Discussion Overview
The discussion revolves around the best resources, either books or websites, for FDA-compliant drug analysis. Participants are seeking guidance on standard methods for analyzing drug attributes, including physical and chemical properties, in accordance with FDA regulations.
Discussion Character
- Exploratory
- Technical explanation
- Debate/contested
Main Points Raised
- One participant requests resources for drug analysis that comply with FDA rules, specifically looking for detailed methodologies and attributes related to physical and chemical properties.
- Another participant questions whether the inquiry is about characterizing drug compounds or validating analytical methods for detection and quantification.
- It is suggested that existing drugs may be covered by pharmacopoeial methods, implying a potential resource for analysis.
- A reference to ICH.org and their Q2(r1) validation document is proposed for new validations.
- A link to OECD documentation is provided for physical chemistry testing procedures.
- A participant mentions studying the analysis of drugs, specifically the proportion of Aspirin in tablets, and seeks references for understanding tablet attributes, including hardness and crispness.
Areas of Agreement / Disagreement
Participants have not reached a consensus on whether books or websites are better for drug analysis, and multiple perspectives on the types of resources needed remain present.
Contextual Notes
Some assumptions about the specific needs for drug analysis and the context of existing versus new drugs are not fully clarified. The discussion includes references to various resources but does not resolve which is definitively better for compliance with FDA standards.