Pre-Clinical Services   >  Toxicology

Non-GLP toxicology studies are intended to provide preliminary assessment of a drug’s safety. Non-GLP toxicology studies can be performed on research grade materials to reduce costs and promote study design flexibility. These early stage studies can be performed prior to committing to the substantial costs in time and financial resources required to producing GMP grade material.

GLP toxicology studies are required as a prerequisite for filing an IND package and are normally performed only on GMP produced material prior to phase-I clinical trials. GLP-compliant regulatory tests are mandated for marketing approval. Toxicity Studies available include:

•     Single Dose Range Finding and Acute Toxicity Studies
•     Repeated Dose (28/90/180) Toxicology Studies
•     Carcinogenicity
•     Systemic and Local Toxicology
•     LD-50 and Maximum Tolerated Dose (MTD) Determination.
•     Genotoxicity (Invitro & Invivo Mutagenicity)
•     Male & Female Fertility Studies
•     PK/PD, ADME (I.V./Bolus, Abs.B.A)
•     Prenatal Development (2 generation)



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