which are the guidelines for force degradation studies?
Answer Posted / praveen kumar_ipca
The ANVISA forced degradation study requirements have an expansion of forced degradation beyond the work already performed during the various stages of drug and formulation development. This differs from the approaches adopted by ICH, EMA & FDA guidelines.
Praveen Kumar
IPCA
Sr.Excurive
Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
what is the extinction coefficient for Indomethacin or at 319nm wave length.
what you do when compound having dwel wavelength?
how can I make the copper get white bye any salt or acit?
Did anybody have method for acetyl cysteine effervescnce tablet
why cone formation during dissolution?
what type of question will ask in the interview of lab chemist.
What is split ratio in Gc? Splitless? how requirr to select?
Why six unit used for precision?
How require to perform linearity as per ANVISA? What are the acceptance criteria?
in dissolution if one bowl got 70 percent 2nd bowl got 80 percent and 3rd bowl got 90 percent then how proceed?
if you have given a blank water how you analyse by general analytical techniques?
why multimedia dissolution require to do?
How can we calculate "confidence interval" in analytical method validation? Pl. explain with example.
How would you decide dissolution medium for NCE compound of class I drug
How do we fix the sample concentaryion in hplc method development?