This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.
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.
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
Course Provider
Saeed Qureshi,
