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Clinical Pharmacokinetic Studies

  • Axel Steinstraesser
  • Roland Wesch
  • Annke Frick
Reference work entry

Abstract

Drug efficacy and response are a function of drug concentration over time. In clinical pharmacokinetic studies, aspects of drug absorption, distribution, metabolism, and excretion over time are assessed. In the early clinical development, the pharmacokinetics of a drug is studied in healthy subjects followed by studies in patient population(s) with the aim to find the relevant dose in the target population(s). Particular pharmacokinetic studies in special populations assess the necessity of a dose adjustment from the planned/established clinical dose for patients.

Keywords

Hepatic Impairment Mean Residence Time Regular Human Insulin Insulin Glulisine Developmental Drug 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Abbreviations

Ae

Amount of drug excreted unchanged in urine

ANOVA

Analysis of variance

AUC

Area under the curve

BMI

Body mass index

C12,C24

Plasma concentration 12 and 24 h after administration

CI 90 %

90 % confidence Interval

CLCR

Creatinine clearance

CLR

Renal clearance

CLtot/F

Relative total clearance

Cmax

Maximum concentration

Cmax

Maximum plasma concentration

CV

Coefficient of variation

CYP3A4

Cytochrome P450 3A4

day –1

Study day prior to day of study medication administration

fu

Unbound fraction of XYZ123 in plasma

h

Hour

INN

International nonproprietary name

IU

International units

L

Liter

Mg

Milligram

MRT

Mean residence time

NPH

Neutral protamine Hagedorn (isophane insulin)

Rac

Accumulation ratio

RHI

Regular human insulin

s.c.

Subcutaneous(ly)

t1/2,λ1

Main elimination half-life

t1/2,λz

Terminal elimination half-life

t12t24

Time 12 and 24 h after administration

Tmax

Time to maximum concentration

tmax

Time to maximum plasma concentration

References and Further Readings

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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Axel Steinstraesser
    • 1
  • Roland Wesch
    • 1
  • Annke Frick
    • 1
  1. 1.Sanofi Deutschland GmbHFrankfurt am MainGermany

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