Bioequivalence and IVIVC
WHY SHOULD YOU ATTEND?
How to design a bioequivalence study
The statistical design needed to get regulatory approval. Connecting the dissolution data to pharmacokinetics.
Apply statistics beyond compliance
Avoid errors in connecting the dissolution data to PK. Understand the value of statistics in biostudies.
Align method strategy with regulatory success
Predictive Power of Dissolution and Alternatives to Full BE. Master the project management of bioequivalence studies.
Prevent validation and compliance issues
What to look for when auditing a biostudy in terms of validation? Connect science with regulatory expectations.
OUR ONLINE TRAINING EXPERIENCE INCLUDES
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
The General Requirements for Biostudies
Fundamentals of pharmacokinetics, Pharmacokinetic variables, The regulatory demands for study design in bioequivalence guidelines, Narrow therapeutic index drugs
Establishing the Biostudy Statistical Design
Estimation of statistical power and size of study as related to the drug absorption variability. Sample size determination, Fasting/fed studies, Modified release.
Establishing the Biostudy Statistical Design Part II
Statistics with HVD(P)s and NTIDs: equivalence acceptance criterion based on variability of the reference. Estimation of variability and its uncertainty.
Similarity, Comparability and Correlation
Dissolution & IVIVC Guidelines. Challenges for in vitro representativeness. Absorption rate determination. Time scaling. Prediction of plasma concentrations. Development of IVIVC, applications of IVIVC.
The Predictive Power of Dissolution and Alternatives to Full BE
Pilot pK Studies, alternatives to Full BE, BCS biowaivers, biowaivers of additional strengths.
The validation of bioanalytical methods
The requirements of GMP and GCP as applied to bioequivalence
WHO IS THIS TRAINING FOR?
BA/BE Managers
R&D Managers
Pharmacokinetics Scientists
IVIVC Specialists
Formulation Managers
Solid Dosage Formulators
Regulatory Affairs Managers
Clinical Pharmacologists
KEY TOPICS
General Requirements for Biostudies
Similarity, Comparability, and Correlation
Development and Applications of IVIVC
Establishing the Biostudy Statistical Design
Dissolution and Alternatives to Full Bioequivalence Study
Validation and Compliance Issues
TRAINER
PAST PARTICIPANTS
Bioequivalence and IVIVC
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
