Dissolution

AAPS_Annual_Guidance_Forum_Agenda_v1.pdf


BlueBackground_workshops-hero-size.jpg

Summary

The Chinese Pharmacopeia (ChP) has different requirements for dissolution testing than the US Pharmacopeia (USP), the European Pharmacopeia (EP), and the Japanese Pharmacopeia (JP), including:

  1. Testing approach and passing criteria for different stages is different: ChP requires a Q=85% while US is typically 80%
  2. Interpretation of the "Q" term for certain dosage forms is different
  3. No more than 12 dosage forms can be investigated

These differences can cause considerable retooling of methods and specifications when a company plans to release product in China.

This session will cover best practices, science-based approaches, and a rationale of ChP requirements.  We will also discuss strategies for partnering with our ChP colleagues to achieve quality, efficient, science-based approaches to meet our patient needs.

This session will also provide a forum to increase awareness and partnership with our global colleagues.  We will provide an opportunity to share preliminary survey findings on this issue as well as hear your feedback and concerns.

Learning Objective:

  1. Become aware of ChP requirements
  2. Learn how to address these requirements
  3. Develop dissolution design strategy
  4. Establish a forum to discuss such issues
  5. Enhance international harmonization 

Programming Committee

Mark Alasandro, Ph.D., MZA Pharmaceutical Consulting

Vivian Gray, Ph.D., V. A. Gray Consulting, Inc.

Bing Gu, Ph.D., Vertex

Xujin Lu, Ph.D, Bristol Myers Squibb

Yan Wu, Ph.D., University of North Carolina

Registration

 

All Sessions

Single Session

Member

$295

$150

NonMember

$395

$200

Student/Post Doc Member

$95

$50

All registrants will have access to the session slides and recordings post-event.

Group Registration
Bring four or more paid, full-conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g. speaker rate, complimentary sponsor passes, student rates, etc.). Email meetings@aaps.org for your discount code. The deadline to redeem is August 10, 2022.  f your group does not meet the minimum requirement, AAPS reserves the right to alter your registration fee.

Cancellation & Refund Policy

Cancellations must be submitted in writing to membership@aaps.org and will be honored as follows:

AAPS will issue a refund to any attendee who cancels at least three (3) business days in advance of the event:

  • Registrations cancelled on/before August 10, 2022, will be refunded registration fees minus an administrative fee of $50 for members/non-members or $25 for students.
  • In the case of a multi-day event, cancellations must be received no later than 3 business days before the first scheduled webinar date/start time.
  • Cancellations received less than 3 business days before the scheduled event date/start time will not be refunded.
  • In the rare event that AAPS must cancel due to circumstances beyond its control, AAPS will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another virtual event or to obtain a full refund.

No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the virtual event. If a technical failure at an individual’s home or workplace prevents access to the live event, they are not eligible for a refund. If the technical problem is due to AAPS’ error, AAPS will issue a refund.