Considerations for Permitted Daily Exposure Calculation for Contaminants in Medicinal Products Manufactured in Shared Facilities

Considerations for Permitted Daily Exposure Calculation for Contaminants in Medicinal Products Manufactured in Shared Facilities

The manufacture of different medicinal products in shared facilities creates a risk of cross-contamination. One of the approaches to select the limits for possible contaminants is based on calculating the permitted daily exposure (PDE), i.e. the dose of an active pharmaceutical ingredient or any oth...

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Bibliographic Details
Main Authors: A. G. Solodovnikov, E. I. Morkovin, D. V. Kurkin, E. Yu. Sorokina, T. F. Peretolchina
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2022-10-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
permitted daily exposure
pde
contamination
interspecies dose extrapolation
the safety of the use of medicines
risk control
Online Access:https://www.vedomostincesmp.ru/jour/article/view/399
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