Pharma Tips

List of Regulatory Affairs Books & E-Books

By: Pharma Tips | Views: 13225 | Date: 26-Feb-2013

This book is a roadmap to the U.S. Food and Drug Administration and drug, biologic, and medical device development. It is written in plain English, with an emphasis on easy access to understanding how this agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges

List of Regulatory Affairs for Drugs, Biologic & Medical Devices Research Books

 

 

Books : FDA Regulatory Affairs - A guide for prescription drugs, medical devices, and biologics


 

This book is a roadmap to the U.S. Food and Drug Administration and drug, biologic, and medical device development. It is written in plain English, with an emphasis on easy access to understanding how this agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges across the United States in need of a simple, concise text from which to learn and teach. The topics in FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual reading of the Laws of the United States of America or the regulations of the U.S. Food and Drug Administration, it’s agencies or any body that regulates the development or approval of drugs, biologics, and medical devices in the United States.

Drug Regulatory Affairs Book

Drug Regulatory Affairs Book


 
Nature of offer : Sell
Company Name : United Books & Periodicals 
 
Year of Establishment : 1981
City & State : Mumbai, Maharashtra
Country : India 
 
Click to View Contact Number
Telephone : +(91)-(22)-26177370
Mobile / Cell Phone : +(91)-9819000772
 
Product Details
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his is the first comprehensive overview of the legal and regulatory framework for marketing authorization applications in Europe, including Switzerland. It gives extensive and valuable advice on how to compile
a marketing authorisation according to the CTD format (Modules 1 – 5 CTD).

The ’Guide’ is subdivided into four major parts

  • Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.
  • Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.
  • Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.
  • Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.

Available as a print or online edition, the ‘Guide’ is a multi-media resource designed to support the different needs of its users.


 

 

Drug Discovery Books @ Snell Library

Cover Art
Flow Cytometry in Drug Discovery & Development - Virginia Litwin, Philip Marder
Call Number: Snell Stacks QH585.5.F56 F575 2011
ISBN: 9780470433560
 
BibliographyIncludes bibliographical references and index.
Summary"This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development"--Provided by publisher.
Additional AuthorLitwin, Virginia.
Marder, Philip.
SubjectFlow cytometry.
Drugs -- Design.
Descriptionxviii, 341 p. : ill. (some col.) ; 25 cm.
ISBN9780470433560 (cloth)
0470433566 (cloth)
WorldCat No.667592522

Cover Art
Lead Generation Approaches in Drug Discovery - Zoran Rankovic, Richard Morphy
ISBN: 0470584165

Genomics in Drug Discovery & Development - Dimitri Semizarov, Eric Blomme
ISBN: 0470409762
AccessLicensed for use by the entire Northeastern community including authenticated remote access.
BibliographyIncludes bibliographical references and index.
ContentsLead discovery : the process / William F. Michne -- High throughput screening approach to lead discovery / Zoran Rankovic, Craig Jamieson, and Richard Morphy -- In silico screening / Dagmar Stumpfe, Hanna Geppert, and Jürgen Bajorath -- Fragment-based lead discovery / Jeffrey S. Albert -- Design of multitarget ligands / Richard Morphy and Zoran Rankovic -- De novo drug design / Gisbert Schneider, Markus Hartenfeller, Ewgenij Proschak -- Role of natural products in drug discovery / Hugo Lachance, Stefan Wetzel, and Herbert Waldmann -- Early screening for ADMET properties / Dennis A. Smith -- Role of chemistry in lead discovery / Roland E. Dolle and Karin Worm.
Additional AuthorRankovic, Zoran.
Morphy, Richard.
Wiley InterScience (Online service)
SubjectDrug development.
Drugs -- Design.
High throughput screening (Drug development)
GenreElectronic books.
Description1 online resource (xi, 295 p.) : ill.
Related ToOriginal 9780470257616 047025761X (DLC) 2009040188 (OCoLC)435422355
Other Standard No.10.1002/9780470584170 doi
ISBN9780470584170
0470584173
9780470584163 (electronic bk.)
0470584165 (electronic bk.)
9780470257616 (cloth)
WorldCat No.644163086

Cover Art
Preclinical Drug Development 2nd ed. - Mark C. Rogge, David R. Taft
Call Number: Snell Stacks RM301.25 P745 2010
ISBN: 9781420084726
 
