Bioequivalence

Handbook of Bioequivalence Testing, Second Edition  

Posted by interes at Nov. 5, 2014
Handbook of Bioequivalence Testing, Second Edition

Handbook of Bioequivalence Testing, Second Edition (Drugs and the Pharmaceutical Sciences) by Sarfaraz K. Niazi
English | 2014 | ISBN: 1482226375 | 1007 pages | PDF | 15 MB

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.

Generic Drug Product Development: Bioequivalence Issues  

Posted by ChrisRedfield at July 19, 2015
Generic Drug Product Development: Bioequivalence Issues

Leon Shargel - Generic Drug Product Development: Bioequivalence Issues
Published: 2007-11-15 | ISBN: 0849377846 | PDF | 288 pages | 3.43 MB
Handbook of Bioequivalence Testing, Second Edition (repost)

Handbook of Bioequivalence Testing, Second Edition (Drugs and the Pharmaceutical Sciences) by Sarfaraz K. Niazi
English | 2014 | ISBN: 1482226375 | 1007 pages | PDF | 15 MB
Bioequivalence Studies in Drug Development: Methods and Applications by Volker Steinijans

Bioequivalence Studies in Drug Development: Methods and Applications by Volker Steinijans
English | Feb 27, 2007 | ISBN: 0470094753 | 328 Pages | PDF | 5 MB

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence.
Bioequivalence and Statistics in Clinical Pharmacology (Chapman & Hall/CRC Biostatistics Series) by Byron Jones

Bioequivalence and Statistics in Clinical Pharmacology (Chapman & Hall/CRC Biostatistics Series) by Byron Jones
English | Nov 10, 2005 | ISBN: 1584885300 | 384 Pages | PDF | 4 MB

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how…
Topical Drug Bioavailability, Bioequivalence, and Penetration

Topical Drug Bioavailability, Bioequivalence, and Penetration by Vinod P. Shah and Howard I. Maibach
English | 2015 | ISBN: 1493912887 | 402 pages | PDF | 9 MB

FDA Bioequivalence Standards  

Posted by enmoys at Nov. 20, 2014
FDA Bioequivalence Standards

FDA Bioequivalence Standards By Lawrence X. Yu, Bing V. Li
2014 | 472 Pages | ISBN: 1493912518 | PDF | 7 MB

Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics  eBooks & eLearning

Posted by Underaglassmoon at April 15, 2016
Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics

Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches, Second Edition
Springer | Interdisciplinary Applied Mathematics | April 15, 2016 | ISBN-10: 3319275968 | 483 pages | pdf | 9.46 mb

Authors: Macheras, Panos, Iliadis, Athanassios
Updated state-of-the-art information on biopharmaceutic, pharmacokinetic, and pharmacodynamic modeling
New chapters on Bioequivalence and Fractional Pharmacokinetics, contributed by leaders in the field
New sections on time-varying models and interface models
Appeals to both graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology
Covers the theory with specific examples behind all three under the perspective of heterogeneous processes while also treating the current state of the art in applied and theoretical BPP
Statistical Tools for Measuring Agreement by Lawrence Lin

Statistical Tools for Measuring Agreement by Lawrence Lin
English | Oct. 18, 2011 | ISBN: 1461405610 | 173 Pages | PDF | 1 MB

Agreement assessment techniques are widely used in examining the acceptability of a new or generic process, methodology and/or formulation in areas of lab performance, instrument/assay validation or method comparisons, statistical process control, goodness-of-fit, and individual bioequivalence.