Decision Points in Pharmaceutical Development

Decision Points in Pharmaceutical Development is organized by Pharmaceutical Education and Research Institute (PERI).

Initial Release Date: January 12, 2021
Expiration Date: December 31, 2024

Course Overview:
This introductory course focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights the decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support the initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is a discussion of how the development of a pharmaceutical candidate is a stepwise approach of learning, confirming and affirming that together with the product label drives the pharmaceutical development process.

Educational Objectives:

• Understand the pharmaceutical development process
• Describe each knowledge-based phase of the pharmaceutical development process
• Understand the importance of, and differences between, Learning Studies and Confirming Studies
• Define critical decision points in the pharmaceutical development process
• Utilize the questions and critical decision points to design a pharmaceutical development plan

Key Topics:

• History of Drug Regulation:  Who Regulates and Why Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach
• Critical Drug Development and Review Decision Points
• Successful and Failed Drug Development Programs