Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
Dr. 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. Specifically: (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 the 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.
This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. The 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. Registrants are encouraged to submit their questions on the topic prior to the seminar.
Drug dissolution test 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. The webinar is designed to highlight the current difficulties in conducting the tests and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
Arguably, this webinar is the only currently available webinar/seminar which is based on scientifically valid rationales for evaluating dissolution characteristics of a given product. The webinar will explain how one may use a universal test/tester completely avoiding developing and validating any other product-dependent dissolution method.
- 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
Who Should Attend
Anyone 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