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REGULATIONS OF CLINICAL TRIALS - By Rakesh Kuamr Rishi
 

Congratulation!! There was a need of such a book. I think you have covered almost all the points pertinent to Clinical Trials,. I wish more success for you. I will also ask my college library to purchase your book. If get the chance, I will also buy a copy of it.

Dr. S. Ziaur Rahman, Aligarh Muslim University


Congratulations for your great work. I find the contents most interesting.

Habeeb Ibrahim, GVK Biosciences Pvt. Ltd.

 

Price - Rs. 925/-

For overseas USD 50.00

 
No. of Pages - 350

 
Actual Size - 5.25” X 8.5”

 

 

This book on Regulation of Clinical Trials is a valuable compilation of benchmark national and international guidelines and statements relating to clinical research along with original chapters written by the author.

 

  • Regulation of Clinical Trials in India : An Introduction

  • Revised Schedule Y of Drugs and Cosmetics Rules

  • Rule 122 of Drugs and Cosmetics Act

  • Application Format for Undertaking Clinical Trial in India

  • Format for Fees Submission

  • Conditions for Import of Drugs for Examination, Test or Analysis

  • Conditions for Manufacture of Drugs for Examination, Test or Analysis

  • Stocking of Drugs

  • Indian GCP Guidelines

  • Guidelines for Bioavailability & Bioequivalence Studies

  • ICH Harmonised Tripartite Guideline -                    Guideline for Good Clinical Practice - E6(R1)

  • Data Safety Monitoring Board

  • Registrations of Clinical Trials

  • The Nuremberg Code

  • The Belmont Report

  • Clinical Research Organisations in India

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