M10 BIOANALYTICAL METHOD VALIDATION | FDA

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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

https://amitpatel745.wordpress.com

ICH GUIDELINE ON BIOANALYTICAL METHOD VALIDATION M10 – 26Feb19

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

Android App of Amit Patel’s Blog (Bioanalysis)

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,

AMIT M. PATEL

M.Pharm (QA)

Associate Research Scientist

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Blogs: https://amitpatel745.wordpress.com

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

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Instrumentation and Application of LC-MS/MS in Bioanalysis

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,

AMIT M. PATEL

M.Pharm (QA)

Associate Research Scientist

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Blogs: https://amitpatel745.wordpress.com

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

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

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,

AMIT M. PATEL

M.Pharm (QA)

Associate Research Scientist

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Blogs: https://amitpatel745.wordpress.com

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

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis

 

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

 

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis

 

REGARDS,

AMIT M. PATEL

M.Pharm (QA)

Sr. Research Associate

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

 

2013 White Paper on Recent Issues in Bioanalysis

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

2013 White Paper on Recent Issues in Bioanalysis 

 

 

REGARDS,

AMIT M. PATEL

M.Pharm (QA)

Sr. Research Associate

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

Click on the below link to open the document.

USFDA-BMV (Draft)

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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Biowaiver & Dissolution Profile Comparison

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

Biowaiver and Dissolution Profile Comparison

 

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

Linkedin: 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)

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,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

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

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

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

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

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,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

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

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

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

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

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

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

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

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

2010 – Another Year of Bioanalytical Activity and Movement Towards Harmonization

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,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

Comparison of EPA, FDA & OECD GLPs

To read the article, click on below mentioned link…

Comparison of EPA, FDA & OECD GLPs

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs

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

 

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

Mass Spectrometry – Methods & Theory

To view the presentation, click on the below mentioned link.

Mass Spectrometry – Methods & Theory

 

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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Mass Analyzers with Theory, Pros-Cons & Applications

Mass 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

 

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

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

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

REGARDS,

AMIT M. PATEL

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

E-mail: amitpatel745@yahoo.com

Web: http://amitpatel745.topcities.com

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

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