New drug development

a regulatory overview

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

Publisher: N.A

ISBN: N.A

Category: Law

Page: 328

View: 4405

New Drug Development

A Regulatory Overview

Author: N.A

Publisher: Parexel International Corporation

ISBN: N.A

Category: Drugs

Page: 282

View: 2601

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 0123878152

Category: Medical

Page: 885

View: 1072

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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 0128036214

Category: Medical

Page: 986

View: 3146

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

Applied Statistics in the Pharmaceutical Industry

With Case Studies Using S-Plus

Author: Steven P. Millard,Andreas Krause

Publisher: Springer Science & Business Media

ISBN: 1475734662

Category: Medical

Page: 514

View: 1629

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

An Introduction to Clinical Trials: Second Edition

Author: J. Rick Turner

Publisher: Springer Science & Business Media

ISBN: 9781441964182

Category: Medical

Page: 256

View: 845

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.

Drug Discovery Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

ISBN: 0471728772

Category: Science

Page: 1496

View: 1525

The Drug Discovery Handbook gives professionals a tool tofacilitate drug discovery by bringing together, for the first timein one resource, a compendium of methods and techniques that needto be considered when developing new drugs. This comprehensive, practical guide presents an explanation of thelatest techniques and methods in drug discovery, including: Genomics, proteomics, high-throughput screening, and systemsbiology Summaries of how these techniques and methods are used todiscover new central nervous system agents, antiviral agents,respiratory drugs, oncology drugs, and more Specific approaches to drug discovery, including problems thatare encountered, solutions to these problems, and limitations ofvarious methods and techniques The thorough coverage and practical, scientifically validproblem-solving approach of Drug Discovery Handbook will serve asan invaluable aid in the complex task of developing new drugs.

Carranza's Clinical Periodontology - E-Book

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: 4664

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.

Vaccinology

An Essential Guide

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

Publisher: John Wiley & Sons

ISBN: 111863652X

Category: Medical

Page: 400

View: 5210

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.

The Selection and Use of Contract Research Organizations

Author: Shayne C. Gad

Publisher: CRC Press

ISBN: 9780203634011

Category: Medical

Page: 188

View: 1415

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

Contract Research and Development Organizations

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: 4193

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.

Rotordynamik

Eine Einführung

Author: R. Gasch,H. Pfützner

Publisher: Springer-Verlag

ISBN: 3662097869

Category: Technology & Engineering

Page: 188

View: 4783

Während noch vor wenigen Jahrzehnten die Forschung auf dem Gebiet der Maschinendynamik hauptsächlich den Kolbenmaschinen galt, ist mittlerweile eine Akzentverschiebung zu den Maschinen mit ausschließlich rotierenden Teilen, wie Turbomaschinen und Elektro motoren eingetreten. Das hängt einmal damit zusammen, daß Gas turbinen, Turbopumpen, Turboverdichter und Elektromotoren Anwen dungsgebiete erobert haben, die früher Kolbenmaschinen vorbehalten waren. Außerdem sind durch das Bestreben, die Leistungsgewichte durch Drehzahlerhöhungen zu verringern, Probleme aufgetreten, wie beispiels weise Fragen der Laufstabilität, die früher ohne Bedeutung für die Praxis waren. Daher wurde die Forschung auf diesem Gebiet in den letzten Jahren intensiviert. In dieser Einführung in die Dynamik biegeelastischer Läufer haben wir versucht, die Fülle interessanter, oft sogar verblüffender Phänomene am einfachsten Rotormodell darzustellen. Wir haben uns auf die Behand lung des Laval-Läufers - der elastischen Welle mit aufgesetzter Scheibe - beschränkt, an dem sich bereits die wichtigsten Erscheinungen auf zeigen lassen. Da die Zahl der Freiheitsgrade niedrig ist, ist meist noch eine geschlossene Lösung der Bewegungsgleichungen möglich. Mit diesem Buch wenden wir uns an Studenten der Hochschulen und an Ingenieure in der Praxis. Wir hoffen, daß durch den sparsamen Ge brauch der höheren Mathematik das Verständnis auch dem Anfänger wesentlich erleichtert wird. Verbesserungsvorschläge und Hinweise auf Fehler nehmen wir gern entgegen.

Arduino Kochbuch

Author: Michael Margolis

Publisher: O'Reilly Germany

ISBN: 3868993541

Category: Computers

Page: 624

View: 1376

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.

