Abstract
A questionnaire designed to elicit the nature of registration packages of a “standard pharmaceutical” was circulated worldwide. The responses received from a significant number of pharmaceutical companies (36 European, 15 American, and 44 Japanese) indicated significant differences in the monitoring of toxicology studies by the determination of circulating drug levels—the practice of toxicokinetics. This is a routine feature of regulatory packages in the West but at the moment, is not common in Japanese practice.
Get full access to this article
View all access options for this article.