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A Textbook of Clinical Research and Pharmacovigilance

2021-11
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Release : 2021-11
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Kind : eBook
Book Rating : 518/5 ( reviews)

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Book Synopsis A Textbook of Clinical Research and Pharmacovigilance by : Kpr Chowdary

Download or read book A Textbook of Clinical Research and Pharmacovigilance written by Kpr Chowdary. This book was released on 2021-11. Available in PDF, EPUB and Kindle. Book excerpt: The book provides a comprehensive knowledge of various aspects such as drug development and approval process, pharmacological and toxicological approaches and methods, pharmaceutical dosage form approaches for drug development, clinical approaches and clinical trials, phases, types, designs and statistical tests of clinical trials, regulatory aspects, GCP as per ICH, WHO, ICMR, Schedule Y and regulatory environment in US, Europe and India in 20 chapters. Special emphasis is given to Pharmacovigilance methods and Pharmacovigilance programme of India (PvPI). The book provides a comprehensive knowledge of all aspects of clinical research, clinical trials, GCP guidelines and Pharmacovigilance as per the requirements of clinical research industry and personnel. The subject is presented in a simple, lucid and easily understandable way in logical flow for the benefit of pharmacy students as well as industry persons. Latest practices and regulatory guidelines are included and hence the book provides updated knowledge. This book is ideal for Pharm.D., M.Pharm, and PhD students of Pharmacy and also for research personnel involved in clinical research.

Clinical Research and Pharmacovigilance

2016-01-04
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Release : 2016-01-04
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Kind : eBook
Book Rating : 682/5 ( reviews)

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Book Synopsis Clinical Research and Pharmacovigilance by : Ravi Humbarwadi

Download or read book Clinical Research and Pharmacovigilance written by Ravi Humbarwadi. This book was released on 2016-01-04. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH & CLINICAL TRIALS1. NEW DRUG DEVELOPMENT2. HISTORICAL EVENTS3. GOOD CLINICAL PRACTICE - ICH GCP4. CLINICAL TRIAL DESIGN5. SERIOUS ADVERSE EVENT - SAE6. SITE7. PHARMACODYNAMICS8. PHARMACOKINETICS9. BIOAVAILABILITY10. BIOEQUIVALENCE11. QC AND QA IN CLINICAL TRIALS12. CLINICAL DATA MANAGEMENT13. PHARMACOVIGILANCE14. GIPV - ONLINEPHARMACOVIGILANCE1. INTRODUCTION2. NEED FOR PHARMACOVIGILANCE3. DEFINITIONS4. TYPES OF REPORTS5. REPORTING PROCESS6. SPONTANEOUS REPORTS7. TIME FRAMES FOR REGULATORY REPORTING8. CIOMS FORM9. MEDDRA10. MEDDRA - A PERSPECTIVE11. WHO DRUG DICTIONARYVE12. ACTION TAKEN, DC AND RC13. CAUSALITY ASSESSMENT14. UNBLINDING & SUSAR15. POST TREATMENT AND PRE-TREATMENT STUDY16. WORKFLOW17. THE PHARMACOVIGILANCE SYSTEM - EUDRAVIGILANCE.18. EMEA- GVP19. FDA: ADJUDICATION AND ADVISORY PANEL20. BACK TO THE FUTURE: VIOXX, MEDIATOR & THALIDOMIDE21. REGULATION AND DIRECTIVE ON PHARMACOVIGILANCE22. ASSESSMENT OF SERIOUSNESS FROM SOCIAL MEDIA23. SIGNAL DETECTION24. PROCESS OF SIGNAL DETECTION25. ARGUS 26. NARRATIVE WRITING - RULES & FORMAT27. IMPORTANT MEDICAL EVENT LIST28. GLOSSARY29. THE PHARMACOVIGILANCE INTERVIEW30. SERIOUS VS NON-SERIOUS: CASE STUDY & THUMB RULES

Drug Discovery and Clinical Research

2011-06 Medical
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Release : 2011-06
Genre : Medical
Kind : eBook
Book Rating : 724/5 ( reviews)

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Book Synopsis Drug Discovery and Clinical Research by : SK Gupta

Download or read book Drug Discovery and Clinical Research written by SK Gupta. This book was released on 2011-06. Available in PDF, EPUB and Kindle. Book excerpt: The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.

Textbook of Pharmacovigilance

2018-12-24 Medical
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Release : 2018-12-24
Genre : Medical
Kind : eBook
Book Rating : 034/5 ( reviews)

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Book Synopsis Textbook of Pharmacovigilance by : SK Gupta

Download or read book Textbook of Pharmacovigilance written by SK Gupta. This book was released on 2018-12-24. Available in PDF, EPUB and Kindle. Book excerpt:

An Introduction to Pharmacovigilance

2017-05-01 Medical
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Release : 2017-05-01
Genre : Medical
Kind : eBook
Book Rating : 742/5 ( reviews)

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Book Synopsis An Introduction to Pharmacovigilance by : Patrick Waller

Download or read book An Introduction to Pharmacovigilance written by Patrick Waller. This book was released on 2017-05-01. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

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