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Мурашев Аркадий Николаевич PowerPoint PPT Presentation


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ОПЫТ ОРГАНИЗАЦИИ И ПРОВЕДЕНИЯ ДОКЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ НА БАЗЕ ЛАБОЛАТОРИИ БИОЛОГИЧЕСКИХ ИСПЫТАНИЙ ФИЛИАЛА ИБХ РАН В СООТВЕТСТВИИ С ПРАВИЛАМИ GLP. Мурашев Аркадий Николаевич. Лаборатория биологических испытаний ФИЛИАЛ ИНСТИТУТА БИООРГАНИЧЕСКОЙ ХИМИИ

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Мурашев Аркадий Николаевич

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5739944

GLP

.. ..


5739944

( , 267 19 2003 .)

Good Laboratory Practice for Nonclinical Laboratory Studies(FDA, 21 CFR Part 58, 22 1978 .)

OECD Principles on Good Laboratory Practice(OECD, ENV/MC/CHEM(98)17, 1997 .)


5739944

GLP FDA

58.31 (Testing facility management)

58.33 (Study director)

58.35 (Quality assurance unit)

58.29 (Personnel)

58.43 (Animal care facilities)

58.49 (Laboratory operation areas)

58.61 (Equipment design)

58.90 (Animal care)

58.107 (Test and control article handling)

58.81 (Standard operating procedures)

58.120 (Protocol)

58.185 (Reporting of nonclinical laboratory study results)

58.130 (Conduct of a nonclinical laboratory study)

58.190 (Storage and retrieval of records and data)


5739944

(GLP) " " N 86- 22.06.1998

,


5739944

GLP

TESTING FACILITY MANAGEMENT

STUDY DIRECTOR

QUALITY ASSURANCE UNIT


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[email protected]

www.fibkh.serpukhov.su


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