Date: 25-26 November, 2026
Location: Riyadh, KSA
Training Program Overview
These 2 days training workshop aims to provide participants with in-depth knowledge and understanding of two critical ICH guidelines: ICH M13 Part A, which outlines the design and conduct of bioequivalence studies for immediate-release oral dosage forms, and ICH M10, which covers bioanalytical method validation.
Outlines:
ICH M10 Guideline:
- General
- Method development
- Method validation: Full validation, Partial validation, Cross validation, Chromatography
- Reference standards
- Validation
- Study sample analysis: Incurred sample reanalysis (ISR), Partial and cross validation, Additional considerations, Documentation
ICH M13A Guideline:
- General principles in establishing bioequivalence (BE)
- Study design for pharmacokinetic endpoint BE studies
• Study population
• Study design
• Sample size for BE studies
• Test and comparator products
• Fasting and Fed study conditions
• Dose or strength to be studied
• Moieties to be measured
• Considerations for sampling schedule - Data analysis for non-replicate study design
• Considerations for the BE analysis population
• Presentation of data
• Statistical analysis
• BE criteria
• Multiple comparator and multiple test product studies
• Specific topics - Endogenous compounds
- Other immediate-release dosage forms
• Orally disintegrating tablets
• Chewable tablets
• Oral suspensions - Fixed dose combination
- pH-dependency
• Documentation
Trainer Profile:
Prof. Ziyad Binkhathlan is Professor of Pharmaceutics at the College of Pharmacy, King Saud University (KSU), Riyadh, Saudi Arabia. He previously served as Chair of the Department of Pharmaceutics and currently serves as the Bioequivalence Track Supervisor within KSU’s Drug Regulatory Fellowship Program. He is also an Associate Editor of the Saudi Pharmaceutical Journal (Springer Nature).
Professor Binkhathlan received his Ph.D. in Pharmaceutical Sciences from the University of Alberta, Canada, and has extensive experience spanning pharmaceutics, biopharmaceutics, pharmacokinetics, drug delivery, and pharmaceutical regulation. His teaching covers undergraduate and graduate courses in pharmacokinetics, biopharmaceutics, and advanced drug delivery systems.
Professor Binkhathlan has authored over 35 peer-reviewed publications, a book chapter, and patents in the fields of nanomedicine, pharmacokinetics, and drug delivery. He serves as a reviewer for many leading international pharmaceutical journals and has received multiple recognitions, including the 2026 Springer Nature Editor of Distinction Awards.
In addition to his academic activities, Professor Binkhathlan has extensive regulatory experience through his previous role as Consultant to the Drug Sector (Department of Product Evaluation – Division of Bioequivalence) at the Saudi Food and Drug Authority (SFDA). He subsequently served as Deputy Head of the Advisory Committee for Generic and Biosimilar Products and currently serves as a member of the Scientific Advisory Committee at the SFDA.
