PK/PD-modeling is applied in the pre-clinical and drug development stages, and its analysis of data will be beneficial to drug development. In addition, the concepts of PK/PD will provide a more rational basis for patient-specific individualization treatment and thus may guide applied pharmacotherapy to a higher level of performance in clinical treatment.
PK/PD analysis and modeling can be applied both in the pre-clinical and clinical stage. During drug development, they will provide valuable support to make important decisions. Our following services are provided for PK/PD analysis and modeling at different stages of drug development (Figure 1):
Figure 1. The steps of PK/PD-modeling.
Phase I studies provide initial human data for the tested compound and include a small number of short studies in healthy subjects or patients. They provide early data on human tolerability, PK and sometimes PD.
Phase II includes studies in carefully selected patients from the patient population of interest. They provide data across a dose range and help to assess a dose–response relationship.
Phase III studies provide the final confirmation of the efficacy and safety of the tested drug in a wide patient population of interest. They provide the ultimate safety and efficacy data for the approval of drug’s use in clinical practice.
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References: 1. Rajman, I. (2008) ‘PK/PD modelling and simulations: utility in drug development.’ Drug Discovery Today, 13(7), 341-346. 2. Derendorf, Hartmut, and B. Meibohm. (1999) ‘Modeling of Pharmacokinetic/Pharmacodynamic (PK/PD) Relationships: Concepts and Perspectives.’ Pharmaceutical Research, 16(2), 176-85. 3. Karlsson, Mats O., et al. (2005) ‘Pharmacokinetic/Pharmacodynamic Modelling in Oncological Drug Development.’ Basic & Clinical Pharmacology & Toxicology, 96(3), 206-211.