Handbook of Bioequivalence Testing

Download Handbook of Bioequivalence Testing PDF Online Free

Author :
Publisher : CRC Press
ISBN 13 : 1482226383
Total Pages : 1007 pages
Book Rating : 4.86/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Bioequivalence Testing by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1007 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

Handbook of Bioequivalence Testing

Download Handbook of Bioequivalence Testing PDF Online Free

Author :
Publisher : CRC Press
ISBN 13 : 0849383595
Total Pages : 602 pages
Book Rating : 4.95/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Bioequivalence Testing by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2007-08-22 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made

Handbook of Bioequivalence Testing, Second Edition

Download Handbook of Bioequivalence Testing, Second Edition PDF Online Free

Author :
Publisher : CRC Press
ISBN 13 : 1482226375
Total Pages : 1012 pages
Book Rating : 4.79/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Bioequivalence Testing, Second Edition by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing, Second Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Handbook of Dissolution Testing

Download Handbook of Dissolution Testing PDF Online Free

Author :
Publisher :
ISBN 13 : 9780943330228
Total Pages : 159 pages
Book Rating : 4.2X/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Dissolution Testing by : William A. Hanson

Download or read book Handbook of Dissolution Testing written by William A. Hanson and published by . This book was released on 1991 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dissolution testing is used in the pharmaceutical industry to determine a drug's bioavailability and the bioequivalence of two drugs. Hanson details the techniques used, and provides guidelines for starting and operating a program. First published "nearly ten years ago." Available from Aster Publishing Corporation, 859 Willamette Street, Eugene OR 97440. Annotation copyrighted by Book News, Inc., Portland, OR

Generic Drug Product Development

Download Generic Drug Product Development PDF Online Free

Author :
Publisher : CRC Press
ISBN 13 : 1420020021
Total Pages : 334 pages
Book Rating : 4.21/5 ( download)

DOWNLOAD NOW!


Book Synopsis Generic Drug Product Development by : Isadore Kanfer

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

Handbook of Pharmaceutical Manufacturing Formulations

Download Handbook of Pharmaceutical Manufacturing Formulations PDF Online Free

Author :
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.12/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Safaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Handbook of LC-MS Bioanalysis

Download Handbook of LC-MS Bioanalysis PDF Online Free

Author :
Publisher : John Wiley & Sons
ISBN 13 : 111867135X
Total Pages : 709 pages
Book Rating : 4.51/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of LC-MS Bioanalysis by : Wenkui Li

Download or read book Handbook of LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.

Handbook of Basic Pharmacokinetics-- Including Clinical Applications

Download Handbook of Basic Pharmacokinetics-- Including Clinical Applications PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 616 pages
Book Rating : 4.58/5 ( download)

DOWNLOAD NOW!


Book Synopsis Handbook of Basic Pharmacokinetics-- Including Clinical Applications by : Wolfgang A. Ritschel

Download or read book Handbook of Basic Pharmacokinetics-- Including Clinical Applications written by Wolfgang A. Ritschel and published by . This book was released on 1992 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Cochrane Handbook for Systematic Reviews of Interventions

Download Cochrane Handbook for Systematic Reviews of Interventions PDF Online Free

Author :
Publisher : Wiley
ISBN 13 : 9780470699515
Total Pages : 672 pages
Book Rating : 4.15/5 ( download)

DOWNLOAD NOW!


Book Synopsis Cochrane Handbook for Systematic Reviews of Interventions by : Julian P. T. Higgins

Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Preclinical Development Handbook

Download Preclinical Development Handbook PDF Online Free

Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470249021
Total Pages : 1352 pages
Book Rating : 4.24/5 ( download)

DOWNLOAD NOW!


Book Synopsis Preclinical Development Handbook by : Shayne Cox Gad

Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1352 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.