This specific ISBN edition is currently not available.View all copies of this ISBN edition:
BRAND NEW, Exactly same ISBN as listed, Please double check ISBN carefully before ordering.
"synopsis" may belong to another edition of this title.
Book Description Hardcover. Condition: New. Revised edition. Brand NEW, Paperback International Edition. Black & White or color, Cover and ISBN same with similar contents as US editions. Standard delivery takes 5-9 business days by USPS/DHL with tracking number. Choose expedited shipping for superfast delivery 3-5 business days by UPS/DHL/FEDEX. We also ship to PO Box addresses but by Standard delivery and shipping charges will be extra. International Edition Textbooks may bear a label -Not for sale in the U.S. or Canada- etc. printed only to discourage U.S. students from obtaining an affordable copy. Legal to use despite any disclaimer on cover as per US court. No access code or CD included unless specified. In some instances, the international textbooks may have different exercises at the end of the chapters. Printed in English. We may ship the books from multiple warehouses across the globe, including India depending upon the availability of inventory storage. In case of orders from Europe, custom charges may comply by the relevant government authority and we are not liable for it. 100% Customer satisfaction guaranteed! Please feel free to contact us for any queries. Seller Inventory # AB1453087
Book Description Viva Books - Originals, 2012. Hardcover. Condition: New. Seller Inventory # 635777
Book Description Paperback. Condition: New. New, Softcover International Edition, Printed in Black and White, Different ISBN, Same Content As US edition, Book Cover may be Different, in English Language. Seller Inventory # 30494
Book Description PAPERBACK. Condition: New. Book Cover and ISBN may be different from US edition but contents as same US Edition.We do not provide CD and access code. We may ship the books from Asian regions for inventory purpose. Our courier service is not available at APO FPO AND PO BOX. Seller Inventory # 79386
Book Description Condition: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Seller Inventory # AINDN-23870
Book Description Condition: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship fro the US or other locations in India depending on your location and availability. Seller Inventory # AUNEW-23870
Book Description VIVA BOOKS - ORIGINALS. Condition: New. Seller Inventory # AVS-9788130917764
Book Description Viva Books, 2011. Hardcover. Condition: New. First edition. 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. Seller Inventory # 35123
Book Description Condition: New. This is Brand NEW. Seller Inventory # SR-eCOMMERCE-21112018-39912
Book Description Viva Books. Hardcover. Condition: New. 8130917769. Seller Inventory # VU-11-6-9788130917764