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Bioavailability and Bioequivalence

PTI
Course summary
2 days
English
City of London
Professional Training

Course description

Bioavailability and Bioequivalence

Bioavailability and Bioequivalence - A Pharma Training Course by PTI

Through interactive sessions and multiple case studies this 2-day course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting.

The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers, data needed and the risk associated with submitting a biowaiver. By the end of this course, participants will be able to:

  • Understand the fundamentals of bioavailability, bioequivalence and biowaivers
  • Understand if and when a BA/BE study is required
  • Identify the various BA/BE protocol studies currently used
  • Implement strategies for testing highly variable drugs
  • Design studies for different types of formulation
  • Examine bioanalytical method validation and requirements in the US and EU
  • Calculate pharmacokinetic parameters on various types of studies and formulations
  • Assess the regulations in the EU, US, Russia, Brasil, China and Japan for bioequivalence studies
  • Interpret biowaiver regulations in the US and EU and meet compliance
  • Evaluating the risk associated with submitting a biowaiver
  • Gain a global perspective and maintain compliance

Suitability - Who should attend?

This training programme is aimed at professionals specialising in Manufacturing operations within the pharma industry.

Course instructor bio

J-M. Cardot is professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. The research fields of his laboratory are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and in vitro-in vivo correlation J-M. Cardot was in Ciba-Geigy and Novartis in development departments in Basel and in Paris, from 1987 to 1999.

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Expenses

The cost of this training course is £1595 + VAT per participant, which covers tuition and course materials.

In-house Training

PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 4.7

Based on 12 reviews

Regulatory Affairs International Project Manager, Medac GmbH
(5)
The trainer was very experienced with many examples and encouraged time for questions.
Director, Northumbria Pharma
(5)
The trainer was very knowledgeable and had good presentation skills.
Regulatory Affairs Development Manager, Regivet BV
(5)
The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.
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Reviews
Course rating
(4.7)
Based on 12 reviews
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