FDA Guidance for Industry: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
Titel:
FDA Guidance for Industry: The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for
new drug applications, or abbreviated new drug applications, and supplements to these applications,for oral drug product development, manufacturing changes, and controls