Guidebook for Drug Regulatory Submissions

Author: Sandy Weinberg

Publisher: John Wiley & Sons

ISBN: 0470456175

Category: Medical

Page: 392

View: 7788

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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.

Topical and Transdermal Drug Delivery

Principles and Practice

Author: Heather A. E. Benson,Adam C. Watkinson

Publisher: John Wiley & Sons

ISBN: 1118140494

Category: Medical

Page: 432

View: 2577

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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

An Introduction to Clinical Trials: Second Edition

Author: J. Rick Turner

Publisher: Springer Science & Business Media

ISBN: 9781441964182

Category: Medical

Page: 256

View: 538

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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.

Cost-Contained Regulatory Compliance

For the Pharmaceutical, Biologics, and Medical Device Industries

Author: Sandy Weinberg

Publisher: John Wiley & Sons

ISBN: 9781118002278

Category: Medical

Page: 296

View: 3689

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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.

Instrumentelle Analytik

Grundlagen - Geräte - Anwendungen

Author: Douglas A. Skoog,James J. Leary

Publisher: Springer-Verlag

ISBN: 366207916X

Category: Science

Page: 900

View: 1674

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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.

Pharmaceutical Computer Validation Introduction Guidebook

Author: Daniel Farb,Bruce Gordon

Publisher: UniversityOfHealthCare

ISBN: 1594912629

Category: Medical

Page: 111

View: 503

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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.

Eine Erinnerung an Solferino

Author: Henry Dunant

Publisher: Theclassics.Us

ISBN: 9781230455570

Category:

Page: 38

View: 4786

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Dieses historische Buch kann zahlreiche Tippfehler und fehlende Textpassagen aufweisen. Kaufer konnen in der Regel eine kostenlose eingescannte Kopie des originalen Buches vom Verleger herunterladen (ohne Tippfehler). Ohne Indizes. Nicht dargestellt. 1863 edition. Auszug: ...zum dritten Male zwei der grossten Machte der neueren Zeit sich im blutigen Kampfe massen, wurden noch immer die zahlreichen und traurigen Menfchenreste jenes Tages gesammelt, die selbst auf dem Kirchhofe die Kreuze und Grabsteine mit Blut bedeckten. Gegen 9 Uhr kam ich nach Cavriana; es war ein in seiner Art einziges und grossartiges Schauspiel, den Kriegstrain zu sehen, welcher das Hauptquartier des Kaisers der Franzosen umgab. Ich suchte den Herzog von Magenta, den ich die Ehre hatte, personlich zu kennen. Da ich nicht genau wusste, wo in diesem Augenblicke sein Armeecorps lagerte, so liess ich mein Cabriolet auf einem kleinen Platze halten, gegenuber dem Hause, in welchem seit Freitag Abend Kaiser Napoleon wohnte; und so befand ich mich nun plotzlich inmitten einer Gruppe von Generalen, welche auf einfachen Strohstuhleu oder selbst auf holzernen Schemeln sassen, und in der Frische des Abends, gegenuber dem improuisirten Palaste ihres Herrschers, ihre Cigarren rauchteu. Wahrend ich mich erkundigte, in welcher Richtung ich den Marschall Mac-Mahon treffen konne, befragten diese Generale ihrerseits den mich begleitenden Corporal, welchen sie neben meinem Kutscher sitzend fur meine Ordonnanz hielten): sie wollten namlich wissen, wer ich sei und zugleich erfahren, welchen Auftrag ich wohl haben konne; denn es siel ihnen nicht ein, dass ein gewohnlicher Tourist sich allein in die Lager wage und, bis nach Cavriaua gekommen, zu so spater Stunde noch weiter wolle. Der Corporal, der selbst keinen Aufschluss geben konnte, blieb naturlich sehr schweigsam hieruber, obgleich e

Der Marsianer

Roman

Author: Andy Weir

Publisher: Heyne Verlag

ISBN: 3641144000

Category: Fiction

Page: 512

View: 7268

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Gestrandet auf dem Mars Der Astronaut Mark Watney war auf dem besten Weg, eine lebende Legende zu werden, schließlich war er der erste Mensch in der Geschichte der Raumfahrt, der je den Mars betreten hat. Nun, sechs Tage später, ist Mark auf dem besten Weg, der erste Mensch zu werden, der auf dem Mars sterben wird: Bei einer Expedition auf dem Roten Planeten gerät er in einen Sandsturm, und als er aus seiner Bewusstlosigkeit erwacht, ist er allein. Auf dem Mars. Ohne Ausrüstung. Ohne Nahrung. Und ohne Crew, denn die ist bereits auf dem Weg zurück zur Erde. Es ist der Beginn eines spektakulären Überlebenskampfes ...

Und meine Welt steht Kopf

Author: Randa Abdel-Fattah

Publisher: N.A

ISBN: 9783473352678

Category:

Page: 316

View: 728

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Amal, 16, ist arabischstämmige Muslima und lebt mit ihren Eltern in Australien. Eines Tages entschliesst sie sich freiwillig, das Kopftuch zu tragen. Ein mutiger Entschluss, der Amals Welt ganz schön auf den Kopf stellt ... Ab 13.

Health care industry

new trends and new problems : ALI-ABA course of study materials

Author: American Law Institute-American Bar Association Committee on Continuing Professional Education

Publisher: N.A

ISBN: N.A

Category: Medical

Page: 260

View: 4925

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Agent Gxp FDA Part 11 Guidebook

Author: Daniel Farb,Daniel Farb, M.D.,Bruce Gordon

Publisher: UniversityOfHealthCare

ISBN: 1594912734

Category: Medical

Page: 215

View: 2269

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Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course will teach you the history of Part 11, the regulations of Part 11, the implementation of Part 11, the applications of Part 11, the ideas behind Part 11 in order to apply them to new situations, and how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. Readers will enjoy the approachable, compact, conversational style of the title. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version. This is part of the highly acclaimed UniversityOfHealthCare series on FDA regulations.

Guidebook

Toxic Substances Control Act

Author: George S. Dominguez

Publisher: CRC PressI Llc

ISBN: N.A

Category: Technology & Engineering

Page: 240

View: 1579

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