CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).
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http://dx.doi.org/10.5731/pdajpst.2011.00828 | DOI Listing |
Eur Heart J Case Rep
December 2024
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, William Henry Duncan Building, 6 W Derby St, Liverpool L7 8TX, UK.
Background: Epicardial ventricular tachycardia (VT) ablation is an established approach in patients with epicardial arrhythmogenic foci and is most commonly performed via percutaneous access. An alternative approach is via video-assisted thoracoscopic surgery (VATS), although reports of this technique are limited to the use of catheter-based technologies for radiofrequency ablation delivery.
Case Summary: A 55-year-old man with non-ischaemic cardiomyopathy presented with recurrent VT despite medical therapy.
Mol Pharm
November 2024
Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM case studies from six regulatory authorities which provided considerations for model verification, validation, and application based on the context of use (COU) of the model. PBBM case studies to define critical material attribute (CMA) specification settings, such as active pharmaceutical ingredient (API) particle size distributions (PSDs) were shared.
View Article and Find Full Text PDFObjective: Racial and ethnic minority groups are underrepresented in chiropractic education and the profession, and are less likely than individuals identifying as White to have access to or use chiropractic care. Stakeholders with leadership positions in USA-based chiropractic colleges and organizations participated in 3 online diversity, equity, and inclusion (DEI) summit meetings to foster a deeper understanding of DEI, identify DEI objectives, and develop action steps and drive change. Summit I (51 attendees) comprised 3 presentations that provided background about DEI in chiropractic education and practice.
View Article and Find Full Text PDFJ Rheumatol
October 2024
C. Lindsay, PharmD, GRAPPA Patient Research Partner, Dallas, Texas, USA.
Nine patient research partners (PRPs) attended the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting in person in Dublin, Ireland. The importance of close relations between researchers, clinicians, and PRPs was highlighted at the PRP premeeting, with discussion regarding PRP engagement within GRAPPA with the GRAPPA leadership team. A presentation was given by PRPs at the plenary session, and there was continued active engagement of PRPs in breakout sessions, workshops, and plenary sessions compared to previous annual meetings.
View Article and Find Full Text PDFMol Pharm
August 2024
Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented their views on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification.
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