Design and analysis of bridging studies (2013) Pdf Free Download

In this blog post, you can download Design and analysis of bridging studies (2013) for free in PDF format download with one click.

Overview of Design and analysis of bridging studies (2013) PDF free download:

We take user experience very seriously at and are constantly striving to improve. You can easily find other medical related books from here. We hope you find our blog to be helpful.

Before we share the free PDF download of Design and analysis of bridging studies (2013) pdf Free download with you, here are a few important details about this book in case you're interested.

You might also be interested in: 

First Aid for the USMLE Step 1 2023 pdf free download

United State Pharmacopeia 46 - NF 41 (USP 2023 pdf)

British Pharmacopoeia 2023 (BP-23) pdf free download

Features of Design and analysis of bridging studies (2013) PDF free download:


In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors have become a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for product development. To address this issue, a general framework has been provided by the International Conference Harmonisation (ICH) E5 in a document titled “Ethnic Factors in the Acceptability of Foreign Clinical Data” for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide
pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region.
However, a bridging study may require significant development resources and also delay availability of the tested medical product to the needing patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Recently, the trend for clinical development in Asian countries being undertaken simultaneously with clinical trials conducted in Europe and the United States has been rapidly rising.

Download Link 1

{getButton} $text={Download Design and analysis of bridging studies (2013)} $icon={download} $color={Hex Color}

Download Link 2

{getButton} $text={Download Design and analysis of bridging studies (2013)} $icon={download} $color={Hex Color}


This site complies with DMCA digital copyright laws. Please note that we do not own the rights to this book / software. We do not host copyrighted content on our servers, it is a catalog of links already found on the Internet. does not contain any server-hosted material on this site, only links to books taken from other websites are published here, and these links are not linked to the book server. 

In addition, does not store any books, guides, software, or images. No illegal copies are made or there is no infringement or copyright infringement © and/or copyrights because all material is free on the Internet. See our DMCA policy. If you believe we have infringed your copyright, please contact us directly. We share them with our audience for educational purposes ONLY and strongly encourage our visitors to purchase original software/books and licenses.  {alertInfo}


If the copyright holder wants us to remove this software / book, please contact us. You can send an email to for any DMCA / removal requests. {alertSuccess}


Post a Comment

Previous Next

نموذج الاتصال