The Importance of and Preparing the Target Product Profile (TPP)
Wednesday, March 6, 2024
12:15 PM – 1:15 PM East Coast USA Time
Location: Concourse B
The Target Product Profile (TPP), when completed as per FDA's former guidance, will provide the drug developer with the labeling concepts that are the goals of the drug development program, documents the specific studies that are intended to support the labeling concepts, and then will assist in a constructive dialogue with regulators. The TPP is a dynamic document, updated as often as (non-)clinical studies are completed and includes information from each discipline comprising an IND/NDA/BLA. Within each discipline, the TPP briefly summarizes the specific studies that will supply the evidence for each conclusion that is a labeling concept.
Typical key sections are: Indications and Usage, Dosage and Administration, Dosage Forms and Strengths, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Drug Abuse and Dependence, Overdosage, Description, Clinical Pharmacology, Nonclinical Toxicology, Clinical Studies, References, How Supplied/Storage and Handling, and Patient Counseling Information.
Learning Objectives:
Upon completion, participant will be able to understand the benefit of and need for a Target Product Profile.
Upon completion, participant will be able to prepare a Target Product Profile with input from functional area leads.
Upon completion, participant will be able to update a Target Product Profile with input from functional area leads.
