Jump to content

We're sorry for technical difficulties latest site upgrade caused.

We have now resolved the issue. 

If you're still experiencing issues, please clear your cache by following instructions on this link.  
Shall the issue persist after this step, welcome report it. 

Sign in to follow this  
Rahuls99

Biosimilars Regulatory, Clinical, and Biopharmaceutical Development

Recommended Posts


1901140444040098.jpg
Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (AAPS Advances in the Pharmaceutical Sciences Series, Book 34) by Hiten J. Gutka and Harry Yang
English | 2018 | ISBN: 3319996797 | 709 pages | PDF | 11,7 MB



This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
For the ease of readers, the book comprises of six sections as follows:
Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars
Section II: Regulatory Aspects of Development and Approval for Biosimilars
Section III: Biopharmaceutical Development and Manufacturing of Biosimilars
Section IV: Analytical Similarity Considerations for Biosimilars
Section V: Clinical aspects of Biosimilar Development
Section VI: Biosimilars- Global Development and Clinical Experience
Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.


Buy Premium From My Links To Get Resumable Support,Max Speed & Support Me
[b]Download (Uploadgig)[/b]
https://uploadgig.com/file/download/815a511aDf6F123f/dmpvg.Biosimilars.Regulatory.Clinical.and.Biopharmaceutical.Development.rar
Download ( Rapidgator )
https://rapidgator.net/file/e6cea98a357e31ea355a78c10882e0c5/dmpvg.Biosimilars.Regulatory.Clinical.and.Biopharmaceutical.Development.rar
Download ( NitroFlare )
http://nitroflare.com/view/D57CD46B0280C03/dmpvg.Biosimilars.Regulatory.Clinical.and.Biopharmaceutical.Development.rar

Share this post


Link to post
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Sign in to follow this  

Elite7Hackers Netwok

Hack the imagination!

Support and inquiries

Open support ticket here or email us at [email protected]

Highlights

Highlighted/recommended lights

×
×
  • Create New...

Important Information

By using this site, you agree to our Privacy Policy and Terms of Use.