Visualizing LIMS: How to Develop an RFP to Get the System You Want

A Request for Proposal can help a pharma lab to assess needs, draw a roadmap for the future, and get the LIMS system that it needs.

via Visualizing LIMS: How to Develop an RFP to Get the System You Want.

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

To view the article, click below metioned link…

aapsj0902014

 

REGARDS,

AMIT M. PATEL

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

Web: http://amitpatel745.topcities.com

 

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Review: Bioanalytical method validation – How, how much and why ?

Review: Bioanalytical method validation – How, how much and why ?

To view article, click on link mentioned below…

BMV-review

REGARDS,

AMIT M. PATEL

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.

Web: http://amitpatel745.topcities.com

 

 

 

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Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

 

Workshop/Conference Report —Quantitative Chromatographic Methods Validation and Implementation: Best Practices for Bioanalytical and Ligand Binding Assays 

The AAPS Journal 2007; 9 (1) Article 4 (http://www.aapsj.org). 

 To view the article, click on the link below. 

https://amitpatel745.files.wordpress.com/2010/05/aapsj0901004.pdf  

or  

aapsj0901004  

REGARDS,

 

AMIT M. PATEL

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.

Web: http://amitpatel745.topcities.com>

  

  

  

  

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Incurred Sample Reanalysis : Discussions

Incurred Sample Reanalysis : Discussions

European Bioanalysis Forum (EBF)’s Perspective and Experience

To View the Presentation: Click below link…

https://amitpatel745.files.wordpress.com/2010/05/isr.pdf

REGARDS,

Amit Patel

 

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Difference Between PURITY, ASSAY & POTENCY

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Difference Between PURITY, ASSAY & POTENCY

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Purity:

 

It is calculated by area normalisation method, it can be directly find out by chromatograms obtained from HPLC.

 

% Purity = (Area of desired peak / Sum of area of all peaks) x 100

 

Assay:

  

It is calculated against standard. It may be of following types:

 

1) On as is basis = (Area of sample / Area of standard) x (conc. of standard / conc. of sample) x potency or assay of standard

2) On anhydrous basis = (Assay on as is basis / 100 – moisture) x 100

3) On dried basis = (Assay on as is basis / 100 – LOD) x 100

 

Potency:

 

 100 – (moisture or LOD + residual solvents + heavy metals + sulphated ash + impurities)

 

 

REGARDS,

 

AMIT M. PATEL

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.

Web: http://amitpatel745.topcities.com

 

 

The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis

The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis REGARDS, AMIT M. PATEL 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. Web: http://amitpatel745.topcities.com

bio.10.36[1].pdf

Bioanalytical Method Validation: A Quality Assurance Auditor View Point

Bioanalytical Method Validation: A Quality Assurance Auditor View Point

RESEARCH METHODOLOGY

RESEARCH METHODOLOGY

Handbook of Good Clinical Practices (GCP)

Handbook of Good Clinical Practices (GCP)

HANDBOOK-GCP

STUDY MATERIALS FOR M.PHARM STUDENTS

Free Study Materials for M.Pharm Students:

Visit the site: http://amitpatel745.topcities.com

  

REGARDS,

Amit Patel

M.Pharm-QA

Bioanalytical Research

Veeda Clinical Research Pvt. Ltd.

http://amitpatel745.topcities.com

amitpatel745@yahoo.com

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Introduction to Mass Spectrometry