Guideline for good clinical practice - ich official web Description:
Guideline for good clinical practice ich harmonised tripartite guideline having reached step 4 of the ich process at the ich steering committee meeting.

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Good clinical practice handbook - national institute of

Division of microbiology and infectious diseases. may 2011. good clinical practice resource guide.

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Guideline on similar biological medicinal products

Guideline on similar biologicalmedicinalproductscontainingmonoclonal antibodies – non-clinical and clinicalissues ema/chmp/bmwp/403543/2010 page 6/16.

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Intrapartum fetal surveillance - queensland health

Queensland maternity and neonatal clinical guideline: intrapartum fetal surveillance document titl.

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Draft guideline on regulatory acceptance of 3rs

Guideline on regulatory acceptance of 3r (replacement, reduction, refinement) testing approaches ema/chmp/cvmp/jeg-3rs/450091/2012 page 6/10.

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Guideline o the investigation of bioequivalence

4/27 executive summary this guideline specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms.

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Committee for medicinal products for human use (chmp)

3/29 33 executive summary 34 this guideline defines when bioequivalence studies are necessary and formulates requirements for 35 their design, conduct, and evaluation..

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Guidance for industry - u s food and drug administration

Guidance for industry s1c(r2) dose selection for carcinogenicity studies u.s. department of health and human services food and drug administration.

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Summary for E 6 R1 Guideline For Good Clinical Practice