Peer-Reviewed Research

Jul 02, 2017
Pharmaceutical Technology
Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.
Jun 02, 2017
Pharmaceutical Technology
In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Apr 02, 2017
Pharmaceutical Technology
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Mar 02, 2017
Pharmaceutical Technology
This study investigated the stability of solid lactose stored under high temperature and humidity conditions.
Feb 02, 2017
Pharmaceutical Technology
This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
Jan 02, 2017
Pharmaceutical Technology
The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
Dec 02, 2016
Pharmaceutical Technology
The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.
Nov 02, 2016
Pharmaceutical Technology
This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.
Oct 02, 2016
Pharmaceutical Technology
This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.
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