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Evaluating Current Practices in Shelf Life Estimation

The current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) methods for determining the supported shelf life of a drug product, described in ICH guidance documents Q1A and Q1E, are evaluated in this paper. To support this evaluation, an industry data set is used which is comprised of 26 individual stability batches of a ...

Arabidopsis protein disulfide isomerase-8 is a type I endoplasmic reticulum transmembrane protein with thiol-disulfide oxidase activity

Background In eukaryotes, classical protein disulfide isomerases (PDIs) facilitate the oxidative folding of nascent secretory proteins in the endoplasmic reticulum by catalyzing the formation, breakage, and rearrangement of disulfide bonds. Terrestrial plants encode six structurally distinct subfamilies of PDIs. The novel PDI-B subfamily is unique to terrestrial plants, and in ...

Estimates of five restricted partition functions that are quasi polynomials

denumerants and Lambert series . Am. J. Math. 65 , 382 - 386 ( 1943 ) 2. David Christopher , A. , et al.: Relatively prime uniform partitions . Gen. Math. Notes 13 ( 2 ), 1 - 12 ( 2012 ) 3. Nathanson , M.B

In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches

This article is part of a series of reports from the “Orlando Inhalation Conference-Approaches in International Regulation” which was held in March 2014, and coorganized by the University of Florida and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The goal of the conference was to foster the exchange of ideas and knowledge across the ...