Safety Based Limits for the Control of Impurities in Drug Substances and Drug Products: A Review

Elder Dp
Additional contact information
Elder Dp: David P Elder Consultancy, Hertford, United Kingdom

Global Journal of Pharmacy & Pharmaceutical Sciences, 2017, vol. 1, issue 4, 109-116

Abstract: Safety based impurity limits are key to the effective reduction and control of impurities in medicinal products. Impurity limits now have a greater focus on daily exposure limits, with the introduction of various approaches, such as permitted daily exposure (PDEs), acceptable intake (AIs), threshold of toxicological control (TTCs) and staged TTCs all aimed at defining a virtually safe dose (VSD). This in turn led to the introduction of less than lifetime (LTL) limits for mutagenic impurities, which is based on an application of Haber’s law which states that concentration and exposure times are both critical for assessing likely safety risk to patients. Surprisingly, LTLs have not been applied to the other specific classes of impurities or indeed general impurities.

Keywords: juniper publishers:Journal of Pharmacy; Global Journal of Pharmacy; Pharmaceutical Sciences; Pharmacy & Pharmaceutical Sciences; pharmaceutical sciences journals; omics online; open access; drug discovery; Clinical Trials; juniper publishers open access journals; juniper publishers reivew (search for similar items in EconPapers)
Date: 2017
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
https://juniperpublishers.com/gjpps/pdf/GJPPS.MS.ID.555570.pdf (application/pdf)
https://juniperpublishers.com/gjpps/GJPPS.MS.ID.555570.php (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:adp:jgjpps:v:1:y:2017:i:4:p:109-116

DOI: 10.19080/GJPPS.2017.01.555570

Access Statistics for this article

Global Journal of Pharmacy & Pharmaceutical Sciences is currently edited by Sophia Mathis

More articles in Global Journal of Pharmacy & Pharmaceutical Sciences from Juniper Publishers Inc.
Bibliographic data for series maintained by Robert Thomas ().