Results 71 to 80 of about 47,170 (292)

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

, 2011
With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and
Hentschel, Norbert, Zimmermann, Hartmut F   +1 more
core   +1 more source

Non‐contrast CT Markers of Hematoma Expansion and Andexanet Response in Factor Xa Inhibitor‐Associated Intracerebral Hemorrhage: An Analysis from ANNEXa‐I Trial

Annals of Neurology, EarlyView.
In this post hoc analysis of the ANNEXa‐I trial (n = 434), we evaluated non‐contrast computed tomography (NCCT) markers of hematoma expansion (HE) in factor Xa inhibitor (FXai) –associated intracerebral hemorrhage (ICH). At least one NCCT marker was present in 72.1%, and HE (≥12.5 mL or ≥ 35% increase in hematoma volume) occurred in 31.8 ...
Koji Tanaka, Umberto Pensato, Mohamed Alshamrani, Aristeidis H. Katsanos, Pargol Balali, Sucharita Ray, Scott E. Kasner, Jan Beyer‐Westendorf, Danilo Toni, David J. Seiffge, Carlos Molina, David Tanne, Anna Członkowska, Arne G. Lindgren, Daniel Bereczki, Else C. Sandset, Georgios Tsivgoulis, Hanne Christensen, Jonathan M. Coutinho, Peter Verhamme, Pierre Amarenco, Robin Lemmens, Roland Veltkamp, Saskia Middeldorp, Thompson Robinson, Truman J. Milling, Wilfried Lang, Vitor Tedium‐Cruz, Mark Crowther, Lizhen Xu, Mikael Knutsson, Per Ladenvall, John W. Eikelboom, Mukul Sharma, Ashkan Shoamanesh, Andrew M. Demchuk   +35 more
wiley   +1 more source

Development, qualification, and application of a highly efficient and robust new peak detection workflow for the LC-MS peptide mapping multi-attribute method

mAbs
The multi-attribute method (MAM) by liquid chromatography-mass spectrometry peptide mapping has the potential to replace multiple conventional HPLC- and capillary electrophoresis-based purity/impurity assays for release and stability testing of protein ...
Thomas Pohl, Patrick Sascha Merkle, Sonja Hudelmaier, Victor Le-Minh, Dominik Mertens, Claudio Schmid, Reto Ossola, Carsten Soenksen, Marlis Zeiler, Andrei Starikov, Edward Waterman, Petra Gutenbrunner, Nick DeGraan-Weber, Michelle English, François Griaud   +14 more
doaj   +1 more source

Advancing recombinant protein production in CHO cells through metabolic engineering

Frontiers in Bioengineering and Biotechnology
Chinese hamster ovary (CHO) cells serve as the predominant platform for producing recombinant therapeutic proteins in biopharmaceutical manufacturing, the production capacity of which relies heavily on efficient protein synthesis, folding, and secretion ...
Lu Hou, Lu Hou, Weidong Li, Weidong Li, Ziyan Li, Ziyan Li, Shaolei Geng, Shaolei Geng, Tianyun Wang, Tianyun Wang, Junhe Zhang, Junhe Zhang, Junhe Zhang   +12 more
doaj   +1 more source

Editorial: Separation Processes in Pharmaceutical Manufacturing

Frontiers in Chemical Engineering, 2022
Cristina Chuck-Hernández, Jia Wei Chew, Karla Mayolo-Deloisa, Bodhisattwa Chaudhuri, Bodhisattwa Chaudhuri   +4 more
doaj   +1 more source

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

British Journal of Clinical Pharmacology, EarlyView.
Abstract This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders.
Justin L. Hay, Amandine Manon, Hunter Stephens, S. Y. Amy Cheung, Bart de Keizer, Erik T. te Beek   +5 more
wiley   +1 more source

Apigenin Accumulation in Matricaria chamomilla and Petroselinum crispum Produced in a Vertical Hydroponic System

HortScience
Apigenin, an anticancer secondary metabolite, is produced in selected organs of a few plant taxa, including chamomile (Matricaria chamomilla) flowers and parsley (Petroselinum crispum) leaves. In this study, two cultivars of chamomile (Bodegold and Zloty
Rebekah C.I. Maynard, Samuel O. Ogundipe, Rhuanito Soranz Ferrarezi, Joon Hyuk Suh, Leonardo Lombardini   +4 more
doaj   +1 more source

Innovation Policy-making and Activities in the Biopharmaceutical Industry ?Case of the Developed Countries and Taiwan

, 2009
[[abstract]]The biopharmaceutical industry is an innovative sector of industry and is considered to have high potential for creating added value and hi-tech competitiveness.
Yang Hsiu-Chi
core  

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

A Master's program in biopharmaceutical science

, 1996
Australasian Biotechnology, Volume 6 Number 5, September/October 1996, pp.272-276 A Master's program in biopharmaceutical science by I.R. Neering, S.M. Mahler and M.W. Fryer Code Number: AU96010 Size of Files: Text: 18.6K Graphics: No associated graphics

core   +2 more sources