Voluntary Standards for the Operation of Clinical Pharmacology Units

Abstract

Clinical Pharmacology Units (CPUs) are a special class of clinical research units for investigating the pharmacokinetic, pharmacodynamic, and toxicologic properties of drugs in man. The Association of Clinical Pharmacology Units (ACPU) is a national professional society with a membership drawn from academic and in-house pharmaceutical industry CPUs. It was established to provide a forum facilitating cooperation and the exchange of information and ideas between CPUs. One of its major objectives has been to promote the establishment of voluntary minimum standard of practice and guidelines for clinical pharmacology units.

In October 1992, ACPU's Standards Committee undertook to draft a set of principles which would guide CPUs in the development of local standards and procedures. The product of this work was adopted by the membership in October 1994 after several review and revision cycles. ACPU invites comments from the clinical research community concerning its Voluntary Standards for the Operation of Clinical Pharmacology Units.