OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING – NUMBER 22

21/09/2021 — Dr. AMIT PATEL

Hello Viewers,

Please click on the below link to download the guidance.

OECD Series on GLP Principles – 22Download

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Dr. Amit Patel

+91-9898758004

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M10 BIOANALYTICAL METHOD VALIDATION | FDA

01/07/2019 — Dr. AMIT PATEL

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

https://amitpatel745.wordpress.com

Posted in Analytical, Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , , , , . Leave a Comment »

ICH GUIDELINE ON BIOANALYTICAL METHOD VALIDATION M10 – 26Feb19

28/02/2019 — Dr. AMIT PATEL

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

Blogs: https://amitpatel745.wordpress.com

Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , , , . 1 Comment »

FORMULATION AND ANALYTICAL DEVELOPMENT FOR LOW-DOSE ORAL DRUG PRODUCTS

21/10/2018 — Dr. AMIT PATEL

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

Blogs: https://amitpatel745.wordpress.com

Posted in Analytical, Formulation, General, Pharmaceutics, Regulatory Affairs. Tags: , , . Leave a Comment »

Total Views & Visitors & Top 10 Countries… Since 2012.

08/06/2018 — Dr. AMIT PATEL

    Thanks & Regards,

    Dr. Amit Patel

    +91-9898758004

    https://www.amitpatel745.wordpress.com

    https://www.linkedin.com/in/amitpatel745

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    Android App of Amit Patel’s Blog (Bioanalysis)

    11/03/2016 — Dr. AMIT PATEL

    To download our android mobile app (Amit Patel’s Blog (Bioanalysis)) , click on the below link and access the blogs from your palm.

    Android Mobile App

    REGARDS,

    M.Pharm (QA)
    Associate Research Scientist
    Bioanalytical Development
    Pharmaceutical Technology Center
    Cadila Healthcare Ltd.
    Ahmedabad.
    Mobile: +91-9898758004
    ================================================================================================================

     

    Posted in Bioanalysis, Clinical Pharmacy, General, Medicinal Chemistry, Pharmaceutics, Pharmacology, Quality Assurance, Regulatory Affairs. Tags: . Leave a Comment »

    Instrumentation and Application of LC-MS/MS in Bioanalysis

    09/03/2016 — Dr. AMIT PATEL

    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,

    M.Pharm (QA)
    Associate Research Scientist
    Bioanalytical Development
    Pharmaceutical Technology Center
    Cadila Healthcare Ltd.
    Ahmedabad.
    Mobile: +91-9898758004
    ================================================================================================================

     

    Posted in Bioanalysis, General. Tags: , , , , , , , . Leave a Comment »

    Triple quadrupole linear ion trap mass spectrometer for the analysis of small molecules and macromolecules

    19/08/2015 — Dr. AMIT PATEL

    To read the article, click on the below mentioned link…

    Triple quadrupole linear ion trap mass spectrometer for the analysis of small molecules and macromolecules

    REGARDS,

    M.Pharm (QA)
    Associate Research Scientist
    Bioanalytical Development
    Pharmaceutical Technology Center
    Cadila Healthcare Ltd.
    Ahmedabad.
    Mobile: +91-9898758004

    ================================================================================================

    Posted in Bioanalysis, General. Tags: , , , . Leave a Comment »

    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

    ================================================================================================

     

    Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , , . Leave a Comment »

    2013 White Paper on Recent Issues in Bioanalysis

    26/12/2014 — Dr. AMIT PATEL

    To read the article, click on the below mentioned link…

    2013 White Paper on Recent Issues in Bioanalysis 

     

     

    REGARDS,

    M.Pharm (QA)
    Sr. Research Associate
    Bioanalytical Development
    Pharmaceutical Technology Center
    Cadila Healthcare Ltd.
    Ahmedabad.
    Mobile: +91-9898758004

    ================================================================================================

     

    Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , , . Leave a Comment »

    Guidance for Industry : Bioanalytical Method Validation (Draft – 2013)

    17/09/2013 — Dr. AMIT PATEL

    Click on the below link to open the document.

    USFDA-BMV (Draft)

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004
    Linkedin: http://in.linkedin.com/in/amitpatel745

    ===================================================================

    Posted in Bioanalysis, Clinical Pharmacy, General, Quality Assurance, Regulatory Affairs. Tags: , , . Leave a Comment »

    Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline

    09/04/2013 — Dr. AMIT PATEL

    Regulated 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
    Linkedin: http://in.linkedin.com/in/amitpatel745

    ========================================================

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    The EMA Bioanalytical Method Validation Guideline: Nov 12

    09/04/2013 — Dr. AMIT PATEL

    To 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
    Linkedin: http://in.linkedin.com/in/amitpatel745

    =========================================================

    Posted in General. Tags: , . 2 Comments »

    Biowaiver & Dissolution Profile Comparison

    18/02/2013 — Dr. AMIT PATEL

    To read the article, click on the below mentioned link…

    Biowaiver and Dissolution Profile Comparison

     

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004
    Linkedin: http://in.linkedin.com/in/amitpatel745

    ==============================================================

    Posted in Bioanalysis, General, Pharmaceutics, Regulatory Affairs. Tags: . Leave a Comment »

    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 PATEL

    To read the article, click on the below mentioned link…

    Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

     

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004
    Linkedin: http://in.linkedin.com/in/amitpatel745

    ==================================================================

    Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , . Leave a Comment »

    2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

    20/10/2012 — Dr. AMIT PATEL

    To 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
    Linkedin: http://in.linkedin.com/in/amitpatel745

    ===================================================================

    Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: , . 1 Comment »

    Recommendations on: IS Criteria, Stability, ISR & Recent 483s by GCC for Bioanalysis

    23/06/2011 — Dr. AMIT PATEL

    To read the article, click on the below mentioned link…

    Recommendations on: Internal Standard Criteria, Stability, ISR & Recent 483s by Global CRO Council for Bioanalysis

     

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004

    ========================================================

    Posted in Bioanalysis, Clinical Pharmacy, General, Quality Assurance, Regulatory Affairs. Tags: , , , , , , . Leave a Comment »

    How to Manage for No Incurred Samples Reanalysis (ISR) Failures

    22/05/2011 — Dr. AMIT PATEL

    To read the article, click on the below mentioned link…

    How to Manage for No Incurred Samples Reanalysis (ISR) Failures

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004

    ========================================================

    Posted in Bioanalysis, General. Tags: , , . Leave a Comment »

    Incurred Sample Reanalysis (ISR):- A Matter of Good Practises in Bioanalysis

    22/05/2011 — Dr. AMIT PATEL

    To 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

    ========================================================

    Posted in Bioanalysis, General, Quality Assurance. Tags: , , . Leave a Comment »

    2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization

    27/02/2011 — Dr. AMIT PATEL

    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

    REGARDS,

    M.Pharm (Q.A.)
    Sr. Research Associate
    Bioanalytical Development
    Zydus Cadila
    Ahmedabad.
    Mobile: +91-9898758004

     ====================================================================

    Posted in Bioanalysis, General, Quality Assurance, Regulatory Affairs. Tags: . Leave a Comment »
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