Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE).

Autor: Wiesner L; a Novartis Pharma AG, Postfach , Basel , Switzerland., Prause M; a Novartis Pharma AG, Postfach , Basel , Switzerland., Lovsin Barle E; a Novartis Pharma AG, Postfach , Basel , Switzerland.
Jazyk: angličtina
Zdroj: Pharmaceutical development and technology [Pharm Dev Technol] 2018 Mar; Vol. 23 (3), pp. 261-264. Date of Electronic Publication: 2017 Jun 07.
DOI: 10.1080/10837450.2017.1334665
Abstrakt: Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.
Databáze: MEDLINE
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