A Regulatory Overview
Author: Mark P. Mathieu,Christopher-Paul Milne
Publisher: Barnett Educational Services / Chi
"Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: how the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements; how the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes; how CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process; how the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions; and which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process."--Publisher's description.
With Case Studies Using S-Plus
Author: Steven P. Millard,Andreas Krause
Publisher: Springer Science & Business Media
Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
Author: Ali S. Faqi
Publisher: Academic Press
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source
Author: Ali S. Faqi
Publisher: Academic Press
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology
Author: Loyd Allen
Publisher: Lippincott Williams & Wilkins
Long established as a trusted core text for pharmaceutics courses, this gold standard book is the most comprehensive source on pharmaceutical dosage forms and drug delivery systems available today. Reflecting the CAPE, APhA, and NAPLEX® competencies, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems covers physical pharmacy, pharmacy practice, pharmaceutics, compounding, and dosage forms, as well as the clinical application of the various dosing forms in patient care. This Tenth Edition has been fully updated to reflect new USP standards and features a dynamic new full color design, new coverage of prescription flavoring, and increased coverage of expiration dates.
A Preliminary Report of a Case Study
Author: Jasmin Torres Flores
Expert Consult: Online
Author: Michael G. Newman,Henry Takei,Perry R. Klokkevold,Fermin A. Carranza
Publisher: Elsevier Health Sciences
The most widely used periodontics text, Carranza's Clinical Periodontology provides both print and online access to basic procedures as well as the latest in advanced procedures and techniques in reconstructive, esthetic, and implant therapy. Not only does this book show how to do periodontal procedures, it describes how to best manage the outcomes and explains the evidence supporting each treatment. Written by leading experts Michael Newman, Henry Takei, Perry Klokkevold, and Fermin Carranza, along with a pool of international contributors, this edition also discusses the close connection between oral health and systemic disease. A new Expert Consult website includes the entire, fully searchable contents of the book, and takes learning to a whole new level with content updates, videos, a drug database, and much more. Comprehensive coverage describes all aspects of periodontics in a single volume, including periodontal pathology, the etiology of periodontal diseases, the relationship between periodontal disease and systemic health, treatment of periodontal diseases, oral implantology, supportive treatment, and ethics, legal, and practical matters. Problem-solving, scenario-based learning opportunities use well-documented case reports to help you learn both basic and advanced procedures and techniques. 'Speed to competence' is enhanced with access to print, online, and mobile platforms. A unique approach combines evidence-based decision-making, science transfer, and classification/nomenclature throughout every chapter. A one-of-a-kind Genetic Factors and Periodontal Disease chapter examines the role of genetic factors in gum disease. In-depth information serves as an excellent foundation in preparing for the National Board Dental Exam. Coverage of the latest advances includes the emerging link between periodontal disease and systemic health. Full-color illustrations depict the newest developments in surgical technology. A new Multidisciplinary Approach to Dental and Periodontal Problems chapter discusses the importance of collaborative care in the practice of periodontics. Etiology of Periodontal Diseases (Part 4) provides a more comprehensive background in periodontal anatomy, physiology, and pathogenesis.
Category: Pharmaceutical industry
Author: Shayne C. Gad
THE FIRST COMPREHENSIVE GUIDE TO THE METHODS AND TECHNIQUES OF DRUG DISCOVERY The Drug Discovery Handbook gives professionals a tool to facilitate drug discovery by bringing together, for the first time in one resource, a compendium of methods and techniques that need to be considered when developing new drugs. This comprehensive, practical guide presents an explanation of the latest techniques and methods in drug discovery, including: Genomics, proteomics, high-throughput screening, and systems biologySummaries of how these techniques and methods are used to discover new central nervous system agents, antiviral agents, respiratory drugs, oncology drugs, and moreSpecific approaches to drug discovery, including problems that are encountered, solutions to these problems, and limitations of various methods and techniques The thorough coverage and practical, scientifically valid problem-solving approach of Drug Discovery Handbook will serve as an invaluable aid in the complex task of developing new drugs.
a regulatory overview
Author: Mark P. Mathieu
Publisher: Parexel International Corp.
