By Anonymous on Friday, September 7, 2001 - 03:45 pm:
Hello folks, can any one please cite examples or give a web site address on how (i)Method Development procedure is attained for a drug or vitamin and (ii) Method Validation for a procedure.
Will highly appreciate any feedback.
Many regards to you all.
By Memerick on Monday, September 10, 2001 - 09:33 am:
There are quite a few Method Development procedures brought up in past discussion. My suggestion is to review the archives. There is one titled Methodology questions on May 25, 2001 that was rather good.
On the Method Validation, I would suggest reading the USP section on it.
By Vernon Shoup on Wednesday, November 28, 2001 - 06:07 am:
See the following documents from International Conference on Harmonization:
ICH Q2A (Guideline for Industry) Text on Validation of Analytical Procedures, March 1995
ICH Q2B Validation of Analytical Procedures: Methodology, November 1996
Also see the following documents from the FDA:
(Reviewer Guidance) Validation of Chromatographic Methods. November 1994
(Guidance for Industry; Draft) Analytical Procedures and Methods Validation; Chemistry, Manufacturing and Controls Documentation. August 2000.
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