Bioequivalence and IVIVC

    4 – 5 October 2021, online training

    Summary

    This unique 2-day online training course integrates the pharmacokinetics and biostudies as related to solid dosage formulations.

    Who should attend?

    BA/BE managers, R&D managers, Pharmacokinetics scientists, IVIVC specialists, Formulation managers, Solid dosage formulators, Regulatory affairs managers

    Learning Objectives

    • How to design a bioequivalence study
    • The statistical design needed to get regulatory approval
    • Connecting the dissolution data to pharmacokinetics
    • The predictive power of pilot studies
    • The requirements for studies in fasting and fed state
    • Validation and compliance issues
    • What is the relationship between formulation and bioavailability?
    • What to look for when auditing a biostudy house in terms of validation
    • Project management of biostudies

    Key Topics

    • General Requirements for Biostudies
    • Establishing the Biostudy Statistical Design
    • Similarity, Comparability, and Correlation
    • Predictive Power of Dissolution and Alternatives to Full BE
    • Validation and Compliance Issues

    Trainers

    Dynakin, Senior Associate
    Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is doctor in Pharmacy by the University of Navarra with a PhD in cardiovascular pharmacology.
    Online Participation
    1 450 Price incl. VAT: 1 450

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details