This course will cover the application and basic elements of the theory of statistical methods in clinical pharmacology. The course will first concentrate upon the techniques used in the assessment of bioequivalence - the study of a drug formulation to confirm its equivalence to another.
The second day will cover newer approaches, scaled average bioequivalence and the developing field of biosimilars, and will touch upon the use of statistics in clinical pharmacology studies of safety and lot consistency studies in Vaccines. The emphasis will be on study design, analysis, and interpretation of data using real-data examples from the authors' experiences.
The course will provide attendees with: (1) a wide range of real examples with datasets, SAS® and R code (from the website accompanying the textbook), (2) applications of statistics in clinical pharmacology drug development with an emphasis upon regulatory applications, and (3) a detailed consideration of the statistical analysis and design of bioequivalence, biosimilarity, and clinical pharmacology studies.
Day 1 of the course will cover:
- 8:30-10: Biopharmaceutical Development and Clinical Pharmacology (Scott)
- 10:20-11:50: History and Regulation of Bioequivalence (Scott)
- 1:10-2:40: Testing for Average Bioequivalence (Byron)
- 3-4:30: Sample size re-estimation in Average Bioequivalence studies (Byron)
The addition of the section on biosimilarity represents significant new material since the first (and second) approvals of biosimilar products. Biosimilars are biologics that are highly similar to an approved reference product which are shown not to differ meaningfully in safety and efficacy from the approved product.
Day 2 of the course will cover:
- 8:30-10: Scaled Average Bioequivalence (Scott)
- 10:20-11:50: Biosimilarity (Johanna)
- 1:10-2:40: Lot Consistency Studies in Vaccines (Scott)
- 3-4:30: Clinical Pharmacology Safety Studies (Byron)