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PROJECT-ORIENTED APPROACH TO FINISHED PHARMA PRODUCT DEVELOPMENT IN THE CONTEXT OF GENERIC POLYCOMPONENT DRUG CONTAINING AMOXYCILLIN AND CLAVULANIC ACID

Abstract

During steps of drug development area determination the decision area was framed providing isolation observed work activities from operating activities in order to set task achievement in specified time. Represented in the present paper approach to process analysis and implementation (including product development and lifecycle) characterized high level of concerned person involvement and high efficiency.

About the Author

Yu. V. Vlasenko
LLC «МК Development»
Russian Federation


References

1. Федеральный закон от 12.04.2010 № 61-ФЗ (ред. от 29.12.2015) «Об обращении лекарственных средств».

2. ГОСТ Р ИСО 21500-2014. Руководство по проектному менеджменту. - М.: Стандартинформ, 2015.

3. ICH M4Q. The common technical document / International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. 2002.

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5. Государственная фармакопея Российской Федерации, XIII издание. - М.: Министерство здравоохранения Российской Федерации, 2015.


Review

For citations:


Vlasenko Yu.V. PROJECT-ORIENTED APPROACH TO FINISHED PHARMA PRODUCT DEVELOPMENT IN THE CONTEXT OF GENERIC POLYCOMPONENT DRUG CONTAINING AMOXYCILLIN AND CLAVULANIC ACID. Drug development & registration. 2016;(1):30-36. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)