Literature DB >> 22315018

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

Walter W Hauck.   

Abstract

At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines and foods. The relationship of these monographs and reference materials, one to another, frequently is inconsistently understood and documented.This article considers the complexity of monographs and reference materials with a focus on qualifying one reference material relative to another.

Mesh:

Substances:

Year:  2012        PMID: 22315018     DOI: 10.1007/s11095-012-0687-7

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


  3 in total

1.  Measurement science for food and drug monographs: toward a global system.

Authors:  William F Koch; Walter W Hauck; Susan S de Mars; Roger L Williams
Journal:  Pharm Res       Date:  2010-04-06       Impact factor: 4.200

2.  The value of USP public standards for therapeutic products.

Authors:  L Bhattacharyya; T Cecil; R Dabbah; D Roll; S Schuber; E B Sheinin; R L Williams
Journal:  Pharm Res       Date:  2004-10       Impact factor: 4.200

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

Authors:  David M Dudzinski
Journal:  Food Drug Law J       Date:  2005       Impact factor: 0.619

  3 in total
  1 in total

Review 1.  Role of public standards in the safety and efficacy of biologic medicines.

Authors:  Roger L Williams; Adrian F Bristow; Walter W Hauck; V Srini Srinivasan; Tina Morris; Fouad Atouf; Michael Ambrose; Koduru V Surendranath; Ranjan Chakrabarty; Krishna Menon
Journal:  AAPS J       Date:  2014-04-02       Impact factor: 4.009

  1 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.