Hello Viewers,
Found an article you may be interested in: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation
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Dr. Amit Patel
M.Pharm, Ph.D
M: +91-9898758004
ICH GUIDELINE ON BIOANALYTICAL METHOD VALIDATION M10 – 26Feb19
28/02/2019 — Dr. AMIT PATELHello Viewers,
Let’s have a new updated ICH Guideline published on 26Feb19.
BIOANALYTICAL METHOD VALIDATION M10
To view or download, click on the link below.
https://drive.google.com/file/d/1hTD45X2xmPEc5KmwDrieWMQzzWmlM2Tb/view?usp=drivesdk
Thanks & Regards,
Dr. Amit Patel
M.Pharm, Ph.D.
+91-9898758004
Email: amitpatel745@yahoo.com
Guidance for Industry : Bioanalytical Method Validation (Draft – 2013)
17/09/2013 — Dr. AMIT PATELClick on the below link to open the document.
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail: amitpatel745@yahoo.com
Linkedin: http://in.linkedin.com/in/amitpatel745
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Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline
09/04/2013 — Dr. AMIT PATELRegulated bioanalysis status in Japan and notable points of the draft Japanese guideline
To read the article, click on the above mentioned link…
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail: amitpatel745@yahoo.com
Linkedin: http://in.linkedin.com/in/amitpatel745
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The EMA Bioanalytical Method Validation Guideline: Nov 12
09/04/2013 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
The EMA Bioanalytical Method Validation Guideline: Nov 12
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail: amitpatel745@yahoo.com
Linkedin: http://in.linkedin.com/in/amitpatel745
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Review: Bioanalytical method validation – How, how much and why ?
21/05/2010 — Dr. AMIT PATELReview: Bioanalytical method validation – How, how much and why ?
To view article, click on link mentioned below…
REGARDS,
M.Pharm (Q.A.)
Research Associate
Bioanalytical Research Dept.
Veeda Clinical Research Pvt. Ltd.
Shivalik Plaza – A, Near I.I.M.,
Ambawadi,
Ahmedabad-380015.
Mobile: +91-9898758004.
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