Drugs

PBPK Analyses Draft Guidance Out

FDA has published a draft guidance, The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls, with general recommendations for the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by IND sponsors and applicants for NDAs, ANDAs, and supplements to those applications for oral drug product development, manufacturing changes, and controls. The document says that PBPK analyses use models and simulations that combine physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic and/or pharmacodynamic behaviors of a drug product.

The guidance applies only to orally administered, systemically active drug products. It does not apply to locally acting drug products, including orally delivered gastrointestinal drug products that reach the site of action before entering systemic circulation.

Included in the guidance are Introduction, Background, Implementation of PBPK Modeling for Biopharmaceutics Applications, Development and Evaluation of PBPK models for biopharmaceutics applications, PBPK Modeling for Biopharmaceutics Applications to Support Product Quality, Glossary, and References.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome