Hello Viewers,
Please click on the below link to download the guidance.
Thanks & Regards,
Dr. Amit Patel
+91-9898758004
Hello Viewers,
Please click on the below link to download the guidance.
Thanks & Regards,
Dr. Amit Patel
+91-9898758004
Hello Viewers,
Found an article you may be interested in: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation
Regards,
Dr. Amit Patel
M.Pharm, Ph.D
M: +91-9898758004
Hello 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
FORMULATION AND ANALYTICAL DEVELOPMENT FOR LOW-DOSE ORAL DRUG PRODUCTS
By – Jack Zheng
Download your book from below links..
https://amitpatel745.files.wordpress.com/2018/10/1m4te3gdcl_vwoc-3rqxs3jrlf0robjcj.pdf
Or
https://drive.google.com/open?id=1M4tE3GdCL_VwOC-3Rqxs3jrlf0rOBJc
Thanks & Regards,
Dr. Amit Patel
M.Pharm, Ph.D.
+91-9898758004
Email: amitpatel745@yahoo.com
To download our android mobile app (Amit Patel’s Blog (Bioanalysis)) , click on the below link and access the blogs from your palm.
REGARDS,
Just click on the below mentioned link to view the presentation on Instrumentation and Application of LC-MS/MS in Bioanalysis.
A Presentation: Instrumentation and Application of LC-MS/MS in Bioanalysis
REGARDS,
To read the article, click on the below mentioned link…
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To read the article, click on the below mentioned link…
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis
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To read the article, click on the below mentioned link…
2013 White Paper on Recent Issues in BioanalysisÂ
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Click on the below link to open the document.
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Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline
To read the article, click on the above mentioned link…
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To read the article, click on the below mentioned link…
The EMA Bioanalytical Method Validation Guideline: Nov 12
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To read the article, click on the below mentioned link…
Biowaiver and Dissolution Profile Comparison
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To read the article, click on the below mentioned link…
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To read the article, click on the below mentioned link…
2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
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To read the article, click on the below mentioned link…
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To read the article, click on the below mentioned link…
How to Manage for No Incurred Samples Reanalysis (ISR) Failures
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To read the article, click on the below mentioned link…
Incurred Sample Reanalysis (ISR):- A Matter of Good Practises in Bioanalysis
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To read the article, click on the below mentioned link…
2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization… by Society of Quality Assurance
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