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
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
Android App of Amit Patel’s Blog (Bioanalysis)
11/03/2016 — Dr. AMIT PATELTo download our android mobile app (Amit Patel’s Blog (Bioanalysis)) , click on the below link and access the blogs from your palm.
REGARDS,
M.Pharm (QA)
Associate Research Scientist
Bioanalytical Development
Pharmaceutical Technology Center
Cadila Healthcare Ltd.
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â https://in.linkedin.com/in/amitpatel745
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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis
26/12/2014 — Dr. AMIT PATEL
To read the article, click on the below mentioned link…
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis
REGARDS,
M.Pharm (QA)
Sr. Research Associate
Bioanalytical Development
Pharmaceutical Technology Center
Cadila Healthcare Ltd.
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â https://in.linkedin.com/in/amitpatel745
================================================================================================
2013 White Paper on Recent Issues in Bioanalysis
26/12/2014 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
2013 White Paper on Recent Issues in BioanalysisÂ
REGARDS,
M.Pharm (QA)
Sr. Research Associate
Bioanalytical Development
Pharmaceutical Technology Center
Cadila Healthcare Ltd.
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â https://in.linkedin.com/in/amitpatel745
================================================================================================
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:Â amitpatel745@yahoo.com
Linkedin:Â http://in.linkedin.com/in/amitpatel745
===================================================================
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
20/10/2012 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â http://in.linkedin.com/in/amitpatel745
==================================================================
2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
20/10/2012 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â http://in.linkedin.com/in/amitpatel745
===================================================================
Recommendations on: IS Criteria, Stability, ISR & Recent 483s by GCC for Bioanalysis
23/06/2011 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â http://in.linkedin.com/in/amitpatel745
========================================================
Incurred Sample Reanalysis (ISR):- A Matter of Good Practises in Bioanalysis
22/05/2011 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
Incurred Sample Reanalysis (ISR):- A Matter of Good Practises in Bioanalysis
REGARDS,
M.Pharm (Q.A.)
Sr. Research Associate
Bioanalytical Development
Zydus Cadila
Ahmedabad.
Mobile: +91-9898758004
E-mail:Â amitpatel745@yahoo.com
Linkedin:Â http://in.linkedin.com/in/amitpatel745
========================================================
2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization
27/02/2011 — Dr. AMIT PATELTo read the article, click on the below mentioned link…
2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization… by Society of Quality Assurance
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
 ====================================================================
Comparison of EPA, FDA & OECD GLPs
27/02/2011 — Dr. AMIT PATELTo read the article, click on below mentioned link…
Comparison of EPA, FDA & OECD GLPs
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
 ====================================================================
Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs
27/02/2011 — Dr. AMIT PATELDemonstrating 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
Â
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
 ====================================================================
Mass Spectrometry – Methods & Theory
17/02/2011 — Dr. AMIT PATELTo view the presentation, click on the below mentioned link.
Mass Spectrometry –Â Methods & Theory
Â
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
 ====================================================================
Mass Analyzers with Theory, Pros-Cons & Applications
17/02/2011 — Dr. AMIT PATELMass Analyzers with Theory, Pros-Cons & Applications
SINGLE MS
Quadrupole
Ion Trap
Time of Filght
Magnetic Sector
Fourier Transform
Tandem MS
Triple Quadrupole
Quadrupole-Time of Flight
To View the document, click on the link mentioned below.
Mass Analyzers with Theory, Pros-Cons & Applications
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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
 ====================================================================
2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance
29/01/2011 — Dr. AMIT PATELTo read the article, click on the below 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
 ====================================================================
Comparison between BIOEQUIVALENCE requirements according to various Regulatory Agencies
29/12/2010 — Dr. AMIT PATELTo read the article, click on the below mentioned link.
Comparison of BE guidelines as per various Regulatory Agencies
Â
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
 ====================================================================
BASIC FUNDAMENTALS OF TANDEM MASS SPECTROMETRY
05/11/2010 — Dr. AMIT PATELTo view, click on the below link:
BASIC FUNDAMENTALS OF TANDEM MASS SPECTROMETRY
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
Â
===============================================================
IUPAC Standard Definitions of Terms relating to Mass Spectrometry
11/10/2010 — Dr. AMIT PATELTo View Mass Spectrometry Terms, Click on Link below:
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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
Â
=======================================================
2009 White Paper : Regulated Bioanalysis Workshop – Bioanalysis
26/09/2010 — Dr. AMIT PATEL2009 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
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
Â
==================================================================
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