Literature DB >> 16094771

Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies.

David M Dudzinski.   

Abstract

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Year:  2005        PMID: 16094771

Source DB:  PubMed          Journal:  Food Drug Law J        ISSN: 1064-590X            Impact factor:   0.619


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  5 in total

1.  Primary and secondary reference materials for procedures to test the quality of medicines and foods.

Authors:  Walter W Hauck
Journal:  Pharm Res       Date:  2012-04       Impact factor: 4.200

2.  European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK.

Authors:  Janice M Reichert; Alain Beck; Harish Iyer
Journal:  MAbs       Date:  2009-09-25       Impact factor: 5.857

Review 3.  Polyionic vaccine adjuvants: another look at aluminum salts and polyelectrolytes.

Authors:  Bradford S Powell; Alexander K Andrianov; Peter C Fusco
Journal:  Clin Exp Vaccine Res       Date:  2015-01-30

4.  Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

Authors:  Kelly George; Gillian Woollett
Journal:  BioDrugs       Date:  2019-10       Impact factor: 5.807

5.  Trends in US approvals: new biopharmaceuticals and vaccines.

Authors:  Janice M Reichert
Journal:  Trends Biotechnol       Date:  2006-06-06       Impact factor: 19.536

  5 in total

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