Handbook of Bioequivalence Testing : Drugs and the Pharmaceutical Sciences - Sarfaraz K. Niazi

Handbook of Bioequivalence Testing

By: Sarfaraz K. Niazi

Paperback | 14 October 2024 | Edition Number 2

At a Glance

Paperback


RRP $96.99

$75.50

22%OFF

or 4 interest-free payments of $18.88 with

 or 

Available for Backorder. We will order this from our supplier however there isn't a current ETA.

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 approvalâ"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 costsâ"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.

Industry Reviews

"This handbook offers a complete description of every aspect of bioequivalence testing ... [It] is an essential, one-of-a-kind resource for anyone interested in bioequivalence. There are no other books that compile so many aspects in one place."
-Jennifer L. Colon, PharmD, Temple University School of Pharmacy, in Doody's Review Service

More in Biology, Life Sciences

Letters - Oliver Sacks

Paperback

$45.90

Principles of Anatomy and Physiology : 3rd Asia Pacific Edition - Gerard J. Tortora
Anatomy & Physiology For Dummies : For Dummies - Erin Odya

RRP $38.95

$26.35

32%
OFF
The Physiology Coloring Book : 2nd Edition - Esmail Meisami

RRP $41.95

$36.50

13%
OFF
A Guide to Native Bees of Australia - Dr Terry Houston

RRP $49.99

$40.50

19%
OFF
Netter's Anatomy Coloring Book : 3rd edition - John T. Hansen

RRP $37.95

$31.75

16%
OFF
The Anatomy Coloring Book - Wynn Kapit

RRP $31.96

$29.95

Gray's Anatomy for Students : 5th Edition - Richard Drake

RRP $154.95

$116.95

25%
OFF
Netter's Anatomy Flash Cards : 6th edition - John T. Hansen

RRP $73.95

$56.95

23%
OFF
Field Guide to the Native Plants of Sydney - Les Robinson

RRP $59.99

$39.75

34%
OFF
The Compact Australian Bird Guide - Jeff Davies

RRP $34.99

$33.25

A Field Guide to Australian Fungi - Bruce Fuhrer

RRP $49.95

$38.50

23%
OFF
Swainston's Fishes of Australia : The complete illustrated guide - Roger Swainston
First Knowledges Plants : Past, Present and Future - Zena Cumpston
AFN Australian Fish Guide : AFN Fish ID - Frank Prokop

RRP $29.99

$27.90