LIVE Online Course | 9am – 3pm CET
LIVE Online Course | 9am – 3pm CET
Learn how to successfully design, implement and report bioavailability and bioequivalence studies for different formulation types
Course Overview
Bioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation. Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation. Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier.
Through interactive sessions and multiple case studies, this course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. Once completed you will have a solid understanding of bioavailability, supporting you in drug development. You will also have the confidence to develop and implement your own bioequivalence studies to ensure speedy generic approval.
The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers and data needed so you can save money and time with fast biowaiver applications.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact felicity.bell@informa.com.
What will you learn?
Key Definitions
Understand the fundamentals of bioavailability, bioequivalence and biowaivers
BA/BE study
Determine when a BA/BE study is obligatory
BA/BE protocol studies
Identify the various BA/BE protocol studies that are used
Design Studies
Develop strategies for testing highly variable drugs and design studies for different types of formulation
Bioanalytical method validation and requirements
Examine bioanalytical method validation and requirements in the US and EU
Pharmacokinetic parameters calculation
Learn to calculate pharmacokinetic parameters on various types of studies and formulations
Bioequivalence regulations
- Assess the regulations in the EU, US, Russia, Brasil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance
Biowaiver regulations
Learn to interpret biowaiver regulations in the US and EU and meet compliance
Evaluation
Evaluating the risk associated with submitting a biowaiver
Who is this course for?
For professionals working in clinical drug development who formulate drugs. It is also a good course for those who work in QA in generic companies. Regulators would be interested due to BE data being used in variation applications.
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.