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Hi every one
Is it validation is required for bioanalytical method development.
if yes which guidelines we have to follow. Is this guidelines
(bioanalytical method validation) available in ICH or what. IF it is
there in ICH kindly give the details.
thanks in advance.
devisha.
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The following message was posted to: PharmPK
Dear Devisha,
FDA has nicely described the need for bioanalytical method validation
and
how to pursue the same: Kindly refer this link:
http://www.fda.gov/cder/guidance/4252fnl.htm
Guidance for Industry
Bioanalytical Method Validation
Hope this helps
Vijay V Upreti
PhD Candidate
Pharmacokinetics-Biopharmaceutics Laboratory
Dept. of Pharmaceutical Sciences
University of Maryland, School of Pharmacy
Rm S509, 20 Penn St., Baltimore, MD 21201
Voice: 410.706.7388; Fax: 410.706.5017
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The following message was posted to: PharmPK
Dear Devisha,
FDA has nicely described the need for bioanalytical method validation
and
how to pursue the same: Kindly refer this link:
http://www.fda.gov/cder/guidance/4252fnl.htm
Guidance for Industry
Bioanalytical Method Validation
Hope this helps
Vijay V Upreti
PhD Candidate
Pharmacokinetics-Biopharmaceutics Laboratory
Dept. of Pharmaceutical Sciences
University of Maryland, School of Pharmacy
Rm S509, 20 Penn St., Baltimore, MD 21201
Voice: 410.706.7388; Fax: 410.706.5017
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Dear Devisha..
The guidelines are already given on www.ich.org. folllow the method
validation ...
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