10times
Add a review
22 - 23 Feb 2016Cancelled 

Joint DIA/FIP Workshop on Dissolution Testing

Workshop
Dorint Hotel Frankfurt Niederrad, Frankfurt, GermanyGet Directions
SelectSelectSaveShare
AboutExhibitorsSpeakersReviewsDeals

Average post reach is 164999 users. Start networking today!

profile_pic

Post

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.

Average post reach is 164999 users. Start networking today!

profile_pic

Post

Timings

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

Entry Fees

Check Official Website

Estimated Turnout

100 - 500
Delegates
Based on previous editions

Event Type

Workshop

Editions

Feb 2016


Frequency Not Available

Official Links

WebsiteContacts


Report Error
Claim this event

Organizer

Logo

Queries about the event? Ask Organizer
EditionFeb 2016

How did you participate in this event?

Visitor
Exhibitor
Speaker

Followers [ Users who have shown interest for this Event ] Join Community Invite


Add Profile

Invite users with similar interest

View More

Write a Review

Add Your Review
50.0855528.632693

Venue Map & Directions

map of Dorint Hotel Frankfurt Niederrad

Hahnstrase 9, 60528 Frankfurt am Main
Germany

Get Directions

More Events in Frankfurt


All Events in Frankfurt

Selected