Which Is Better for FDA-Compliant Drug Analysis: Books or Websites?

AI Thread Summary
For FDA-compliant drug analysis, both books and websites can provide valuable resources, but the choice depends on the specific needs of the analysis. Existing drugs may be covered by pharmacopoeial methods, while new validations should reference ICH guidelines, particularly the Q2(r1) document. For physical chemistry testing, resources like the OECD website can be useful. The discussion emphasizes the importance of adhering to FDA rules and understanding drug attributes, such as the physical properties of tablets. Comprehensive references are essential for accurate analysis and compliance.
markone
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i need book or web for analysis ?

i need book or web for analysis drugs in standard way to make sure the drugs in rules FDA
and show detail about way and
analysis rules those drugs attributes (physic and chemitry)?
 
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markone said:
i need book or web for analysis drugs in standard way to make sure the drugs in rules FDA
and show detail about way and
analysis rules those drugs attributes (physic and chemitry)?

Are you using a translator? If so ... you need to find a better one.
 


Are you intending to characterise the drug compound or do you want to validate analytical methods to detect and quantify them?

Are they existing drugs? these may be covered by pharmacopoeial methods


For new validations I would consult ICH.org and their Q2(r1) validation document

For physical chemistry testing procedures consult http://www.oecd.org/document/48/0,3343,en_2649_34377_1916400_1_1_1_1,00.html
 


i am study analysis chemistry in drugs
like proportion Aspirin in every one Tablets
but should we know wish best way (analysis) we have use that way must be in rules (FDA)
and attributes physics like test (hardiness Tablets and crisp Tablets)

i need reference to know all about Tablets.......
 
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