Nonclinical - often referred to as preclinical - services encompass toxicology, pharmacology, metabolism, bioanalysis, pharmaceutical analysis, and biosafety testing in support of nonclinical drug development. Nonclinical testing is conducted throughout all phases of drug development. Sound nonclinical development maximizes the chances of success in the clinical phases. CCDRD offers comprehensive services in all of these areas within the broad context of a thorough understanding of the regulatory, scientific, and commercial environments.

		Top

		Top

The focus of bioanalysis is to provide a quantitative measure of the active drug and/or its metabolites. Samples may be derived from cell culture media or from plasma, serum, or urine. Bioanalytical services range from late discovery to clinical studies. Depending on the chemical nature, the molecular weight and structure of the drug, the level of the drug/metabolite, and the matrix (serum, plasma, urine, or culture media), an appropriate bioanalytical technique is required. CCDRD AG provides a broad range of Bioanalytical services from standalone chromatographic techniques to mass spectrometry techniques as well as immunochemical methods.

Services include:

• Method feasibility, development, and validation
• Nonclinical/toxicokinetic analysis
• Clinical/pharmacokinetic analysis

		Top

		Top