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Basic Principles of Clinical Research and Methodology

Basic Principles of Clinical Research and Methodology (Hardcover)

By Gupta 
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Publisher: JPB
Edition: Hardcover
Edition Number: 1
Language: English
ISBN: 8184480865
EAN: 9788184480863
No. of Pages: 516
Publish Date: 2009-1-1
Binding: Hardcover
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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
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Specification

Title: Basic Principles of Clinical Research and Methodology
Publisher: JPB
Author: Gupta
Edition: Hardcover
Edition Number: 1
Language: English
ISBN: 8184480865
EAN: 9788184480863
No. of Pages: 516
Publish Date: 2009-1-1
Binding: Hardcover

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