BA/BE, Dissolution & Biowaivers

Days
Hours
Minutes
Seconds
online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This practical course provides an in-depth understanding of BABE design including all practical aspects related to bioavailability & bioequivalence.

The series of case studies & discussions will bring clarifications on the computation of PK parameters, use of different types of biowaivers & related regulatory and legal aspects. You will learn about the development of dissolution tests as well as how to achieve QA/QC compliance.

meet the training leader
Jean Michel Cardot | Fleming
Jean-Michel Cardot
Professor
Consultant SAS Borvo
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

B/A B/E Dissolution and Biowaivers online live training course
Bioequivalence Dissolution and Biowaivers Training Course Agenda Cover _Fleming
Bioequivalence Dissolution and Biowaivers Training Course Agenda Cover Fleming_
key training

Topics

Bioavailability and Bioequivalence

BABE design

Practical aspects

Computation of PK parameters-statistical analysis

Specific cases & legal aspects

Biowaiver principles

The use of different types of biowaivers

Regulatory & legal aspects of biowaivers

Development of dissolution tests

Dissolution & QA/QC compliance

Setting specifications

Registration

Training ticket

Online Live Stream
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