Details

Autor(en) / Beteiligte

• Owen, Joel S
• Fiedler-Kelly, Jill
• Fiedler‐Kelly, Jill

Titel

PK/PD Models

Ist Teil von

• Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models, 2014, p.250-264

Ort / Verlag

United States: John Wiley & Sons, Incorporated

Erscheinungsjahr

2014

Quelle

Wiley Online Library All Obooks

Beschreibungen/Notizen

• As an introduction to pharmacokinetics (PK)/pharmacodynamics (PD) modeling with NONMEM, this chapter focuses primarily on typical PD models of continuous data. For more complex PK or PD models, the general ADVANs (i.e., ADVAN5–9 or ADVAN13) may be used. The chapter considers examples of each of these approaches. A broader use of PK/PD models is to balance models of PD response for both safety and efficacy in a clinical utility model to quantitate the benefit versus risk profile and optimize dose selection. The evaluation of a candidate product can be enhanced through such quantitative approaches. The methods introduced in the chapter are some of the building blocks for such models. The issue of communication is brought up briefly in this chapter on PK/PD models since this is an area of modeling which frequently addresses the critical clinical issues of safety and efficacy.