Regulatory challenges for new formulations of controlled substances in today's environment.

Abstract:

:The pharmaceutical industry has made substantial innovations in the area of targeted drug delivery and optimization of pharmacokinetics for existing drugs to try to maximize therapeutic effect while simultaneously minimizing adverse consequences of medication abuse. These innovations, however, have not come without a price. Designer drugs and high content modified release formulations have been exploited both in casual recreational drug abuse as well as, on a much larger scale, by the criminal diversion of these products for profit. In this paper we will consider the challenges before manufacturers and regulators as they approach the problem of abuse potential of these new drug products and some of the solutions specifically designed to counteract abuse.

journal_name

Drug Alcohol Depend

authors

McCormick CG

doi

10.1016/j.drugalcdep.2006.02.001

keywords:

subject

Has Abstract

pub_date

2006-06-01 00:00:00

pages

S63-7

eissn

0376-8716

issn

1879-0046

pii

S0376-8716(06)00054-8

journal_volume

83 Suppl 1

pub_type

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