How We Can Support the Drug Development Pipeline

PreClinical Testing

The main goal of pre-clinical studies before administration of a new drug to humans, is to determine its safety profile. Most pre-clinical studies must adhere to Good Laboratory Practices (GLP) to be acceptable for submission to regulatory agencies such as the Food & Drug Administration (FDA) in the United States.

The  FDA have prepared guidelines on the type of data required for the Investigational New Drug (IND) application. IND enabling studies are integral to the IND package and must be completed and included in the submission.

Source BioScience is a fully accredited GLP facility experienced in supporting FDA submission and cross reactivity studies.

Since nearly 50% of drugs fail due to metabolic instability or inability to metabolise, SourceBioScience offers CYP testing using Roche P450 as well as ABI DME SNPs.

We also offer cross reactivity testing in tissue using FDA and FDA/European lists including IHC ,FISH analysis together with expert pathology review for a range of small molecules and NDEs providing a comprehensive range of tests to meet our client needs.