Inspector:
Dr. Ziyad Binkhathlan is an Associate Professor at the College of Pharmacy, King Saud
University. He is currently the Chairman of the Department of Pharmaceutics. He has over 10
years of experience in pharmaceutical research especially in the fields of pharmaceutics and
pharmacokinetics. He teaches basic and advanced courses in pharmacokinetics. His research
activities focus on the design and development of nanotechnology products that can increase
solubility, modify the pharmacokinetic/tissue distribution pattern, reduce toxicity and increase the
efficacy of different therapeutic agents. He published 17 peer-reviewed research papers and a book
chapter. He also serves as a reviewer for several international journals including Molecular
Pharmaceutics, AAPS PharmSciTech, International Journal of Pharmaceutics, and others. Dr.
Binkhathlan worked for four years as a Consultant to the Drug Sector-Department of Product
Evaluation (Division of Bioequivalence) at the Saudi FDA. He also served as a member (and
currently as Deputy Head) of the Advisory Committee for Generic and Biosimilar Products at the
Saudi FDA.
Day 1: Fundamentals and Regulatory Framework
- Overview of the bioequivalence (BE) study designs: Parallel, crossover, and replicate
- Key considerations in conduction of the study and analytical methods
- Saudi FDA requirements for:
- Narrow therapeutic index (NTI) drugs
- Highly Variable Drugs
- Modified Release Products
- Dissolution testing and similarity of dissolution profiles
- Biopharmaceutical Classification System (BCS) and Waivers
- Overview of the BCS and its application in BE
- Criteria for BCS-based biowaivers under Saudi FDA guidelines
Day 2: Special Cases and Advanced Topics
- Complex generic products: Types and examples
- BE requirements for complex generic products
- Preparing a BE study report for submission to the Saudi FDA
- Common deficiencies and how to avoid them
- Future trends in BE studies
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