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Bioequivalence and IVIVC
Bioequivalence and IVIVC

Course Description

This interactive 2-day online training course provides theoretical and practical insights into Pharmacokinetics, Bioequivalence studies, and biowaivers as related to solid dosage formulations.

  • General Requirements for Biostudies
  • Establishing the Biostudy Statistical Design
  • Similarity, Comparability, and Correlation
  • Predictive Power of Dissolution and Alternatives to Full BE
  • Validation and Compliance Issues
  • How to design a bioequivalence study
  • The statistical design needed to get regulatory approval
  • Connecting the dissolution data to pharmacokinetics
  • The predictive power of pilot studies
  • The requirements for studies in fasting and fed state
  • Validation and compliance issues
  • What is the relationship between formulation and bioavailability?
  • What to look for when auditing a biostudy house in terms of validation
  • Project management of biostudies

Bioequivalence and IVIVC

27 - 28 November 2024, Live Online Training
Regular price €1.650,00
Unit price
per 
Dr. Paula Muniz

Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. Paula has more than 15 years of experience within the pharmaceutical industry where she has worked on regulatory strategy, clinical study design and result evaluation in several indications for a NCE and a fixed dose combination for EMA and FDA submissions. Focusing on comparative bioavailability, in vivo in vitro relationships/correlations, and pragmatic application of regulatory requirements, she has participated in the development of numerous complex immediate and modified release drug products.

START TIMES

1:00 PM Vienna time

12:00 PM London time

7:00 AM New York time

4:00 AM Los Angeles time

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Course Description

This interactive 2-day online training course provides theoretical and practical insights into Pharmacokinetics, Bioequivalence studies, and biowaivers as related to solid dosage formulations.

  • General Requirements for Biostudies
  • Establishing the Biostudy Statistical Design
  • Similarity, Comparability, and Correlation
  • Predictive Power of Dissolution and Alternatives to Full BE
  • Validation and Compliance Issues
  • How to design a bioequivalence study
  • The statistical design needed to get regulatory approval
  • Connecting the dissolution data to pharmacokinetics
  • The predictive power of pilot studies
  • The requirements for studies in fasting and fed state
  • Validation and compliance issues
  • What is the relationship between formulation and bioavailability?
  • What to look for when auditing a biostudy house in terms of validation
  • Project management of biostudies

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Bioequivalence and IVIVC

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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