The price of innovation: new estimates of drug development costs

Author: Christoph Fürleger

Publisher: GRIN Verlag

ISBN: 3640791673

Category: Business & Economics

Page: 9

View: 3700

Studienarbeit aus dem Jahr 2010 im Fachbereich VWL - Finanzwissenschaft, Universität Bayreuth, Sprache: Deutsch, Abstract: Die vom Bundesministerim für Gesundheit ausgewiesenen Arzneimittelausgaben in der GKV verzeichneten in den letzten 10 Jahren einen nominalen Anstieg um 54,56 Prozent. Der Anteil an den Gesamtausgaben der GKV stieg in diesem Zeitraum von 14,52 auf 17,57 Prozent (vgl. BMG (2010), S. 1). Für das Jahr 2010 errechnete der Schätzerkreis der gesetzlichen Krankenversicherungen im Oktober 2009 eine Deckungslücke von 7,45 Milliarden Euro zwischen den Einnahmen und Ausgaben im Gesundheitsfond (vgl. BVA Schätzerkreis (2009). Zur Entlastung der Ausgabenseite in der GKV werden daher zahlreiche Maßnahmen u.a. im Bereich der Arzneimittelversorgung diskutiert. Im Fokus stehen dabei im Besonderen patentgeschützte Arzneimittel. Für diese Produkte konnte die Pharmaindustrie bisher die Preise, bis zum Erstattungshöchstbetrag, frei festsetzen. Neben der Kosten-Nutzen- Bewertung und weiteren Faktoren sollen nach der aktuellen Gesetzeslage bei der Festlegung des Erstattungshöchstbetrags auch die Entwicklungskosten von Medikamenten berücksichtigt werden (vgl. § 31 Abs. 2a SGB V).

#AskGaryVee

Ein Entrepreneur über Social Media, Selbstbewusstsein, Gewinnen. ...

Author: Gary Vaynerchuk

Publisher: FinanzBuch Verlag

ISBN: 3960920474

Category: Self-Help

Page: 400

View: 716

Fast 50 Millionen aufgerufene Videos auf Youtube, 1,5 Millionen Follower bei Twitter, 2,2 Millionen bei Facebook, New York Times- und Wall Street Journal-Bestsellerautor – Gary Vaynerchuk ist einer der erfolgreichsten Social-Media-Gurus überhaupt. Seine Karriere liest sich wie ein modernes Märchen: Als Kind weißrussischer Einwanderer machte er aus dem Weingeschäft seines Vaters ein Millionen-Imperium – dank E-Commerce. Zusätzlich startete er seinen eigenen Video-Blog auf Youtube, den sich mittlerweile Millionen Gründer und Entrepreneure angesehen haben. In "#AskGaryVee" sind die nützlichsten und interessantesten Fragen des Video-Blogs mit Garys Antworten zusammengestellt und erweitert. Von erfolgreichen Twitter-Strategien für kleine Unternehmen über die Kunst, Promis für die eigene Marke zu gewinnen, bis hin zum wirksamen Launch neuer Produkte. Egal ob man sein eigenes Start-up gründet, in der Digitalbranche arbeitet oder in einer ganz klassischen Firma anheuert, "#AskGaryVee" ist das essenzielle Handbuch, um Großes zu leisten.

Die Biotechnologie-Industrie

Ein Einführungs-, Übersichts- und Nachschlagewerk

Author: Julia Schüler

Publisher: Springer-Verlag

ISBN: 3662471604

Category: Science

Page: 448

View: 5515

Dieses Kompendium zur Biotechnologie-Industrie bietet eine fundierte Einführung und Übersicht zu einer Zukunfts- und Schlüsselbranche. Es informiert über die dahinter stehende Biotechnologie, beleuchtet Entstehung und Rahmenbedingungen der Industrie und stellt umfangreiches sowie aktuelles Zahlenmaterial zum Nachschlagen bereit. Neben der Analyse der US-Biotech-Industrie liegt ein besonderer Fokus auf der Situation in Deutschland. Das Buch ist als Einführungs-, Übersichts- und Nachschlagewerk für alle zu empfehlen, die einen fundierten Einblick in die Biotechnologie-Industrie erhalten möchten, wie z.B. Investoren, branchenfremde Unternehmer, Journalisten, Politiker und andere Interessierte. Für Branchenkenner bietet es eine Zusammenstellung aktueller Trends und Daten.