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

Seminar Summary:

Appropriate drug product specifications are essential in order to safeguard patients and to ensure that medicines will be effective.  (see full course description)

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