Nuventra – Industry Resources & Links for Clinical Pharmacology, PK/PD

FDA Guidance Documents in Clinical Pharmacology & PK

Topic Link
Drug interaction studies (Feb 2012) – See also our page on DDI references  PDF
Hepatic impaired clinical pharmacology studies (May 2003)  PDF
Renal impaired clinical pharmacology studies (March 2010)  PDF
Exposure-Response Relationships (2003)  PDF
Pediatric PK Studies (1998)  PDF
Population PK (1999)  PDF
Bioavailability and Bioequivalence Studies for Oral Products (2003)  PDF
Statistical Approaches to Establishing Bioequivalence (2001)  PDF
Extended Release Oral Dosage Forms (1994)  PDF
Food Effect Studies (2002)  PDF

ICH Guidance Documents

Topic Link
Nonclinical Safety Studies to Support Human Clinical Trials And Marketing Authorization M3(R2) PDFConcept PaperPresentation

Drug-Drug Interaction References