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Guidebook For Drug Regulatory Submissions

Author : Sandy Weinberg
ISBN : 9780470456170
Genre : Medical
File Size : 42.83 MB
Format : PDF, ePub, Docs
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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.
Category: Medical

Cost Contained Regulatory Compliance

Author : Sandy Weinberg
ISBN : 111800227X
Genre : Medical
File Size : 86.80 MB
Format : PDF, Mobi
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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.
Category: Medical

New Drug Development

Author : J. Rick Turner
ISBN : 1441964185
Genre : Medical
File Size : 55.94 MB
Format : PDF
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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.
Category: Medical

Topical And Transdermal Drug Delivery

Author : Heather A. E. Benson
ISBN : 9781118140499
Genre : Medical
File Size : 63.82 MB
Format : PDF, Kindle
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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.
Category: Medical

Pharmaceutical Computer Validation Introduction Guidebook

Author : Daniel Farb
ISBN : 9781594912627
Genre : Medical
File Size : 63.36 MB
Format : PDF
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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.
Category: Medical

Agent Gxp Fda Part 11 Guidebook

Author : Daniel Farb
ISBN : 9781594912733
Genre : Medical
File Size : 60.52 MB
Format : PDF, Docs
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Teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. This book is helpful for medical device manufacturing and clinical research personnel in FDA-regulated industries.
Category: Medical


Author : George S. Dominguez
ISBN : UCLA:31158010423274
Genre : Technology & Engineering
File Size : 47.77 MB
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Category: Technology & Engineering

International Clinical Trials

Author : Dominique Brunier
ISBN : 1574910949
Genre : Medical
File Size : 89.24 MB
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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.
Category: Medical

Chemistry And Industry

Author :
ISBN : UCSD:31822022712822
Genre : Chemistry, Technical
File Size : 76.21 MB
Format : PDF, Mobi
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Category: Chemistry, Technical