신경작용제 해독제 의약품 품목허가 사례 연구 = A Case Study on the FDA Approval of Medical Treatments against Nerve Agent Poisoning

다국어 초록 (Multilingual Abstract)

The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

참고문헌 (Reference)

1 "http://www.samyangchem.com"

2 "http://www.meridianmeds.com"

3 "http://www.fda.org"

4 Shih, T.-M., "Time Course Effects of Soman on Acetylcholine and Choline Levels in Six Discrete Areas of the Rat Brain" 78 : 170-175, 1985

5 Dretchen, K. L., "Protection by Phenytion and Calcium Channel Blocking Agents Againsts the Toxicity of Diisopropylfluorophosphate" 83 : 584-589, 1986

6 LTS Lohmann Therapie-System AG, "Prophylactic Transdermal Device Against Nerve Agent" 2002

7 Dunn, M. A., "Progress in Medical Defence Against Nerve Agents" 262 : 649-652, 1989

8 Berman, H. A., "Kinetic, Equilibrium, and Spectroscopic Studies on Dealkylation (‘aging’) of Alkyl Organophosphonyl Acetylcholinesterase" 261 : 10646-10652, 1986

9 O. Napoleon Monroe, "Dispersion Multichamber Auto-Injector"

10 Kim, Y.-B., "Clinical Considerations the Use of Pyridostigmine" D91-D101, 1999

11 Lim, D. K., "Changes in ACh Levels in the Rat Brain During Subacute Administration of Diisopropyl Fluorophosphate" 90 : 477-489, 1987

12 Rickett, D. J., "Central Respiratory Effects Versus Neuromuscular Actions of Nerve Agents" 7 : 225-236, 1986

13 Loomis, T. A., "Antidotal Action of Pyridinium Oximes in Anticholinesterase Poisoning ; Comparative Effects of Soman, Sarin, and Neosigmine on Neuromuscular Function" 5 : 685-701, 1963