Category: Political Science
A Guide to Current Resources
Author: Bonnie Snow
Publisher: Neal Schuman Pub
This is the long-awaited third edition of the most comprehensive compilation of drug information resources available. A co-publication with the Medical Library Association, it draws on industry expert Bonnie Snow's 30+ years of experience with pharmaceutical information needs and applications. Snow reviews 400+ print and electronic resources.More than a bibliography, this readable guide brings together the best resources plus practical advice on everything from expert search techniques to core collections for libraries. Subject areas covered include: pharmaceutical technology; legal and regulatory issues world-wide; industrial pharmacy; market research; product guides and prescribing information in the global marketplace; drug interactions; drug effects on pregnancy, lactation, and reproduction; pharmacovigilance; and much, much more. Completely revised, reorganized, and updated, the third edition focuses on information sources not covered elsewhere. Absolutely unique in its value as both a desk reference and a text for classroom use or self-study, this edition manages to meet the needs of students, information professionals, health care providers, and pharmacy practitioners.
Author: Vanaja V. Ragavan
Drug Development for Women provides a comprehensive review and analyzes the scientific and social environments associated with developing drugs for women related to all aspects of their reproductive life cycle from puberty to old age. Such a text is long overdue. The demand for action in women?s health research and practice in many countries, as well as the poor standards of information in some areas, makes a compelling case for this book. The issues covered include: Women in clinical trials: protection or inclusion? Historical perspectives on the development of reproductive drugs Market research and demographic forces Legal issues in drug development and marketing Principles and practice of drug development in contraception and reproductive disease Health care issues during the post reproductive years, including sections on menopause and cardiovascular disease Comprehensive and rationally collated appendices of marketed drugs and drugs in development, which will be a valuable resource for readers This book is essential reading for all those working in the areas of pharmaceutical development, regulatory agencies, medicine, nursing and pharmacy, and also for allied health professionals, physicians, legal and ethical organizations and university- and community-based women?s studies programmes.
Author: Glenn J. Jaffe,Paul Ashton,P. Andrew Pearson
Publisher: CRC Press
This reference studies the most recent advances in the development of ocular drug delivery systems. Covering methods to treat or prevent ocular inflammation, retinal vascular disease, retinal degeneration, and proliferative eye disease, this source covers breakthroughs in the management of endophthalmitis, uveitis, diabetic macular edema, and age-related macular degeneration.
Category: Liquid chromatography
Author: Sam Salek,Andrew Edgar
Pharmaceutical Ethics is an important text, which aims to provide the ethical guidelines much needed by the pharmaceutical industry. By focusing on many of the central issues such as the ethical aspects of clinical trials, informed consent, physician or patient choice and pharmaceutical advertising, this text will provide very good coverage of an area which perhaps still lacks coherent instruction. * Covers ethical issues involved in the testing and use of pharmaceuticals on human beings * Investigates issues such as whether choice of drug should lie with the physician or the patient * Looks at a wide variety of subjects connected with pharmaceutical ethics. * Focuses specifically on the issues surrounding the pharmaceutical industry, not medicine in general. * Fulfils an important need in the Pharmaceutical Industry.
Category: Medical laws and legislation, International
An Essential Guide
Author: Gregg N. Milligan,Alan D. T. Barrett
Publisher: John Wiley & Sons
Vaccinology: An Essential Guide outlines in a clear,practical format the entire vaccine development process, fromconceptualization and basic immunological principles through toclinical testing and licensing of vaccines. With anoutstanding introduction to the history and practice ofvaccinology, it also guides the reader through the basic sciencerelating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economicand geographical issues that drive vaccine development and trials,it also presents vaccine delivery strategies, novel vaccineplatforms (including experimental vaccines and pathogens), antigendevelopment and selection, vaccine modelling, and the developmentof vaccines against emerging pathogens and agents of bioterror.There are also sections devoted to veterinary vaccines andassociated regulatory processes. Vaccinology: An Essential Guide is a perfect tool fordesigned for undergraduate and graduate microbiologists andimmunologists, as well as residents, fellows and trainees ofinfectious disease and vaccinology. It is also suitable for allthose involved in designing and conducting clinical vaccine trials,and is the ideal companion to the larger reference bookVaccinology: Principles and Practice.
hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health