| Autor: |
Sehner C; a Nonclinical Drug Safety , Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss , Germany., Schwind M; b HSE Germany, Sanofi-Aventis Deutschland GmbH , Frankfurt am Main , Germany., Tuschl G; c Global Chemical and Preclinical Safety , Merck KGaA , Darmstadt , Germany., Lovsin Barle E; d Department of Regulatory Affairs , Lonza AG , Basel , Switzerland. |
| Jazyk: |
angličtina |
| Zdroj: |
Pharmaceutical development and technology [Pharm Dev Technol] 2019 Sep; Vol. 24 (7), pp. 803-811. Date of Electronic Publication: 2019 May 06. |
| DOI: |
10.1080/10837450.2019.1592188 |
| Abstrakt: |
For the handling of active pharmaceutical ingredients (APIs) and production of medicinal products in shared facilities, the European Medicines Agency (EMA) has introduced the determination of permitted daily exposure (PDE) values to provide limits for cross-contamination. APIs have a desired pharmacological effect in the patient who intendedly uses a certain medicinal product. However, this effect is undesired in a patient that receives this API unintendedly as a cross-contamination of another medicinal product. In particular, for approved APIs for human use, a multitude of data is available on the pharmacological activity as well as adverse effects, which have to be taken into account in PDE setting. Thus, the setting of PDEs for APIs needs a structured scientific evaluation of all properties and identification of the most critical effect, which is the basis for PDE calculation. In this publication, we provide guidance on points for consideration when setting PDEs for APIs, or when evaluating the quality of documents describing the derivation of PDEs received, e.g. by third parties. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
|
|
Nepřihlášeným uživatelům se plný text nezobrazuje |
K zobrazení výsledku je třeba se přihlásit.
|
