a regulatory overview

Author: Mark P. Mathieu,Anne G. Evans,Eric L. Hurden

Publisher: N.A

ISBN: N.A

Category: Law

Page: 328

View: 2849

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A Regulatory Overview

Author: N.A

Publisher: Parexel International Corporation

ISBN: N.A

Category: Drugs

Page: 282

View: 1530

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With Case Studies Using S-Plus

Author: Steven P. Millard,Andreas Krause

Publisher: Springer Science & Business Media

ISBN: 1475734662

Category: Medical

Page: 514

View: 6644

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.
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Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 0123878152

Category: Medical

Page: 885

View: 8844

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
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Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 0128036214

Category: Medical

Page: 986

View: 949

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
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Author: Loyd Allen

Publisher: Lippincott Williams & Wilkins

ISBN: 1469871947

Category: Medical

Page: 832

View: 1277

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.
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Expert Consult: Online

Author: Michael G. Newman,Henry Takei,Perry R. Klokkevold,Fermin A. Carranza

Publisher: Elsevier Health Sciences

ISBN: 0323227996

Category: Medical

Page: 904

View: 2366

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.
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An Essential Guide

Author: Gregg N. Milligan,Alan D. T. Barrett

Publisher: John Wiley & Sons

ISBN: 111863652X

Category: Medical

Page: 400

View: 7072

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.
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Author: Shayne C. Gad

Publisher: CRC Press

ISBN: 9780203634011

Category: Medical

Page: 188

View: 3924

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your
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Their Role in Global Product Development

Author: Shayne C. Gad,Charles B. Spainhour

Publisher: Springer Science & Business Media

ISBN: 9781461400493

Category: Medical

Page: 212

View: 2195

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.
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Author: Michael Margolis

Publisher: O'Reilly Germany

ISBN: 3868993541

Category: Computers

Page: 624

View: 2654

Mit dem Arduino-Kochbuch, das auf der Version Arduino 1.0 basiert, erhalten Sie ein Füllhorn an Ideen und praktischen Beispielen, was alles mit dem Mikrocontroller gezaubert werden kann. Sie lernen alles über die Arduino-Softwareumgebung, digitale und analoge In- und Outputs, Peripheriegeräte, Motorensteuerung und fortgeschrittenes Arduino-Coding. Egal ob es ein Spielzeug, ein Detektor, ein Roboter oder ein interaktives Kleidungsstück werden soll: Elektronikbegeisterte finden über 200 Rezepte, Projekte und Techniken, um mit dem Arduino zu starten oder bestehende Arduino-Projekt mit neuen Features aufzupimpen.
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Interviews mit Top-Tradern der Finanzwelt

Author: Jack D. Schwager

Publisher: FinanzBuch Verlag

ISBN: 3862484505

Category: Business & Economics

Page: 513

View: 7335

Jack D. Schwager ist einer der ganz Großen in der internationalen Finanzszene, seine "Magier der Märkte"-Buchreihe gehört weltweit seit Jahren zu den Standardwerken. In Interviews mit den Top-Tradern unserer Zeit zeigt Schwager auf, was diese Menschen so unglaublich erfolgreich macht. Sie alle verwenden zwar unterschiedliche Methoden, aber sie haben nicht nur scheinbar einen Vorteil gegenüber den Mitstreitern. Wie machen sie das? Was ist es, das sie von anderen unterscheidet? Was kann der durchschnittliche Investor daraus lernen? In diesem einmaligen Werk legen sie ihre finanziellen Strategien offen, die sie zu ihrem Erfolg katapultiert haben, aber auch Niederlagen und Verluste werden eingestanden. Ein Muss für jeden Börsianer! Das Wichtigste in Kürze: Ein Klassiker der Investmentliteratur Pflichtlektüre für jeden Anleger Umsetzbare Tipps von Insidern Blicken Sie den Profis über die Schulter
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Author: Stephen Hawking

