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

Click For Summary
SUMMARY

The discussion centers on the need for resources to analyze drugs in compliance with FDA regulations, specifically focusing on physical and chemical attributes. Participants recommend consulting the ICH Q2(r1) validation document for new validations and suggest using pharmacopoeial methods for existing drugs. Additionally, the OECD document on physical chemistry testing procedures is highlighted as a valuable resource for understanding drug attributes such as tablet hardness and composition. Overall, the consensus is that both books and reputable websites can provide essential information for FDA-compliant drug analysis.

PREREQUISITES
  • Understanding of FDA regulations regarding drug analysis
  • Familiarity with ICH Q2(r1) validation guidelines
  • Knowledge of pharmacopoeial methods for drug testing
  • Basic principles of physical chemistry related to drug attributes
NEXT STEPS
  • Research the ICH Q2(r1) validation document for analytical method validation
  • Explore pharmacopoeial methods for existing drug analysis
  • Review the OECD guidelines on physical chemistry testing procedures
  • Investigate resources on tablet hardness testing and composition analysis
USEFUL FOR

This discussion is beneficial for pharmaceutical researchers, quality control analysts, and regulatory affairs professionals involved in FDA-compliant drug analysis and validation processes.

markone
Messages
17
Reaction score
0
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)?
 
Physics news on Phys.org


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.......
 

Similar threads

  • · Replies 12 ·
Replies
12
Views
2K
  • · Replies 15 ·
Replies
15
Views
2K
Replies
1
Views
3K
Replies
0
Views
928
  • · Replies 8 ·
Replies
8
Views
713
  • · Replies 11 ·
Replies
11
Views
3K
  • · Replies 6 ·
Replies
6
Views
3K
  • · Replies 17 ·
Replies
17
Views
5K
  • Sticky
  • · Replies 16 ·
Replies
16
Views
12K
  • · Replies 8 ·
Replies
8
Views
3K