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Bioequivalence, Dissolution & Biowaivers

Bioequivalence training

Bioequivalence Event Date 24th to 25th April, Location – Athens, Greece

Masterclass Overview of Bioequivalent Drugs & Dissolution Database

WHO SHOULD ATTEND BIOAVAILABILITY AND BIOEQUIVALENCE TRAINING?

  • BA/BE manager field should attend this training
  • Regulatory affairs professionals should attend this training
  • Pharmacokineticists should attend this training
  • Dissolution testing specialists should attend this training
  • IVIVC specialists should attend this training
  • Formulation managers should attend this training
  • Solid dosage formulators should attend this training

Key Topic of Bioequivalence, Dissolution & Biowaivers Training

  • Participants will know about development of dissolution tests and their biomimetic value in this training
  • Participants will know how rediction of drug substance pharmacokinetics works in this training
  • In this training participants will get an opportunity to know about consideration of pKa and sites of absorption
  • In this training participants will explore the concept of Design of a biomimetic dissolution test
  • In this training participants will know the value of iViV correlations – regulatory viewpoint
  • In this training participants will know about bio study results vs. statistical requirements
  • In this training participants will understand the use of dissolution studies to obtain bio waivers
  • In this training participants will understand the relationship between formulation and bioavailability

KEY TAKEAWAYS OF BIOEQUIVALENCE STUDY OF DRUGS MASTERCLASS

Understand Bioavailability of Drugs

  • How to design a bio-equivalence study
  • The statistical design needed to get regulatory approval
  • The role of dissolution studies in screening formulations and as a regulatory requirement
  • In vivo-In vitro correlation:connecting the dissolution data to pharmacokinetics

Learn About Bioequivalent Drugs

  • About the predictive power of pilot studies and fed state
  • How to develop dissolution tests and how to interpret them
  • About the use of dissolution studies to obtain bio waivers

Gain

  • An understanding of the relationship between formulation and bio availability
  • A fundamental knowledge of drug absorption and its effect on dissolution and pharmacokinetics
  • An appreciation of what to look for when auditing a bio study house in terms of validation
  • Project management skills in terms of timing and planning of bio studies

Registration Fee


€2496


Per Participant


About The Netherlands

Amsterdam is the Netherlands’ capital, known for its artistic heritage, elaborate canal system and narrow houses with gabled facades, legacies of the city’s 17th-century Golden Age.

Start Time

9:00 am

April 24, 2019

Finish Time

5:00 pm

April 25, 2019

Address

Athens, Greece

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