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Clinical

PHASE I PK ANALYSIS

DDC offers you our experience in Phase I protocol development and in the analysis and interpretation of Phase I clinical trial pharmacokinetic, bioavailability and bioequivalence data. We employ sophisticated computer modeling/simulation and SAS programs. DDC’s consultants are experienced in bioanalytical method development and in validation of pharmacokinetic support for all phases of clinical trials. This capability is combined with experience in developing methodology for the analysis and identification of drug metabolites.

DDC has experience in the evaluation and comparison of adult to child exposure for the development of pediatric drugs, and for assessing the bioavailability of controlled release products in comparison to an immediate release formulation.

For a Phase I trial, milestones include formulation, analytical and bioanalytical developments, initiation and completion of preclinical safety studies, and finally the development of a strategy to support the earliest date for this trial. Efficient timing is achieved by integrating the scheduling of a PreIND meeting and filing of an IND with the initiation of a First In Human (FIH) clinical trial.

DDC’s extensive experience with Contract Research Organizations (CROs) offers you recommendations for suitable CROs to conduct both nonclinical safety and Phase I studies.