Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

On the Development and Application for Marketing Authorizations for Antidotes for the Treatment of Intoxications with Organophosphates and Nerve Agents

Dr. Carsten Kratzsch (Abschlußjahr: 2010)

Language: English

Antidotes for the treatment of intoxications with organophosphates and nerve agents moved more and more out of the focus of both developers and the pharmaceutical industry since during the late 20th century the dangers of intoxications by organophosphate pesticides as well as the threat of large scale chemical warfare scenarios continuously decreased.

However, as illustrated by several terrorist attacks (e.g. Japan and Afghanistan) employing pesticides from the organophosphate group or even classical nerve agents, the danger persists and might even increase in the future due to dissemination of material and knowledge.

Therefore, a renewed interest in those products by military forces as well as civil defense agencies sparked new developments in this medical field.

As there have been none or very few innovations in the field of medical countermeasures (MCM) for the treatment of intoxications with organophosphates or nerve agents and other CWs, there is little knowledge on the regulatory and developmental requirements for such products.

Antidotes are drugs / medicinal products as any other drugs and therefore are subject to the dynamic field of regulatory affairs.

In this thesis, various possible approaches to the process of developing, testing and assembling a dossier for a novel antidote in order to finally obtain a marketing authorization (MA) are discussed.

Some theoretical information on the mechanism of action and toxicity of OPs and nerve agents as well as the available treatment options and antidotes are given.

Furthermore, specific aspects that might arise during the planning, development, trial and authorization phases of a novel antidote product are analyzed as well as various possible regulatory strategies. Finally, the necessary pharmaceutical-technical, non-clinical and clinical development programs are examined, laying special focus on the problems concerning the feasibility of performing full-scale clinical trials as well as specific aspects concerning the target population for the antidotes as well as pediatric concerns.

Pages: 65, Annexes: 0