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Non-clinical drug development can be divided into three subsections:

(1) Early-phase R&D development of the drug substance as well as it´s drug product formulation
(2) Non-clinical development for which GLP is not required, and
(3) Non-clinical development which indeed should comply with GLP regulations. 

The European Medicines Agency (EMA) and the European Union provide different guidances for non-clinical development, depending on the type of therapeutic the applicant would like to develop:

(1) ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals.
(2) ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals [expressed in host organisms].
(3) ICH S9 Non-clinical evaluation for anticancer pharmaceuticals.
(4) REGULATION (EC) No 1394/2007 on advanced therapy medicinal products [ATMPs].

 

Accelero Bioanalytics supports your project at all development stages. Particularly with regards to the setup and validation of quantitative pharmacokinetic test methods, Accelero can add a value to your project by conducting:

  • Early pharmacology profiling in the course of the method setup
  • Pharmacokinetic profiling in dose range finding studies for single dose and/or repeated dose (no GLP is required);
  • Formulation analysis to support dose range finding studies (no GLP is required);
  • Toxicokinetic profiling in non-clinical repeated dose toxicology studies (GLP is required);
  • Formulation analysis to support toxicology studies (GLP is required);
  • Biodistribution qPCR studies of genetically modified therapeutics or cell-based therapeutics (GLP can be a requirement).

All test methods are validated according to the EMA Guideline on bioanalytical method validation, 21 July 2011.
EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2**
Accelero conducts validation studies in the spirit of the principles of Good Laboratory Practice (GLP). Test methods being applied for non-clinical pharmacology studies not required to be performed to GLP will be validated fit for purpose.

 

 

Last update of this site: 24-OCT-2016 by Christian Lange