Zobrazeno 1 - 10 of 28 pro vyhledávání: '"Pascal Chalus"'
1
Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper
Autor: Sonja Peter, Atanas Koulov, Andreas Zerr, Ombeline Danton, Hanns-Christian Mahler, Michael Jahn, Ariane Schröter, Pascal Chalus, Jörg Huwyler
Publikováno v: Journal of Pharmaceutical Sciences. 110:3410-3417
Leaching of toxic or reactive chemicals from polymeric materials can adversely affect the quality and safety of biopharmaceuticals. It was therefore the aim of the present study to analyze leachables from a disposable clinical administration syringe
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a5a0ca4568e05a7dedf4f47103a2a38
https://doi.org/10.1016/j.xphs.2021.05.017
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3
Evaluation of Different Quality-Relevant Aspects of Closed System Transfer Devices (CSTDs)
Autor: Pascal Chalus, Anja Matter-Schwald, Patrick Favrod, Pauline Heymes, Martin Vogt, Ahmed Besheer, Timothy Pillow, Sergio Mompart Barrenechea, Roman Mathaes, Susanne Joerg, Andrea Kirste, Hanns-Christian Mahler
Publikováno v: Pharmaceutical Research. 37
Health care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5313eeeb5347974f0d53053840d8bb1e
https://doi.org/10.1007/s11095-020-02784-1
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4
Characterization of Polymeric Syringes Used for Intravitreal Injection
Autor: Hanns-Christian Mahler, Dhananjay Jere, Atanas Koulov, Roman Mathaes, Ahmad S. Sediq, Susanne Joerg, Martin Vogt, Anja Matter, Sarah S. Peláez, Maximilian Zaeh, Pascal Chalus
Publikováno v: Journal of pharmaceutical sciences. 109(9)
Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye. Drug Products (DP) intended for IVT injections usually pose challenges such as a very low injection volume (e.g. 50 μL) and high injection force
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1efa64ca68e799a550fa4fee0d7b7992
https://pubmed.ncbi.nlm.nih.gov/32534032
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5
Mechanistic approach in powder blending PAT: Bi-layer mixing and asymptotic end point prediction
Autor: Pascal Chalus, Avinash Murthy, Lene Maurer, Siegfried Krimmer, Juraj Sibik
Publikováno v: Powder Technology. 308:306-317
We derive a simple first order kinetics model for the powder mixing in a bin blender and adapt it to fit the NIR spectra obtained during the real-time mixing. The model is tested on a full drug product formulation mixing consisting of API and multipl
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::577973691f28b14949eafa56841350ff
https://doi.org/10.1016/j.powtec.2016.12.038
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6
Method to Predict Glass Vial Fogging in Lyophilized Drug Products
Autor: Atanas Koulov, Pascal Chalus, Cristina Grigore, Hanns-Christian Mahler, Anja Matter, Carolin Langer, Susanne Joerg, Thomas Lemazurier, Nicolas Marti, Roman Mathaes, Satish K. Singh
Publikováno v: Journal of pharmaceutical sciences. 109(1)
Glass fogging is a phenomenon occurring in lyophilized drug products and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b22fadc6a860892d97d9495c7378ce8e
https://pubmed.ncbi.nlm.nih.gov/31473212
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7
Quantitative X-Ray Microcomputed Tomography Assessment of Internal Tablet Defects
Autor: Ajit S. Narang, Stefanie Peter, Shawn Zhang, Edward Yost, Pascal Chalus
Publikováno v: Journal of pharmaceutical sciences. 108(5)
Physical tablet defects are related to internal structural defects that are not easily assessed by the traditional methods, such as dusting, laminating, or fracturing during appearance, friability, or hardness testing. Also, these methods do not allo
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c8d235c027ffbb5459f07f78a597249f
https://pubmed.ncbi.nlm.nih.gov/30639743
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8
Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Autor: Alejandra Nieto, Hanns-Christian Mahler, Michael Adler, Holger Roehl, Pascal Chalus, Helen Brown
Publikováno v: PDA journal of pharmaceutical science and technology. 70(4)
Container closure integrity (CCI) testing is required by different regulatory authorities in order to provide assurance of tightness of the container closure system against possible contamination, for example, by microorganisms. Microbial ingress CCI
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::61e49ec226ee6747982dfb3774a874a9
https://pubmed.ncbi.nlm.nih.gov/27020649
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10
Combined wavelet transform–artificial neural network use in tablet active content determination by near-infrared spectroscopy
Autor: Serge Walter, Michel Ulmschneider, Pascal Chalus
Publikováno v: Analytica Chimica Acta. 591:219-224
The pharmaceutical industry faces increasing regulatory pressure to optimize quality control. Content uniformity is a basic release test for solid dosage forms. To accelerate test throughput and comply with the Food and Drug Administration's process
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1c67efef1209b2c70e44948e186d5f38
https://doi.org/10.1016/j.aca.2007.03.076
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