Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

Why Should You Attend:

It is the most critical test for establishing the quality of pharmaceutical products in particular tablet and capsule and is required by all major regulatory authorities and pharmacopeias. At present, industry and regulatory authorities face numerous challenges in conducting the test causing significant frustration to the authorities and industry.

This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. Discussion will be presented describing that the suggested bio-relevant method would become a QC method as well, avoiding the need for developing separate QC methods. Savings of significant human and financial resources will be highlighted.

Areas Covered in the Webinar:

• Overview of scientific inaccuracies and invalidities of current practices
• Describing the link of in vitro and in vivo dissolution and drug absorption
• Clarification of commonly misused terms (QC, bio-relevant, discriminatory testing etc.)
• Selecting experimental conditions (apparatus, medium, rpm, sink condition etc.)
• Introducing the crescent-shape spindle
• Description of an improved and vastly simple approach for testing

Who Will Benefit:

This webinar will provide valuable assistance to personnel working as bench chemist/analyst, supervisor, manager, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, in the following areas:

• Pharmaceutical Development
• Setting up Analytical Methods (Pharmacopeial, regulatory or in-house developed)
• R & D, both analytical and formulation
• Project Management
• Quality Control
• Quality Assurance
• Regulatory Affairs

Saeed Qureshi
Principal, PharmacoMechanics

Dr. Saeed Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. His areas of expertise include: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.

Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.

Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).

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