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:
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.
