全部文献期刊学位论文会议报纸专利标准年鉴图书|学者科研项目
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作者:Andre Hermans , Andreas M. Abend ...
来源:[J].The AAPS Journal(IF 4.386), 2017, Vol.19 (6), pp.1537-1549Springer
摘要:This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS...
作者:Andre Hermans , Colleen M. Neu ...
来源:[J].The AAPS Journal(IF 4.386), 2019, Vol.21 (3), pp.1-20Springer
摘要:Abstract(#br)This manuscript represents the perspective of the Dissolution Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) and of two focus groups of the American Association of Pharmaceutical Scientists (AAPS): Process ...
作者:Andre Hermans , Filippos Kesisoglou ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2019, Vol.108 (9), pp.3054-3062Elsevier
摘要:Abstract(#br)In this article, experiments on tablets containing a model compound, grazoprevir, were conducted to explore how media selection for a quality control dissolution method can influence the sensitivity for the dissolution method toward drug crystallinity detection in an...
作者:Andre Hermans , Andreas Abend ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2018, Vol.107 (1), pp.34-41Elsevier
摘要:Abstract(#br)This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and bey...
作者:Andre Hermans , Rebecca Nofsinger ...
来源:[J].International Journal of Pharmaceutics(IF 3.458), 2018Elsevier
摘要:Abstract(#br)Drug development is a long process which requires careful evaluation of the drug substance (active pharmaceutical ingredient, API), drug product (tablet, capsule etc.) and the bioperformance (both pre-clinical and clinical) before testing the efficacy of the final do...
作者:Andre Hermans , Jason D. Ehrick ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2018Elsevier
摘要:Abstract(#br)Solubility, dissolution, and precipitation in the gastrointestinal tract can be critical for the oral bioavailability of weakly basic drugs. To understand the dissolution/precipitation during the transfer out of the stomach into the intestine, a multicompartment tran...
作者:... Kristel Dewitt , Andre Hermans , Aaron Cote
来源:[J].International Journal of Pharmaceutics(IF 3.458), 2019, Vol.559, pp.147-155Elsevier
摘要:Abstract(#br)Amorphous solid dispersions are a promising option for managing compounds with poor aqueous solubility. However, for compounds with high melting points, thermal stability limitations, or poor solubility in volatile solvents, conventional routes of hot melt extrusion ...
作者:Andre Hermans , Colleen Neu ...
来源:[J].Journal of Pharmaceutical Sciences(IF 3.13), 2015, Vol.104 (9), pp.2913-2922Elsevier
摘要:ABSTRACT:(#br)Although in vitro – in vivo correlations (IVIVCs) are commonly pursued for modified-release products, there are limited reports of successful IVIVCs for immediate–release (IR) formulations. This manuscript details the development of a Multiple Level C IVIVC for...

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