Basic Principles of Clinical Research and Methodology (Hardcover)




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Basic Principles of Clinical Research and Methodology Book Description

Table of Contents

  • Clinical Research??'Past, Present and Future

  • Drug Development and Discovery

  • Designing Clinical Trials

  • Ethical Issues in Clinical Research

  • ICH-GCP Guidelines

  • Informed Consent Process: Protecting Subjects Rights

  • Role of CRC and CRA in Clinical Trials

  • Protocol Designing

  • Sponsor'''s and Investigator'''s Responsibilities

  • Patient Recruitment and Retention in Clinical Trials

  • Project Management in Clinical Trials

  • Pharmacovigilance in Clinical Research

  • Role of Contract Research Organization in Clinical Research Management

  • Outsourcing Clinical Research

  • Biostatistics in Clinical Trials

  • Bioequivalence Studies in Drug Development

  • Finance and Budgeting in Clinical Trials

  • Clinical Data Management

  • Clinical Trials for Herbal Drugs and Traditional Medicines

  • Investigational New Drug Applications

  • Case Report Form

  • Clinical Trial Logs

  • Standard Operating Procedures

  • Audits and Inspections in Clinical Trials

  • Fraud and Misconduct in Clinical Research

  • An Introduction to Medical Writing

  • Communication Skills

  • Requirements and Guidelines to Undertake Clinical Trials in India Schedule Y (Amended Version)

  • APPENDIX I: Data to be Submitted along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in the Country

  • APPENDIX I-A: Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in the Country

  • Index

Book Details

Title: Basic Principles of Clinical Research and Methodology
Publisher: JPB
Author: Gupta
Edition: Hardcover 1/e
Edition Number: 1
Language: English




No. of Pages: 516
Deliverable Countries: This product ships to India, Sri Lanka.

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Basic Principles of Clinical research and methodology by S K Gupta 0 Jun 19, 2009 7:42:14 PM
Kids Carnival
The book Basic Principles of Clinical Research and Methodology by Gupta (author) is published or distributed by JPB [8184480865, 9788184480863]. This particular edition was published on or around 2009-1-1 date. Basic Principles of Clinical Research and Methodology has Hardcover binding and this format has 516 number of pages of content for use. The printed edition number of this book is 1. This book by Gupta is written in English language.
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