Joint DIA/FIP Workshop on Dissolution Testing

22 - 23 Feb 2016Cancelled 
Dorint Hotel Frankfurt Niederrad, Frankfurt, Germany
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Dissolution testing is an important tool from early development to life cycle management of a drug product. The implementation of Quality by Design (QbD) principles requires understanding of process parameters, product attributes and their impact on in-vitro dissolution and bioavailability. In early development, biorelevant dissolution/release testing, i.e. the evaluation of luminal behaviour of drug products in gastrointestinal lumen with in vitro methodologies, is useful for predictions of .. continue reading formulation and food effects on plasma levels. It is also utilised to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.Recent updates and case studies on these subjects will be discussed by scientists working in academia, industry and regulatory agencies from Europe, the US and Japan. Key sessions and topics include: Biorelevant Testing and Methodology Tools and Applications- Definitions/background for biorelevant testing- Update of a current relevant EU initiative (orbito project)- Preclinical and clinical applications- PBPK modellingQuality Control Applications- Quality by Design (QbD) applications; Real Time Release Testing (RTRT)- Discriminating methods and addressing process changes during life cycle of a drug productRegulatory Considerations- EU, FDA and Japanese regulatory perspectives on the role of dissolution testing in product design and controlThere will be a discussion and a chance for attendees to ask questions at the end of each session.


09:00 AM-06:00 PM (expected)
Not Verified

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100 - 500
Based on previous editions

Category & Type

Medical & Pharma


Feb 2016

Frequency Not Available

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Drug Information Agency (dia)

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Bartolec Maja

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Zagreb, Croatia


Bengaluru, India
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Momoko Chen

Marketing Director at Ledlink Optics,inc.

New Taipei, Taiwan

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