Dr. Amit Patel&#039;s Blogs&#8230;!!!

M.Pharm (QA)

Associate Research Scientist

Bioanalytical Development

Pharmaceutical Technology Center

Cadila Healthcare Ltd.

Ahmedabad.

Mobile: +91-9898758004

Blogs: https://amitpatel745.wordpress.com

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

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Posted in Bioanalysis, Clinical Pharmacy, General, Medicinal Chemistry, Pharmaceutics, Pharmacology, Quality Assurance, Regulatory Affairs. Tags: Android App. 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

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

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

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Posted in Bioanalysis, Clinical Pharmacy, General, Quality Assurance, Regulatory Affairs. Tags: Bioanalytical Method Validation, FDA, Regulated Bioanalysis. Leave a 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…

REGARDS,

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

Comparison of EPA, FDA & OECD GLPs

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Posted in Bioanalysis, Clinical Pharmacy, General, Quality Assurance, Regulatory Affairs. Tags: Bioanalysis 483s, Global CRO Council, Incurred Sample Reanalysis, Internal Standard, ISR, Regulated Bioanalysis, Stability. Leave a Comment »

Comparison of EPA, FDA & OECD GLPs

27/02/2011 — Dr. AMIT PATEL

To read the article, click on below mentioned link…

REGARDS,

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs

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Posted in Bioanalysis, Clinical Pharmacy, General, Pharmacology, Quality Assurance, Regulatory Affairs. Tags: EPA, FDA, GLP comparison, OECD. Leave a Comment »

Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs

27/02/2011 — Dr. AMIT PATEL

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…

REGARDS,

M.Pharm (Q.A.)

Sr. Research Associate

Bioanalytical Development

Zydus Cadila

Ahmedabad.

Mobile: +91-9898758004

Comparison of BE guidelines as per various Regulatory Agencies

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Posted in Bioanalysis, Clinical Pharmacy, General, Pharmacology, Quality Assurance, Regulatory Affairs. Tags: bioequivalence. 1 Comment »

Comparison between BIOEQUIVALENCE requirements according to various Regulatory Agencies

29/12/2010 — Dr. AMIT PATEL

To 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

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Posted in Bioanalysis, Clinical Pharmacy, General, Quality Assurance, Regulatory Affairs. Tags: BE comparison, BE Requirements, Regulatory Agencies. 3 Comments »

Procedural Elements Involved in Maintaining Bioanalytical Data Integrity for Good Laboratory Practices Studies and Regulated Clinical Studies

30/05/2010 — Dr. AMIT PATEL

To view the article, click below metioned link…

aapsj0902014

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