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,
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
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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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2013 White Paper on Recent Issues in Bioanalysis
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Biowaiver and Dissolution Profile Comparison
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2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
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2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization… by Society of Quality Assurance
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Comparison of EPA, FDA & OECD GLPs
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Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs
• orally inhaled drugs
• nasal sprays
• dermatological products
• antifungal creams and suppositories
• oral medications for oral candidiasis
• eye drops for conjunctivitis
• ear drops for external otitis
To Read the article, click on the below mentioned link…
Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs
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Comparison of BE guidelines as per various Regulatory Agencies
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2009 White Paper : Regulated Bioanalysis Workshop – Bioanalysis :: Canadian LC-MS Group
To view the article, click on the below link:
2009 White Paper : Regulated Bioanalysis Workshop – Bioanalysis :: Canadian LC-MS Group
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Amit Patel
M.Pharm-QA
Bioanalytical Research
Veeda Clinical Research Pvt. Ltd.
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