Safety Pharmacokinetics: Introduction

Reference work entry

Abstract

As already stated in the introduction of the first edition, no toxicology or safety pharmacology assays are conceivable without a pharmacokinetic evaluation. If we talk about safety, we urgently need to know the exposure either of the animals used for safety studies or of the patients in clinical studies. It is common to talk about PK/PD, describing the relationship between Pharmacokinetics and pharmacodynamic efficacy, but in fact PK/Safety, describing the relationship between Pharmacokinetics and Safety, is at least as important. It is becoming ever more important since there is a clear tendency at the Regulatory Agencies to focus more and more on safety aspects—and those must always be linked to data about the individual exposures.

Keywords

Clinical Study Basic Principle Regulatory Agency Drug Disposition Safety Study 
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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.R&D Diabetes Division Leitung R&D FF Industriepark HöchstSanofi Deutschland GmbHFrankfurt am MainGermany

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