Publisher: Klett-Cotta

ISBN: 3608115102

Category: Political Science

Page: 160

View: 9899

Stephen Hawkings Vermächtnis In seinem letzten Buch gibt Stephen Hawking Antworten auf die drängendsten Fragen unserer Zeit und nimmt uns mit auf eine persönliche Reise durch das Universum seiner Weltanschauung. Seine Gedanken zu Ursprung und Zukunft der Menschheit sind zugleich eine Mahnung, unseren Heimatplaneten besser vor den Gefahren unserer Gegenwart zu schützen. Zugänglich und klar finden Sie in diesem Buch Hawkings Antworten auf die drängendsten Fragen unserer Zeit. - Warum gibt es uns Menschen überhaupt? - Und woher kommen wir? - Gibt es im Weltall andere intelligente Lebewesen? - Existiert Gott? - In welchem Zustand befindet sich unser Heimatplanet? - Werden wir auf der Erde überleben? - Retten oder zerstören uns Naturwissenschaften und Technik? - Hilft uns die künstliche Intelligenz, die Erde zu bewahren? - Können wir den Weltraum bevölkern? - Wie werden wir die Schwächsten – Kinder, Kranke, alte Menschen – schützen? - Wie werden wir unsere Kinder erziehen? Brillanter Physiker, revolutionärer Kosmologe, unerschütterlicher Optimist. Für Stephen Hawking bergen die Weiten des Universums nicht nur naturwissenschaftliche Geheimnisse. In seinem persönlichsten Buch beantwortet der Autor die großen Fragen des menschlichen Lebens und spricht die wichtigsten Themen unserer Zeit an. Zugänglich und klar erläutert er die Folgen des menschlichen Fortschritts – vom Klimawandel bis hin zu künstlicher Intelligenz – und diskutiert seine Gefahren. Hier finden Sie Hawkings Antworten auf die Urfragen der Menschheit. Ein großer Appell an politische Machthaber und jeden Einzelnen von uns, unseren bedrohten Heimatplaneten besser zu schützen.
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Die Geschichte meiner Familie und einer Gesellschaft in der Krise

Author: J. D. Vance

Publisher: Ullstein Buchverlage

ISBN: 3843715777

Category: Biography & Autobiography

Page: 304

View: 1199

Seine Großeltern versuchten, mit Fleiß und Mobilität der Armut zu entkommen und sich in der Mitte der Gesellschaft zu etablieren. Doch letztlich war alles vergeblich. J. D. Vance erzählt die Geschichte seiner Familie — eine Geschichte vom Scheitern und von der Resignation einer ganzen Bevölkerungsschicht. Armut und Chaos, Hilflosigkeit und Gewalt, Drogen und Alkohol: Genau in diesem Teufelskreis befinden sich viele weiße Arbeiterfamilien in den USA — entfremdet von der politischen Führung, abgehängt vom Rest der Gesellschaft, anfällig für populistische Parolen. Früher konnten sich die »Hillbillys«, die weißen Fabrikarbeiter, erhoffen, sich zu Wohlstand zu schuften. Doch spätestens gegen Ende des 20sten Jahrhunderts zog der Niedergang der alten Industrien ihre Familien in eine Abwärtsspirale, in der sie bis heute stecken. Vance gelingt es wie keinem anderen, diese ausweglose Situation und die Krise einer ganzen Gesellschaft eindrücklich zu schildern. Sein Buch bewegte Millionen von Lesern in den USA und erklärt nicht zuletzt den Wahltriumph eines Donald Trump.
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Roman

Author: Phillip M. Margolin

Publisher: N.A

ISBN: 9783426623251

Category: American fiction

Page: 412

View: 7148

Fesselnder Justizthriller über einen jungen ehrgeizigen Anwalt, eine unerschrockene Detektivin und ihr dramatischer Kampf gegen den Medikamentenmissbrauch eines grossen Konzerns.
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