Introduction to Dissolution Method Development & Validation

Duration: 90 Minutes
This webinar is designed to assist in dissolution to design, develop, and validate dissolution methods. Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. The webinar uses the Method Lifecycle concept to address method requirements in the Analytical Target Profile, then proceeds through Method Design, Development and Understanding followed by Validation, and continues through method routine use and changes.
Dissolution Testing
Instructor: Gregory Martin
Product ID: 501478
Objectives of the Presentation
  • Learn about several different reasons for developing dissolution methods, and corresponding differences in the approaches
  • Learn strategies for selecting dissolution conditions, including medium, apparatus and time points
  • Understand why dissolution method validation is more complex than that for other methods
  • Learn about trending of results and change control
  • Pointers for proposing specifications
Why Should you Attend
Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. It can also be used for biowaivers, which may enable a formulation change or generic product to be introduced without expensive and time-consuming bioequivalence studies. Since dissolution procedures can be over discriminating, it is important to have an appropriate balance in developing a dissolution procedure.

Areas Covered
  • What is the purpose of the Dissolution Method?
  • Lifecycle Approach to Dissolution Method Development
  • Stage 1: Design, Development and Understanding
    • Design: Analytical Target Profile
    • Development Process: Solubility, Apparatus, Medium, Measurement
    • Understanding: Risk Assessment
  • Stage 2: Qualification of the Method
    • Protocol: Establishing Expectations
    • Execution
    • Qualification Report
  • Stage 3: Ongoing Performance Verification and Method Changes
    • Trending
    • Changes Control: SUPAC and Biowaivers
Who can Benefit
  • Chemists (Research, Quality Control, and CRO; Human, Veterinary or Generic) involved with dissolution method development or testing and their managers
  • Formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution
$375
Recorded Session for one participant
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  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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