Guidebook for Drug Regulatory Submissions

Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 9780470456170
Release Date: 2009-02-23
Genre: Medical

Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

Cost Contained Regulatory Compliance

Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 111800227X
Release Date: 2011-04-18
Genre: Medical

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

Topical and Transdermal Drug Delivery

Author: Heather A. E. Benson
Publisher: John Wiley & Sons
ISBN: 9781118140499
Release Date: 2012-02-03
Genre: Medical

Practical drug development approaches presented by leadingexperts Designed to support the development of new, effectivetherapeutics, Topical and Transdermal Drug Delivery: Principlesand Practice explains the principles underlying the field andthen demonstrates how these principles are put into practice in thedesign and development of new drug products. Drawing together andreviewing the latest research findings, the book focuses onpractical, tested, and proven approaches that are backed byindustry case studies and the authors' firsthand experience.Moreover, the book emphasizes the mechanistic information that isessential for successful drug product development. Topical and Transdermal Drug Delivery: Principles andPractice is divided into two parts: Part One, Current Science, Skin Permeation, andEnhancement Approaches, offers readers a fundamental understandingof the underlying science in the field. It describes the principlesand techniques needed to successfully perform experimentalapproaches, covering such issues as skin permeation, enhancement,and assessment. Part Two, Topical and Transdermal Product Development,guides readers through the complete product development processfrom concept to approval, offering practical tips and cautions fromexperts in the field. This part also discusses regulations that arespecific to the development of dermal drug products. The finalchapter explores current and future trends, forecasting newdevelopment techniques and therapeutics. Throughout the book, the authors clearly set forth the basicscience and experimental procedures, making it possible forresearchers to design their own experimental approaches andaccurately interpret their results. With contributions from experienced drug researchers, this textis highly recommended for all researchers involved in topical andtransdermal product development who need to know both the state ofthe science and the standards of practice.

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.

Pharmaceutical Computer Validation Introduction Guidebook

Author: Daniel Farb
Publisher: UniversityOfHealthCare
ISBN: 9781594912627
Release Date: 2005
Genre: Medical

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.

International Clinical Trials

Author: Dominique Brunier
Publisher: CRC Press
ISBN: 1574910949
Release Date: 1999-06-30
Genre: Medical

Regulations and standards involving clinical trials vary from country to country based on different laws, cultures, and social structures. International Clinical Trials: A Guidebook to National Drug Laws succeeds in collecting current guidelines into a single source that allows regulatory bodies in the pharmaceutical industry to prepare product approval submissions and meet international standards for performing clinical trials. It covers regulations in 34 countries in Europe, Austral-Asia, Africa, North America, and South America. Authored by locally based experts that include government authorities, national Ethics Committee chairpersons, company regulatory affairs professionals, and independent consultants, this book provides the information necessary for performing clinical trials, from initiation to termination and reporting. It includes forms and excerpts from existing regulations and interprets processes as they relate to ICH GCP guidelines. While chapters are presented in a similar format, they differ in their content to reflect the differing requirements throughout the world. A cornerstone in this field, this book is indispensable to those who must understand and comply with the standards of biomedical research on human beings as the pharmaceutical industry and regulators work to establish a universal set of requirements for performing clinical trials.

Pharmakokinetik

Author: Erich Gladtke
Publisher: Springer-Verlag
ISBN: 9783662092712
Release Date: 2013-03-09
Genre: Medical


Instrumentelle Analytik

Author: Douglas A. Skoog
Publisher: Springer-Verlag
ISBN: 9783662079164
Release Date: 2013-04-17
Genre: Science

Mit der deutschsprachigen Ausgabe des Standard-Lehrbuchs zur Instrumentellen Analytik von Skoog und Leary schließt sich endlich eine Lücke im Buchangebot für fortgeschrittene Studenten der Chemie an Universitäten und Fachhochschulen. Aufgrund des multidisziplinären Eindringens der Analytischen Chemie in andere Bereiche richtet sich das Buch auch an Physiker, Ingenieure und Biochemiker. Das Buch führt aktuell und kompetent in die Grundzüge und Feinheiten der heutigen Instrumentellen Analytischen Chemie ein. Über 530 detailreiche, selbsterklärende Abbildungen, Anhänge zu Statistik und Elektronik, Übungsaufgaben mit Lösungen und viele wichtige Originalzitate ergänzen dieses moderne Lehrbuch für Studierende und Praktiker.

