BA/BE & Biowaivers

Use in development, submission and post approval changes

Days
Hours
Minutes
Seconds
Online Live Stream

Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer
Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation
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!

Bioavailability bioequivalence and biowaivers online live training by Fleming Agenda Cover
Bioavailability bioequivalence and biowaivers online live training by Fleming Agenda Cover
Bioavailability bioequivalence and biowaivers online live training by Fleming Agenda Cover
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 as support of BE and biowaivers

Dissolution Setting specifications

Testimonials

Registration

Training ticket

Online Live Stream
FROM
1596
Delegate Fee
FROM
2396

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