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Pharmacokinetic/Pharmacodynamic Modeling in Drug Research and Development
Author(s) -
Derendorf Hartmut,
Lesko Lawrence J.,
Chaikin Philip,
Colburn Wayne A.,
Lee Peter,
Miller Raymond,
Powell Robert,
Rhodes Gerald,
Stanski Donald,
Venitz Jürgen
Publication year - 2000
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/009127000004001211
Subject(s) - pharmacokinetics , pharmacodynamics , pharmacology , drug , drug development , dosing , medicine , clinical pharmacology , computational biology , biology
The two domains in clinical pharmacology dealing with optimizing dosing recommendations are pharmacokinetics and pharmacodynamics. However, the usefulness of these disciplines is limited if viewed in isolation. Pharmacokinetic/pharmacodynamic (PK/PD) relationships and modeling builds the bridge between these two classical disciplines of clinical pharmacology. It links the concentration‐time profile as assessed by pharmacokinetics to the intensity of observed response as quantified by pharmacodynamics. Thus, the resulting so‐called integrated PK/PD‐models allow the description of the complete time course of the desired and/or undesired effects in response to a drug therapy. PK/PD‐modeling can elucidate the causative relationship between drug exposure and response and provide a better understanding of the sequence of events that result in the observed drug effect. This information can then be used to streamline the drug development process and dose optimization. This consensus paper presents an update on the current state of PK/PD‐modeling from an academic, industrial and regulatory perspective.