Key Topics:

• Introduction

• General requirements for biostudies

• A dissolution chemists view on drug absorption

• Establishing biostudy statistical design

• Developing dissolution tests-QA and setting specifications

• Similarity, comparability and correlation

• The predictive power of dissolution and alternatives to full bioequivalence

• Requirements of GMP and GCP as applied to Bioequivalence

Who should attend?

• BA/BE managers

• Regulatory affairs professionals 

• Pharmacokineticists

• Dissolution testing specialists 

• IVIVC specialists

• Formulation managers

• Solid dosage formulators

About the trainer:

Paula Muniz (MSc, PhD) is a Senior Associate within Dynakin’s Drug Modeling & Consulting (DMC) group. She is a doctor in Pharmacy by the U of Navarra with a PhD in cardiovascular pharmacology. She is also a MSc in Clinical Research by the U of Cardiff and MBA by the Barcelona School of Managment from de U Pompeu Fabra. Paula has more than 20 years of experience within pharmaceutical industry in an international setting 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 pharmaceutical alternatives for oral, inhalation and intramuscular routes.

Zahid Mir

Director Sales and Strategic Alliances for Asia Pacific and Middle East

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Tabea Ridtahler

Marketing and Communication Manager for Europe and Africa 

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