Bioequivalency, In-Vitro and In-Vivo - Clinical Research Informer

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Bioequivalency

In-Vitro

In-Vivo

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Approaches to Pharmacokinetic Analysis.

Production

Production Bioavailability In-Vivo In-Vitro

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

Development

Development Drugs Bioavailability In-Vivo

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

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