Preclinical testing analyzes the bioactivity, safety, and efficacy of the formulated product. It is essential to run
these preclinical studies for the application of an Investigational New Drug (IND). Studies taking place during the preclinical stage should be designed to support the clinical studies that will follow. BTS Research offers a complete range of services to support drug development and IND, NDA, and EPA submissions in small molecules, large molecules and biologics

Discovery

On average there are 5,000 to 10,000 molecules for each potential drug candidate. These molecules are subjected to a screening process from which, after careful review, one or more lead compounds are chosen.

Product Characterization

When the candidate molecule is chosen it must be characterized. Its size, shape, strengths and weaknesses, preferred conditions for maintaining function, toxicity, bioactivity, and bioavailability must be determined. Early stage pharmacology studies help characterize the underlying mechanism of action of the compound.

Formula, Delivery, Packaging Development

The proper drug delivery parameters must be met. This is determined by the drug’s stability in the formulation, and by all the parameters involved with storage and shipment, such as heat, light, and time. The formulation must remain potent and sterile; and it must also remain safe (nontoxic).

Pharmacokinetics and Drug Disposition

Pharmacokinetic or ADME (Absorption, Distribution, Metabolism and Excretion) studies provide useful information for the characterization of the molecule and its formulation. PK studies yield data such as AUC (area under the curve), Cmax (maximum concentration of the drug in blood), and Tmax (time at which Cmax is reached).

Preclinical Toxicology Testing and IND Application

Preclinical testing analyzes the bioactivity, safety, and efficacy of the formulated product. It is essential to run these preclinical studies for the application of an Investigational New Drug (IND). Studies taking place during the preclinical stage should be designed to support the clinical studies that will follow. BTS Research offers a complete range of services to support drug development and IND, NDA, and EPA submissions. BTS Research has standard protocols for many studies and is always adding custom protocols to accommodate your product needs. BTS Research is your GLP contract research organization of choice.