5.3 — Clinical Study Reports

Reports of absolute and relative bioavailability studies

Reports of comparative bioavailability and bioequivalence studies

Reports correlating in vitro dissolution to in vivo bioavailability

Validation reports for bioanalytical methods used in human studies

In vitro plasma protein binding studies using human plasma

Hepatic metabolism and drug interaction studies using human liver microsomes/hepatocytes

Studies using other human biomaterials (blood cells, tissues)

Single- and multiple-dose PK and initial tolerability studies in healthy volunteers

PK and tolerability studies in target patient population

PK studies evaluating intrinsic factors (age, sex, race, renal/hepatic impairment, genetic polymorphisms)

PK studies evaluating extrinsic factors (drug interactions, food, smoking)

Population pharmacokinetic analysis reports

PD and PK/PD studies in healthy subjects including biomarker evaluation

PD and PK/PD studies in patients including dose-response characterization

Full study reports for controlled clinical efficacy and safety trials (pivotal studies)

Reports of uncontrolled clinical studies contributing to safety/efficacy assessment

Integrated analyses, pooled analyses, and meta-analyses across multiple studies

Reports of other clinical studies (long-term safety, compassionate use, etc.)

Reports of post-marketing clinical experience if drug marketed in other regions

Individual case report forms and patient data listings for pivotal and key studies