BibliographyIncludes bibliographical references and index.
ContentsThe scope of preclinical drug development : an introduction and framework / Mark C. Rogge -- Lead molecule selection : pharmaceutical profiling and toxicity assessments / P.L. Bullock -- Interspecies differences in physiology and pharmacology : extrapolating preclinical data to human populations / M.N. Martinez -- Pharmacokinetics/ADME of small molecules / A.D. Ajavon and David R. Taft -- Pharmacokinetics/ADME of large molecules / R. Braeckman -- Preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development / P.L. Bonate and P. Vicini -- Formulation and production strategies for enhancing bioavailability of poorly absorbed drugs / A.B. Watts and R.O. Williams III -- Transporters involved in drug disposition, toxicity, and efficacy / C.Q. Xia and G.T. Miwa -- Toxicity evaluations, ICH guidelines, and current practice / J.L. Larson -- Application of pathology in safety assessment / Robert A. Ettlin and David E. Prentice -- Utilizing the preclinical database to support clinical drug development / H. Lee.
Additional AuthorRogge, Mark C.
Taft, David R.
SubjectDrug development.
SeriesDrugs and the pharmaceutical sciences ; 187
Drugs and the pharmaceutical sciences ; v. 187.
Descriptionviii, 359 p., [8] p. of plates : ill. (some col.) ; 27 cm.
ISBN9781420084726 (hardcover : alk. paper)
1420084720 (hardcover : alk. paper)
WorldCat No.416216136

Cover Art
Building a national framework for the establishment of regulatory science for drug development : workshop summary - Yeonwoo Lebovitz, Rebecca A. English and Anne B. Claiborne
Call Number: Snell Stacks RM301.25 I564 2011
ISBN: 0309158893
BibliographyIncludes bibliographical references.
ContentsIntroduction -- Defining regulatory sciences -- The urgent need for regulatory science -- Barriers to enhanced regulatory science -- Potential models for building a regulatory science infrastructure -- Challenges in engaging the public policy community -- Envisioning successsful regulatory science at FDA -- Considering next steps.
Summary"The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it."--Publisher's description.
NoteAlso available online.
Additional AuthorLebovitz, Yeonwoo.
English, Rebecca A.
Claiborne, Anne B.
Other TitleRegulatory science for drug development
Forum on Drug Discovery, Development, and Translation
SubjectUnited States. Food and Drug Administration.
Drug development -- United States -- Congresses.
Descriptionxvi, 78 p. : col. ill. ; 23 cm.
ISBN0309158893
9780309158893
WorldCat No.681488332

Cover Art
Fundamentals of U.S. Regulatory Affairs
Call Number: Stacks KF1879 F86 2011
ISBN: 9780978700621
BibliographyIncludes bibliographical references and index.
Additional AuthorRegulatory Affairs Professionals Society.
Other TitleFundamentals of United States regulatory affairs
SubjectDrugs -- Law and legislation -- United States.
Biologicals -- Law and legislation -- United States.
Medical instruments and apparatus industry -- Law and legislation -- United States.
Descriptionviii, 460 p : ill. ; 28 cm..
ISBN9780982932124
098293212X
WorldCat No.754208639

Cover Art
Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines 2011
Call Number: Snell Library e-book
ISBN: 9781441974495
 
AccessLicensed for use by the entire Northeastern community including authenticated remote access.
NoteDescription based on print version record.
BibliographyIncludes bibliographical references and index.
SubjectDrugs -- Testing -- Safety regulations.
Medical instruments and apparatus -- Safety measures.
Medical instruments and apparatus -- Safety regulations.
Medical supplies industry -- Safety regulations.
Drugs -- Sterilization.
Pharmaceutical industry -- Quality control.
Pharmaceutical microbiology.
Medicine.
Science.
Pharmacy.
Natural history.
GenreElectronic books.
Description1 online resource (xi, 126 p.) : ill. (some col.)
Related ToPrint version: Gad, Shayne C., 1948- Safety evaluation of pharmaceuticals and medical devices. New York : Springer, 2011 9781441974488 1441974482 (OCoLC)692448825
ISBN9781441974495
1441974490
9781441974488
WorldCat No.694145938

Cover Art
Medical Product Regulatory Affairs: pharmaceuticals, diagnostics, medical devices
Call Number: Snell Library e-book
ISBN: 9783527623044
Publication Date: 2008

AccessLicensed for use by the entire Northeastern community including authenticated remote access.
BibliographyIncludes bibliographical references and index.
NoteDescription based on print version record.
Additional AuthorWalsh, Gary, Dr.
SubjectDrugs -- Law and legislation.
Pharmacy -- Law and legislation.
Medical instruments and apparatus -- Law and legislation.
GenreElectronic books.
Description1 online resource (xiii, 283 p.) : ill.
Related ToPrint version: Tobin, Jack (John J.). Medical product regulatory affairs. Weinheim : Wiley-Blackwell, c2008 9783527318773 3527318771 (OCoLC)220010794
ISBN9783527623044 (electronic bk.)
3527623043 (electronic bk.)
6611947108 (electronic bk.)
9786611947101 (electronic bk.)
3527318771 (Cloth)
WorldCat No.283799106
 


 

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