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Conference

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.


Timings

09:00 AM-06:00 PM (expected)
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Entry Fees

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Participants

100 - 500
Delegates
Based on previous editions

Category & Type

Conference
Medical & Pharma

Editions

Feb 2016


Frequency Not Available

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Organizer

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Drug Information Agency (dia)

USA52 Total Events / 1 Upcoming Event

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Bartolec Maja

Bartolec Maja

Zagreb, Croatia
Shivananda

Shivananda

Bengaluru, India
Momoko Chen

Momoko Chen

Marketing Director at Ledlink Optics,inc.

New Taipei, Taiwan

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Hahnstrase 9, 60528 Frankfurt am Main
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