Compact Regs Parts 50 54 56 and 312

Author: Interpharm
Publisher: CRC Press
ISBN: 1482207982
Format: PDF, Docs
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This publication contains a verbatim reproduction of 21 CFR Part 50 Protection of Human Subjects, 21 CFR Part 54 Financial Disclosure by Clinical Investigators, 21 CFR Part 56 Institutional Review Boards & 21 CFR Part 312 Investigational New Drug Application.

Designing Clinical Research

Author: Stephen B. Hulley
Publisher: Lippincott Williams & Wilkins
ISBN: 1469840545
Format: PDF
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Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.

Clinical Dermatology Trials 101

Author: Adnan Nasir
Publisher: Springer
ISBN: 3319090275
Format: PDF, Mobi
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​​Clinical Dermatology Trials 101 provides dermatologists with a handbook that allows them to become familiar with all aspects of clinical trials. Everything from obtaining the necessary tools and equipment, complying with local, federal, and international guidelines and regulations, and hiring and training staff for the safe and up-to-date conduct of dermatology clinical trials is covered. Written by leading experts in the field, Clinical Dermatology Trials 101 is the only clinical trial how-to available for dermatologists. With skin disease affecting nearly seventy percent of the population over a lifetime, and the rate of development of new drugs and devices for dermatologic use increasing at an exponential rate, there is a tremendous need for training and developing dermatology clinical research facilities to expedite the translation of basic and applied research, from bench to bedside. This is useful for practicing dermatologists, academic dermatologists, dermatology residents, clinical research fellows, dermatology fellows, research scientists, industry dermatologists, and medical students.​

Biological Drug Products

Author: Wei Wang
Publisher: John Wiley & Sons
ISBN: 1118695224
Format: PDF, Kindle
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Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.

Handbook

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547553
Format: PDF, Kindle
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Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data. This handbook is designed as an aid for those countries wishing to upgrade their laboratories to GLP status. Based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP, The aim of the handbook is to provide laboratories and trainers in disease-endemic countries with the necessary technical information for implementing GLP programmes. The material in the handbook is presented in a clear and informative way. The introduction reviews the need for quality standards in drug research and development, and gives a history of GLP. Chapter 2 covers GLP training, and chapter 3, The stepwise introduction of GLP. The OECD principles of GLP and compliance monitoring are reprinted, with kind permission, In the annex section

Institutional Review Board Management and Function

Author: Elizabeth A. Bankert
Publisher: Jones & Bartlett Learning
ISBN: 9780763730499
Format: PDF, Kindle
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This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.

Handbook of Drug Nutrient Interactions

Author: Joseph I. Boullata
Publisher: Springer Science & Business Media
ISBN: 9781603273626
Format: PDF, Docs
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Handbook of Drug-Nutrient Interactions, Second Edition is an essential new work that provides a scientific look behind many drug-nutrient interactions, examines their relevance, offers recommendations, and suggests research questions to be explored. In the five years since publication of the first edition of the Handbook of Drug-Nutrient Interactions new perspectives have emerged and new data have been generated on the subject matter. Providing both the scientific basis and clinical relevance with appropriate recommendations for many interactions, the topic of drug-nutrient interactions is significant for clinicians and researchers alike. For clinicians in particular, the book offers a guide for understanding, identifying or predicting, and ultimately preventing or managing drug-nutrient interactions to optimize patient care. Divided into six sections all chapters have been revised or are new to this edition. Chapters balance the most technical information with practical discussions and include outlines that reflect the content; discussion questions that can guide the reader to the critical areas covered in each chapter, complete definitions of terms with the abbreviation fully defined and consistent use of terms between chapters. The editors have performed an outstanding service to clinical pharmacology and pharmaco-nutrition by bringing together a multi-disciplinary group of authors. Handbook of Drug-Nutrient Interactions, Second Edition is a comprehensive up-to-date text for the total management of patients on drug and/or nutrition therapy but also an insight into the recent developments in drug-nutrition interactions which will act as a reliable reference for clinicians and students for many years to come.

Bad Astronomy

Author: Philip C. Plait
Publisher: John Wiley & Sons
ISBN: 9780471422075
Format: PDF, ePub, Docs
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Advance praise for Philip Plait s Bad Astronomy "Bad Astronomy is just plain good! Philip Plait clears up every misconception on astronomy and space you never knew you suffered from." --Stephen Maran, Author of Astronomy for Dummies and editor of The Astronomy and Astrophysics Encyclopedia "Thank the cosmos for the bundle of star stuff named Philip Plait, who is the world s leading consumer advocate for quality science in space and on Earth. This important contribution to science will rest firmly on my reference library shelf, ready for easy access the next time an astrologer calls." --Dr. Michael Shermer, Publisher of Skeptic magazine, monthly columnist for Scientific American, and author of The Borderlands of Science "Philip Plait has given us a readable, erudite, informative, useful, and entertaining book. Bad Astronomy is Good Science. Very good science..." --James "The Amazing" Randi, President, James Randi Educational Foundation, and author of An Encyclopedia of Claims, Frauds, and Hoaxes of the Occult and Supernatural "Bad Astronomy is a fun read. Plait is wonderfully witty and educational as he debunks the myths, legends, and 'conspiracies that abound in our society. 'The Truth Is Out There' and it's in this book. I loved it!" --Mike Mullane, Space Shuttle astronaut and author of Do Your Ears Pop in Space?

Successful Grant Writing

Author: Kevin J. Lyons PhD
Publisher: Springer Publishing Company
ISBN: 9780826192615
Format: PDF, ePub, Docs
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This fully updated and revised edition of a classic guide to grant writing for health and human service professionals reflects the two major changes in the field: new NIH application processes and an increased emphasis on interprofessional and team approaches to science. New case examples reflect grant writing strategies for a great variety of health and human service professions, and the text includes an enhanced focus on online methods for organizing grant submissions. A new section on special considerations for submitting grants addresses specific types of research including community-based participatory research, mixed methods, behavioral intervention research, and dissertation and , mentorship proposals. The new chapter on common writing challenges and solutions provides examples of strong and weak statements and highlights the importance of writing with precision. Additionally, this new edition provides an expanded section on post-award requirements and links to NIH videos about grant writing. Written for individuals in both academic and practice settings, the guide addresses, step-by-step, the fundamental principles for effectively securing funding. It is the only book to provide grant-writing information that encompasses many disciplines and to focus on building a research career with grant writing as a step-by-step process. It provides detailed, time-tested strategies for building an investigative team, highlights the challenges of collaboration, and describes how to determine the expertise needed for a team and the roles of co-investigators. The book addresses the needs of both novice and more experienced researchers. New to the Fourth Edition: Reflects recent changes to the field including an emphasis on interprofessional approaches to science and new NIH application processes Offers additional case examples relevant to social work, nursing, psychology, rehabilitation, and occupational, physical, and speech therapies Provides links to NIH websites containing videos on grant writing Includes chapter opener objectives Expands section on post-award requirements Focuses on electronic mechanisms for organizing grant submissions