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| Category 2 |
Health: Pharmacy
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| Contact |
420 Highway #7 East, Box 82022
Richmond Hill, Ontario
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| Description |
Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify degradant species. The stress testing practices that companies use can vary significantly and can have a serious impact on the analytical methodology used throughout the industry.
The ICH guideline indicates that stress testing is designed to help, determine the intrinsic stability of the molecule by establishing degradation pathways in order to identify the likely degradation products and to validate the stability-indicating power of the analytical procedures used.
The goal of this one-day workshop is to provide delegates with clarity and advice on determining the correct stress conditions to use the most up to date and appropriate analytical methods, and deciding the best threshold levels of detection.
The topics covered during this course will include the followings:
Regulatory perspectives on drug degradation and stress testing
The Chemistry of Drug Degradation
Standard operating procedures and protocols on GMP issues
Current strategies and protocols for stress testing of pharmaceuticals and industry best practices
Experimental protocol for degradation studies of new drug substances and drug products
Stress Testing on Drug Substance and Drug Product – A Generic Approach
Stress Testing Study Design
Types of stress conditions and experimental approaches
Timing of stress testing (drug substance and drug product)
Utilization of Forced Degradation Studies in Formulation Development
Forced Degradation Studies to Develop a Stability Indicating HPLC Method
Packaging-induced and excipient-induced degradation
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