Training Course
Syllabus:
Specifications for small-molecule drug products Webinar
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Mark Powell
Description:
Appropriate drug product specifications are essential in order to safeguard patients and to ensure that medicines will be effective. This webinar will provide guidance on writing specifications for small-molecule drug products, answering questions such as: "What tests are needed for different dosage forms?", "When can disintegration testing be used in place of dissolution?", "How should dissolution specifications be set?" and "How should drug-related impurities be controlled? Why Should you Attend:
The webinar will teach participants how to write specifications for chemical drug products that meet the requirements of regulatory reviewers.
Objectives of the Presentation:
The webinar will cover:
- Regulatory guidance (ICH, FDA, EMEA)
- Tests appropriate to different dosage forms
- Dissolution specifications for immediate-release, modified-release and extended-release drug products
- Dissolution specifications in the context of the biopharmaceutical classification system
- Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination
- Specifications for combination drug products
- The role of specifications in maximizing drug product stability
- Worked examples
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