spacer
home > epc > autumn 2008 > be alternative
PUBLICATIONS
European Pharmaceutical Contractor

Be Alternative

In preclinical drug development, in vitro studies are establishing themselves in a more prominent position. Because of ethical considerations, an increasing number of in vivo tests have been replaced by in vitro experiments. These tests are recommended by organisations such as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and (draft) Test Guidelines are accepted or sent for consideration to the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and the Organization of Economic Cooperation and Development (OECD), which are all part of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH).

The National Institutes of Health (NIH) and other federal agencies are committed to the welfare of research animals. These animals are protected by law, regulations and policies to ensure that companies are sued as rarely as possible and with special care taken in order to ensure animals’ comfort. Alternative test methods are those that accomplish one or more of the three ‘Rs’:

  • Reducing the number of animals used in testing through improved science and experimental design
  • Refining experimental procedures so that animals experience less pain and distress
  • Replacing animals with non-animal systems where possible

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Natalie MGM Appels obtained her Masters degree in Biopharmaceutical Sciences from the University of Leiden in 1998. Her career as a research scientist began at the spin-off company ScreenTec BV currently known as Kiadis BV. She received her PhD from the Netherlands Cancer Institute. Since 2006, she has been employed by NOTOX BV as a Study Director in the In Vitro ADME section.

Ilona Verbaan-Giebelen obtained her Masters degree in Medical Biology from the Free University of Amsterdam in 1999. She has worked as a Research Technician at Organon NV and received her PhD from the Centre for Experimental and Molecular Medicine at the Academic Medical Centre in Amsterdam. She joined NOTOX BV in 2008 as Study Director, Genetic and In Vitro Toxicology.

spacer
Natalie MGM Appels
spacer
spacer
spacer
Ilona Verbaan-Giebelen
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals receives FDA approval

[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >>

White Papers

Faster, Better, Cheaper: Lean as a Driving Force Behind Pharmaceutical Companies’ Growth

TBM Consulting Group

The pharmaceutical industry faces countless challenges: patent expirations, weak product development pipelines, downward pricing pressure and an increasingly burdensome regulatory environment. The most important question for companies is now “How can we position ourselves optimally to be successful in the long term?” Some pharmaceutical companies used the economic downturn in 2009 to embrace measures in the fields of cost reduction and efficiency increases, which can be implemented at short notice. The continuous and consistent implementation of sustainable measures that guarantee stability and form the basis for future growth was not necessarily paramount within this.
More info >>

 
Industry Events

CPhI Worldwide

5-7 November 2019, Frankfurt, Germany

Join the World's Largest Pharma Event As it Celebrates its 30th Anniversary! Taking place from 5-7 November 2019 in Frankfurt, Germany, the event will bring together more than 45,000 visiting pharma professionals from around the globe and over 2,500 exhibiting pharma companies from every stage of the pharmaceutical supply chain - from ingredients and machinery to outsourcing services, packaging and more!
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement