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A Simple Eco-Friendly HPLC-PDA Method for the Simultaneous Determination of Paclitaxel and Seliciclib in Plasma Samples for Assessing Their Pharmacodynamics and Pharmacokinetics in Combination Therapy for Uterine Sarcoma.
Medicina (Kaunas)
September 2024
Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
: Uterine sarcoma, a rare cancer originating in the smooth muscle of the uterus, exhibits high rates of recurrence and metastasis. It represents one of the most challenging types of cancer due to its chemorefractory nature, showing little response to conventional chemotherapy methods and displaying a relative survival rate of 30-40%. A potentially promising approach for treating uterine sarcoma involves combination therapy with paclitaxel (PAC), a microtubule-targeting agent, and seliciclib (SEL), a cyclin-dependent kinase inhibitor.
View Article and Find Full Text PDFWorldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine.
PDA J Pharm Sci Technol
August 2024
Sanofi, Panama City, Panama.
Article Synopsis
- After initial marketing authorization of a pharmaceutical product, manufacturers must manage numerous chemistry, manufacturing, and control (CMC) post-approval changes (PACs), complicated by varying regulatory requirements across countries.
- The World Health Organization (WHO) advocates for a "reliance" approach among national regulatory authorities (NRAs), allowing them to trust evaluations from efficient authorities to speed up the review process for PACs.
- Sanofi, with support from organizations like Health Canada and WHO, has launched a pilot program involving 21 NRAs to implement these reliance principles, aiming to shorten approval timelines for a vaccine's CMC PACs to six months after initial approval.
Agreement between cardiac output estimation with a wireless, wearable pulse decomposition analysis device and continuous thermodilution in post cardiac surgery intensive care unit patients.
J Clin Monit Comput
February 2024
Department of Surgery, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.
Purpose: Pulse Decomposition Analysis (PDA) uses integration of the systolic area of a distally transmitted aortic pulse as well as arterial stiffness estimates to compute cardiac output. We sought to assess agreement of cardiac output (CO) estimation between continuous pulmonary artery catheter (PAC) guided thermodilution (CO-CCO) and a wireless, wearable noninvasive device, (Vitalstream, Caretaker Medical, Charlottesville, VA), that utilizes the Pulse Decomposition Analysis (CO-PDA) method in postoperative cardiac surgery patients in the intensive care unit.
Methods: CO-CCO measurements were compared with post processed CO-PDA measurements in prospectively enrolled adult cardiac surgical intensive care unit patients.
A high-fibre personalised dietary advice given via a web tool reduces constipation complaints in adults.
J Nutr Sci
May 2022
Wageningen Food and Biobased Research, Wageningen University & Research, Bornse Weilanden 9, 6708 PD Wageningen, The Netherlands.
Constipation can greatly impact the quality of life (QoL), which can be relieved by dietary fibres; however, preserving a higher fibre intake remains a challenge. We investigated the effects of a personalised dietary advice (PDA) on fibre intake and mild constipation complaints. A total number of twenty-five adults with mild constipation complaints were included in a 4-week observation period followed by a 4-week personalised intervention.
View Article and Find Full Text PDFThe impact of a national COVID-19 lockdown on acute coronary syndrome hospitalisations in New Zealand (ANZACS-QI 55).
Lancet Reg Health West Pac
December 2020
Greenlane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
Background: Countries with a high incidence of coronavirus 2019 (COVID-19) reported reduced hospitalisations for acute coronary syndromes (ACS) during the pandemic. This study describes the impact of a nationwide lockdown on ACS hospitalisations in New Zealand (NZ), a country with a low incidence of COVID-19.
Methods: All patients admitted to a NZ Hospital with ACS who underwent coronary angiography in the All NZ ACS Quality Improvement registry during the lockdown (23 March - 26 April 2020) were compared with equivalent weeks in 2015-2019.
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