Implementation of New Test Methods into Practical Testing

Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 856)


New toxicology test methods, especially those using in vitro methods, are continually being developed. Some are used by industry for screening purposes; others are eventually validated for regulatory use. However, for a new test method to be firmly adopted by industry it must be readily available, generally through an in-house industry laboratory, an academic laboratory, or a contract research organization. Regardless of the type of laboratory which intends to implement the test method, certain steps must be taken to ascertain that the method that is put into place is reproducible and performs identically to the test method that was published or has undergone validation. This involves developing protocols and standard operating procedures, training staff, developing historic positive and negative control data, establishing acceptable performance with proficiency chemicals, and addressing all the safety concerns that may accompany the assay. From experience within a contract research laboratory, we provide guidance on how to most efficiently accomplish these tasks.


In vitro Test methods Toxicology testing GLPs OECD Test Guidelines 



The authors would like to thank Dr. Gertrude-Emilia Costin of IIVS for her careful review of the manuscript and her constructive comments.


  1. Bruner L, Carr G, Chamberlain M, Curren R (1996) No prediction model, no validation study. Altern Lab Anim 24:139–142Google Scholar
  2. Centers for Disease Control (1988) Perspectives in disease prevention and health promotion update: Universal precautions for prevention of transmission of human immunodeficiency virus, Hepatitis B virus, and other bloodborne pathogens in health-care settings. In: MMWR: Morb Mortal Wkly Rep. Accessed 7 Jan 2016
  3. Curren R, Southee J, Spielmann H, Liebsch M, Fentem J, Balls M (1995) The role of prevalidation in the development, validation and acceptance of alternative methods. Altern Lab Anim 23:211–217Google Scholar
  4. European Food Safety Authority (2012) Successful EU response to BSE. Accessed 7 Jan 2016
  5. Freshney RI (2016) Culture of animal cells: a manual of basic technique and specialized applications. Wiley, New YorkGoogle Scholar
  6. Hayashi M, Dearfield K, Kasper F, Lovell D, Martus H, Thybauld V (2011) Compilation and use of genetic toxicology historical control data. Mutat Res 723:87–90CrossRefPubMedGoogle Scholar
  7. Karkalousos P, Evangelopoulos A (2011) Quality control in clinical laboratories. In: Ivanov O (ed) Applications and experiences in quality control. Intech, RijekaGoogle Scholar
  8. Mortelmans K, Zeiger E (2000) The Ames Salmonella/microsome mutagenicity assay. Mutat Res 455(1–2):29–60CrossRefPubMedGoogle Scholar
  9. Norman K (2014) Cosmetic safety assessments in the 21st century. Specialty Chemicals Magazine. p 22–23Google Scholar
  10. Organisation for Economic Co-operation and Development (2014) In vitro skin corrosion: reconstructed human epidermis (Rhe) test method. Accessed 7 Jan 2016
  11. Organisation for Economic Co-operation and Development (2015a) OECD guidelines for the testing of chemicals. Accessed 7 Jan 2016
  12. Organisation for Economic Co-operation and Development (2015b) Series on testing and assessment: testing for human health. Accessed 7 Jan 2016
  13. Sivak JG, Herbert KL, Segal L (1994) Ocular lens organ culture as a measure of ocular toxicity: the effect of surfactants. Toxicol Meth 4:56–65CrossRefGoogle Scholar
  14. U.S. Environmental Protection Agency (2011) Pesticide Registration (PR) Notice 2011-3, Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Accessed 7 Jan 2016

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Institute for In Vitro Sciences, Inc.GaithersburgUSA
  2. 2.Eurofins BioPharma Product TestingMunichGermany

Personalised recommendations