Guest Editor's Note: Toxicokinetics—The Way Forward

Abstract

IT HAS LONG BEEN known that animals metabolize and excrete drugs faster than man and that safety comparison across and within species, using dosage, provides insufficient measures of relative exposure. Measurement of blood drug levels during toxicological studies (toxicokinetics), however, can provide a better appreciation of the total body load, but at the moment there are no regulatory guidelines to provide a framework for undertaking such studies for registration. In an attempt to rationalize this knowledge, it has been decided by those working for international harmonization that new guidelines should be drawn up and discussed at the forthcoming International Conference for Harmonization (ICH2). It was, therefore, felt opportune that the DIA should bring together scientists from industry, academia, and the regulatory agencies to address this new issue and hopefully provide support for the current discussions.A total of approximately 170 people listened to 35 speakers and chairmen from 14 countries over the two and one half days of the meeting which was held in Nice, France, February 24-26, 1993.All aspects of toxicokinetics were discussed with session themes dealing with:

Bioanalytical Method Development and Validation for the Estimation of Saxagliptin in Marketed Tablet Formulation

“…For example, pharmacokinetics (PK) is becoming more important in both processes [2,3]. Furthermore, toxicokinetics has established itself as an important component of toxicity testing [4,5]. With the increased emphasis on PK/toxicokinetic analysis and the increased potencies of novel medications, a sensitive and specific bioanalytical technique is required.…”