Klinische Ethik

Author: Christian Hick
Publisher: Springer-Verlag
ISBN: 9783540683643
Release Date: 2007-02-15
Genre: Medical

Die Klinische Ethik ist das Einsteigerbuch für die Ethik der Medizin im Querschnittsbereich 2. Darüber hinaus zeigt es den Weg zu ethisch verantwortlichem Handeln im klinischen Alltag. Grundlagen: Patientenverfügung, Sterbehilfe und Pränataldiagnostik. Pro & Contra argumentieren: Ethische Positionen werden ausführlich besprochen und ausgewogen bewertet.- Anschaulich und praxisnah geschrieben, mit zahlreichen Fallgeschichten. Relevant für die Praxis: Rechtlicher Kontext zu jedem Thema. - Empfehlungen ärztlicher Standesvertretungen. - Ethische Konflikte in der medizinischen Ausbildung. - 10 ethische Konfliktfälle zum Üben. Ethik endlich klinisch relevant!

Scale up

Author: Marko Zlokarnik
Publisher: John Wiley & Sons
ISBN: 9783527660469
Release Date: 2012-02-28
Genre: Science

Die Übertagung von Verfahren aus dem Labor-bzw. dem Techni-kumsmaßstab in den industriellen maßstab einer Produktiosanlage ist eine der wichtigsten ingenieurstechnischen Aufgaben in der chemischen Industrie. Die einzige zuverlässige Methode dazu basiert auf der Darstellung von Versuchsergebnissen im zutreffenden dimensions-analytischen Raum, der sich als maßstabsinvariant erweist. Das Buch ist in zwei Teile gegliedert: In der ersten Hälfte werden die vertiefte mathematische Vorkenntnisse dieses Themengebiet näherzubringen. Diskutiert werden die Grundlagen der Dimensionsanalyse, die Behandlung von temperaturabhängigen und von rheologischen Stoffwerten und die Modellübertragung bei Nichtverfügbarkeit von Modellstoffsystemen, sowie bei partieller Ähnlichkeit/ All dies wird dem leser anhand von 20 modernen Beispielen aus der heutigen verfahrenstechnischcen Praxis illustriert, der sich mit 25 in dieser Auflage neu hinzugekommenen Übungsaufgaben sein Verständnis aktive erarbeiten und anhand der Lösungen kontrollieren kann. Im zweitem Teil des Buches werden die einzelnen verfahrenstechnischen Grundoperationen aus den Bereichen mechanische, thermische und chemische Verfahrenstechnik aus der Sicht der Dimensionsanalyse und der Modellübertragung beispielhaft behandelt, und es werden für jede Operation die Maßstabsübertragungsregeln vorgestellt und diskutiert. Das vorliegende Buch wendet sich dementsprechend an Studenten wie auch bereits auf dem gebiet tätige Ingenieure, Chemiker und Verfahrenstechniker.

Arzneimitteltherapie in der Palliativmedizin

Author: Claudia Bausewein
Publisher: "Elsevier,Urban&FischerVerlag"
ISBN: 9783437298707
Release Date: 2015-08-21
Genre: Medical

Palliativmedizinisches Arzneimittelwissen – kompetent und praxisnah Nach über 10 Jahren jetzt die 2. Auflage mit aktuellen, umfassende Informationen zu allen praxisrelevanten Medikamenten im Bereich der Palliativmedizin. Detaillierte Arzneimittelmonografien, nach Organsystemen und Einsatzbereichen geordnet Ausführliche Informationen zu Sonderfällen in der Palliativmedizin wie z.B. Anwendungen außerhalb der Zulassung (''off-label use'') Alternative Applikationsformen Dosierungsanpassung bei Organinsuffizienz Darstellung von Alternativ- und Begleitmedikation Diese deutsche Fassung basiert auf wissenschaftlichen Erkenntnissen und den Erfahrungen langjährig tätiger Palliativmediziner aus dem englischsprachigen Raum, inklusive Pharmazeuten, die sich auf diesen Bereich spezialisiert haben. Die deutsche Fassung wurde von einer spezialisierten Pharmazeutin gemeinsam mit einer erfahrenen Palliativmedizinerin auf die Erfordernisse im deutschsprachigen Raum angepasst. Die neue, 2. Auflage wurde durch zahlreiche weitere Arzneimittelmonografien ergänzt um Präparatebeispiele für die Schweiz und Österreich erweitert inhaltlich auf den aktuellen wissenschaftlichen Stand der Palliativmedizin gebracht

Guidebook

Author: George S. Dominguez
Publisher: CRC PressI Llc
ISBN: UCLA:31158010423274
Release Date: 1983
Genre: Technology & Engineering