Nordmark +2 more
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