QUOTATION CLOPIDOGREL 75 Tablets Study design: a two-period, crossover, single-dose bioequivalence study in 36 healthy volunteers of both sexes, clinical confinement during 10 hours before and 32 hours after the dose, 20 blood samples per subject per period will be collected before dosing and till 32 hours after the Ler mais…
Good Laboratory Practices (GLP) Training – The History & Purpose of GLP What is GLP? Test Facility Organisation & Personnel Management responsibilities Study Director responsibilities Principal Investigator responsibilities Study Personnel responsibilities Study plans, SOPs and the master schedule Inspections Final reports Reporting QA findings The QA statement Test facility Ler mais…
GMP certification Good manufacturing practices (GMP) são as práticas necessárias para estar em conformidade com as diretrizes recomendadas por agências que controlam a autorização e o licenciamento da fabricação e venda de alimentos e bebidas, Cosméticos,produtos farmacêuticos,suplementos alimentares,e dispositivos médicos. These guidelines provide minimum requirements that a manufacturer must meet Ler mais…