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Estimating the variability in fraction absorbed as a paradigm for informing formulation development in early clinical drug development.

Publication Type: Academic Journal

Source(s): European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2016 Jun 30; Vol. 89, pp. 50-60. Date of Electronic Publication: 2016 Apr 09.

Abstract: Purpose: Inter-subject variability in oral drug absorption is usually reported using bioavailability, which has the components: fraction absorbed (fa), fraction passing the gut wall (fg) and fraction escaping hepatic metabolism (fh). In this study, we ...

Ecotoxicogenomics: Microarray interlaboratory comparability.

Publication Type: Academic Journal

Source(s): Chemosphere [Chemosphere] 2016 Feb; Vol. 144, pp. 193-200. Date of Electronic Publication: 2015 Sep 10.

Abstract: Transcriptomic analysis can complement traditional ecotoxicology data by providing mechanistic insight, and by identifying sub-lethal organismal responses and contaminant classes underlying observed toxicity. Before transcriptomic information can be us...

Evaluation of critical process parameters for inter-tablet coating uniformity of active-coated GITS using Terahertz Pulsed Imaging.

Publication Type: Academic Journal

Source(s): European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2014 Oct; Vol. 88 (2), pp. 434-42. Date of Electronic Publication: 2014 Jul 15.

Abstract: The aim of this study was the evaluation of critical process parameters (CPP) for inter-tablet coating uniformity in an active pan coating process using nondestructive Terahertz Pulsed Imaging (TPI). Coating uniformity was assessed by calculating the c...

Robust method optimization strategy-a useful tool for method transfer: the case of SFC.

Publication Type: Academic Journal

Source(s): Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2014 Jan; Vol. 88, pp. 519-24. Date of Electronic Publication: 2013 Oct 12.

Abstract: The concept of Quality by Design (QbD) is now well established in pharmaceutical industry and should be applied to the development of any analytical methods. In this context, the key concept of Design Space (DS) was introduced in the field of analytica...

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