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GCP and Clinical Research: A Managerial Approach

Umesh C. Gupta

ISBN 10: 8130917769 / ISBN 13: 9788130917764
Published by Viva Books, 2011
New Condition: New Hardcover
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Clinical research in India has grown at an unprecedented rate in the last few years opening many new opportunities. At the same time, especially being a part of global clinical trials, it has put serious challenges for the compliance of trial conduct and validity and integrity of clinical trial data. Towards contributing to the corporate goals of established and emerging CROs and pharmaceutical firms, regarding research, innovation, profitability, and long-term sustainable growth, clinical research domain has become highly regulated and complicated requiring sound knowledge, project management skills and aspirations to achieve compliance with domestic and international regulations as well as towards achieving competitive, quality, compliance, cost and time benefits. This book, an a next-generation book, with plenty of tables, figures, and flow charts has been written with a purpose to satisfy the above unmet need and provides a quality pathway for conducting clinical trials. Contents: List of Abbreviations ? Chapter 1: Introduction to Clinical Research ? Clinical Trial: Definition ? Significance of Clinical Trials ? Sponsor and Site for Clinical Trial ? Regulations Governing Clinical Trials ? Ethics Committee in Clinical Trials ? Risks Involved in Clinical Trials ? Benefits of Clinical Trials ? Participants in Clinical Trials ? Conducting a Clinical Trial ? After the Completion of a Clinical Trial ? Types of Clinical Trials ? New Drug Development Process ? Clinical Development of a New Drug ? Phase I Trials (Human Pharmacology Trials or First in Human Studies) ? Types of Phase I: Trials ? Single Ascending Dose (SAD) Studies ? Multiple Ascending Dose (MAD) Studies ? Food Effect ? Phase II: Trials (Therapeutic Exploratory Trials or Proof of Concept) ? Phase III: Trials (Therapeutic Confirmatory Trials) ? Phase IV: Trials (Post-Marketing Trials) ? Clinical Trials in India ? India ? An Ideal Destination for Clinical Trials ? Challenges in India ? Appendix I: History of Research in Humans: Genesis of Regulations ? Appendix II: International Conference on Hormonization ? Appendix III: ICH Guidelines ? Appendix IV: ICH Efficacy Topics ? Chapter 2: ICH-GCP versus Indian GCP ? Differences in Glossary of terms/definitions ? ICH-GCP versus Indian GCP ? A Glimpse ? IRB/IEC Composition ? Documents for IRB/IEC Submission ? Documents to be Obtained from IRB/IEC ? Essential Documents for the Conduct of a Clinical Trial ? Before the Clinical Phase of the Trial Commences ? During the Clinical Conduct of the Trial ? After Completion or Termination of the Trial ? Chapter 3: Clinical Trial Framework ? Flowchart 1: Clinical Project Assessment ? Flowchart 2: Clinical Project Planning ? Flowchart 3: Prerequisites for the Study ? Flowchart 4: Study Design ? Flowchart 5: Clinical Trial QA-QC System ? Flowchart 6: Management of IP and IP-Related Documents ? Flowchart 7: Compensation for Subject?s Participation ? Flowchart 8: IRB/IEC Decision-making Process ? Flowchart 9: Selection of Contract Research Organization (CRO) ? Flowchart 10: Investigator and Site Selection ? Flowchart 11: Subject Recruitment Procedure ? Flowchart 11A: Therapeutic Trial ? Flowchart 11B: Non-Therapeutic Trial ? Flowchart 11C: Pregnant or Nursing Women as Research Subject ? Flowchart 11D: Children as Research Subject ? Flowchart 11E: Vulnerable Subjects as Research Subject ? Flowchart 12: Screening and Trial Procedures Initiation ? Flowchart 13: Clinical Trial Monitoring ? Flowchart 14: Ongoing Safety Evaluation and New Safety Information ? Flowchart 15: Safety Reporting ? Flowchart 16: Safety Updates Reports and Trial Progress Reports ? Flowchart 17: Deviation/Non-Compliance on the Part of Investigator ? Flowchart 18: Modifications/Amendments in the Study Protocol ? Flowchart 19: Premature Termination or Suspension of Clinical Trial ? Flow Printed Pages: 136. Bookseller Inventory # 35123

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Title: GCP and Clinical Research: A Managerial ...

Publisher: Viva Books

Publication Date: 2011

Binding: Hardcover

Book Condition:New

Edition: First edition.

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Brand New International Paper-back Edition Same as per description, **Economy edition, May have been printed in Asia with cover stating Not for sale in US. Legal to use despite any disclaimer on cover. Save Money. Contact us for any queries. Best Customer Support! All Orders shipped with Tracking Number

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