PRECLINICAL GLP SERVICES

 

Test Item Characterization, Dose Verification, Stability and Homogeneity in support of GLP Preclinical Toxicology

Compliance with the principles of GLP (Good Laboratory Practice) is a legal requirement for test facilities that undertake non-clinical safety and toxicology studies intended for submission. The OECD (Organisation for Economic Co-operation and Development) Principles of GLP require test items to be characterized (ref. ENV/MC/CHEM(98)17). The homogeneity, stability and concentration of the test item in the vehicle should be determined. Consequently, this information should be generated as part of a GLP study if the study director intends to make a full claim of GLP compliance.

 

Short-term in vitro studies

  • Ames (Mutagenicity)
  • Cytotoxicity (XTT assay)

 

Pre- and clinical PK and TK analysis

Analysis of biological samples with main techniques such as LC-MS/MS for small molecules and ELISA for large molecules. We can provide method transfer or full method development and validation services including procurement of adequate isotopically labeled internal standards.

 

Preclinical Toxicology Studies 

Full IND/NDA, ANDA, BLA and IMP enabling programs are available through our global services in cooperation with Nelson Labs Europe. An overview of standard study designs can be found here. Of course, we are very flexible in further customizing the design in order to meet your requirements. The in vivo portion of the study will always be conducted in the US, whereas in Europe we focus on the analytical portions.  Therefore, we have developed and implemented procedures to conduct GLP multi-site studies, which address both OECD GLP and FDA CFR part 58 compliance. 

For Proof-of-Concept testing of your compound against Cancer, Inflammatory Diseases, diabetes and Obesity, Ocular Diseases, ...please check our experience with following disease models.


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Contact:

 

Kevin Breesch, MSc
Manager Business Development International Preclinical

kbreesch@nelsonlabs.com

Nelson Labs Europe | Preclinical GLP Services
LC-MS/MS
LC-MS/MS