New Drug Development

Author: Mark P. Mathieu
Publisher: Barnett Educational Services / Chi
ISBN: 1882615859
Release Date: 2008-01-01
Genre: Medical

"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.

Applied Statistics in the Pharmaceutical Industry

Author: Steven P. Millard
Publisher: Springer Science & Business Media
ISBN: 9781475734669
Release Date: 2013-11-09
Genre: Medical

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.

New Drug Development

Author: J. Rick Turner
Publisher: Springer Science & Business Media
ISBN: 1441964185
Release Date: 2010-07-16
Genre: Medical

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

Using the Pharmaceutical Literature

Author: Sharon Srodin
Publisher: CRC Press
ISBN: 9780849374524
Release Date: 2006-02-16
Genre: Medical

Gathering information of critical importance for professionals in the pharmaceutical and medical device industries, this guide provides a comprehensive overview of key resources, such as databases, on-line directories, reports, and periodicals-providing at-a-glance guidance and collection development tools for information professionals in this field. Each chapter corresponds to a key stage or component of the drug development processin a typical pharmaceutical company and covers the types of information typically required at that particular phase.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 9780123878151
Release Date: 2013
Genre: Medical

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

Ansel s Pharmaceutical Dosage Forms and Drug Delivery Systems

Author: Loyd Allen
Publisher: Lippincott Williams & Wilkins
ISBN: 9781469871943
Release Date: 2014-01-30
Genre: Medical

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.


Author: Georg Krücken
Publisher: Springer-Verlag
ISBN: 9783322868848
Release Date: 2013-07-02
Genre: Social Science

Die Arbeit unternimmt den Versuch, theoretische Einsichten der Risikosoziologie für den Bereich der Politik fruchtbar zu machen. An Luhmanns Unterscheidung von externen Gefahren und im Entscheidungssystem anfallenden Risiken schließt die forschungsleitende These an, daß technische und ökologische Gefahren in politische Risiken transformiert werden. Diese These wird anhand von zwei empirischen Bereichen der politischen Gefahrenregulierung überprüft. Mit der politischen Regulierung von Arzneimittelgefahren und der seit den achtziger Jahren einsetzenden Klimapolitik werden Fallbereiche untersucht, die gesellschaftlich ebenso wichtig wie soziologisch noch weitgehend unerforscht sind. Beide Studien belegen die besondere Bedeutung von politischer Risikoaversion, die jedoch zu völlig unterschiedlichen Regulierungsformen führt. Die Untersuchungsergebnisse sind nicht nur für theoretische Diskussionen zur "Politik in der Risikogesellschaft" relevant, sondern auch für die regulative Praxis.

Multiple Sclerosis Therapeutics

Author: Richard Rudick
Publisher: CRC Press
ISBN: 0415805821
Release Date: 1999-09-01
Genre: Medical

This textbook examines the most important aspects of multiple sclerosis that impact on clinical trial design, on the development of new disease therapies and on patient care. The international team of contributors discuss the clinical course of multiple sclerosis, its clinical heterogeneity, the presence of subclinical disease activity which occurs during the early stages of the disease. Multiple sclerosis presents clinical challenges: from unexpected and irregular relapses to profressive deterioration.

Contract Research and Development Organizations

Author: Shayne C. Gad
Publisher: Springer Science & Business Media
ISBN: 146140049X
Release Date: 2011-08-04
Genre: Medical

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

The Clinical Evaluation of a Food Additive

Author: Christian Tschanz
Publisher: CRC Press
ISBN: 0849349737
Release Date: 1996-06-25
Genre: Technology & Engineering

This useful book reviews and analyzes the rigorous scientific, regulatory, and clinical testing and evaluation applied to the widely used food additive aspartame. In one compact volume you gain access to extensive information illustrating the increased recognition by regulatory agencies of the usefulness of human studies in evaluating new food additives. The Clinical Evaluation of a Food Additive: Assessment of Aspartame begins by describing the nuts and bolts of food additive safety evaluation in humans, including an insightful historical perspective of the development of good clinical practice guidelines. It provides the regulatory requirements for human research, as well as key elements for the design and conduct of human studies. The scientific and regulatory considerations of food additive safety are explored, including interesting descriptions of aspartame's key animal safety studies. In addition, the book reviews the medical postmarketing surveillance system developed for identifying and evaluating reports of aspartame's alleged adverse health effects. Through meticulous research and systematic clarity, The Clinical Evaluation of a Food Additive: Assessment of Aspartame provides work-saving, state-of-the-art examples to guide future testing and evaluation of tomorrow's food additives.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Author: Allen Cato
Publisher: CRC Press
ISBN: 9780824744809
Release Date: 2002-03-26
Genre: Medical

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Drug and Biological Development

Author: Ronald Evens
Publisher: Springer Science & Business Media
ISBN: 9780387690940
Release Date: 2007-08-18
Genre: Medical

This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.

Total R D Management

Author: Roger Dabbah
Publisher: CRC Press
ISBN: 9780203502426
Release Date: 2004-06-02
Genre: Medical

Drawing on a lifetime of experience, Roger Dobbah gives readers an in-depth view of R&D survival strategies and tactics and demonstrates how to apply them to any organization. The author provides insights into the role of R&D, the crucial topic of creativity and innovation, and the differences and similarities between general management and R&D management. He covers R&D resources, organizational structures, internal and external environments, R&D interface with other functions, objectives and adaptation, and integration of strategies. It includes coverage of the new R&D dimension of pharmacoeconomics and a full discussion of the regulatory environment impacting the present and future of R&D.

Intraocular Drug Delivery

Author: Glenn J. Jaffe
Publisher: CRC Press
ISBN: 1420016504
Release Date: 2006-03-13
Genre: Medical

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.