Summary of Biopharmacology and Clinical Pharmacology

Question 1

Describe the Summary of Clinical Pharmacology (SCP) section?

Answer 1

The SCP is a critical analysis of clinical pharmacology components of filing and summarizes pharmacokinetics/pharmacodynamics results, interpretation, and clinical implications.

Question 2

Name at least three types of data that are included in the SCP to support a BLA or NDA

Answer 2

• Standard PK analyses and sources of variability, including but not limited to, single dose and repeated dose PK data
• Recommended dose and regimen justification (including dose-response or dose-safety assessments)
• In vitro metabolism data

Question 3

Outline a few special studies/data included in SCP to support a BLA

Answer 3

• Immunogenicity data for recombinant proteins or other biological products
• A dedicated QT study and the c-QTc analysis could be included in Section 4 of the SCP as a special study
• In vitro studies conducted to characterize the spectrum of microbiological activity of the drug

Question 4

List three examples of other documents that have to be prepared before or in parallel to the submission dossier.

Answer 4

Population PK report, exposure-response/exposure-safety report and drug-drug interaction study report(s)

Question 5

Name a few functions that clinical pharmacologists have to collaborate with to complete the SCP

Answer 5

Clinical, bioanalytical, PDRD