China
Africa
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A new geography of pharmaceuticals
Published in Carine Baxerres, Maurice Cassier, Understanding Drugs Markets, 2021
The agreement signed in May 2001 between WHO and Novartis aimed to complete the clinical data on the use of Coartem® and to set the price, which must not be at a profit when the drug is distributed in the public sector, and to establish the market. The agreement initially called for a Phase 4 clinical trial in three African countries to fill out data on Coartem® adherence, efficacy, and safety. The two partners agreed on co-ownership of the data from this trial, which was financed on a shared basis. WHO, via TDR, would also collaborate with Novartis to improve the drug packaging to increase patient compliance. This collaborative development work (Article 2: Collaborative development work)29 helps justify Coartem®'s preferential price for the public sector, as public funds have been used for R&D.
Non-Vaccine VLPs
Published in Paul Pumpens, Single-Stranded RNA Phages, 2020
Numerous reviews concentrated at that time on the general problems of the VLP cages as the most attractive nanocarrier platforms for drug packaging and targeted delivery, always with special emphasis on the MS2 and Qβ VLPs, mentioning, less often, also the PP7, AP205, and φCB5 VLPs (Ma Y et al. 2012; Doll et al. 2013; Steinmetz 2013; Wu Y et al. 2013; Deshayes and Gref 2014; Galdiero et al. 2014; Hong and Nam 2014; Jin et al. 2014; Molino and Wang 2014; Schoonen and van Hest 2014; Shi et al. 2014; Vannucci et al. 2014; Bajaj and Banerjee 2015; Ferrer-Miralles et al. 2015; Putri et al. 2015; Schwarz and Douglas 2015; Varshosaz and Farzan 2015; Yan et al. 2015; Aljabali 2016, 2018; Luo et al. 2016; Zdanowicz and Chroboczek 2016; Bhaskar and Lim 2017; Czapar and Steinmetz 2017; Gardiner Heddle et al. 2017; Karimi et al. 2017; Meghani et al. 2017; Parodi et al. 2017; Rohovie et al. 2017; Roudi et al. 2017; Sunderland et al. 2017; Tashima 2017; Aljabali et al. 2018; Alshaer et al. 2018; Aumiller et al. 2018; Choi B et al. 2018; Diaz et al. 2018; Hill et al. 2018; Kawano et al. 2018; Kelemen et al. 2018; Lam and Steinmetz 2018; Lemire et al. 2018; Ngandeu Neubi et al. 2018; Casanova et al. 2019; Jeevanandam et al. 2019; Li B et al. 2019; Pottash et al. 2019; Sokullu et al. 2019).
Ethics Analysis of Imaging Scenarios
Published in Jim Malone, Friedo Zölzer, Gaston Meskens, Christina Skourou, Ethics for Radiation Protection in Medicine, 2018
Jim Malone, Friedo Zölzer, Gaston Meskens, Christina Skourou
After some deliberation, the authorities decide that she may be a drug mule. The customs officer in charge is also concerned about the serious consequences of a puncture in the drug packaging in the intestines of the young woman. Hence an abdominal/pelvic CT scan is requested from a local hospital with which the customs service has a contract to provide scans in such circumstances. The suspect appears otherwise healthy. She is not appraised of the radiation exposure or any other risks associated with the scan and permission is not sought. She strenuously objects to the procedure but is advised that she will be held until it is performed. Eventually, she consents so that she can go home, as she knows she is innocent. The scan is then performed promptly, competently and with optimised settings.
The implementation of risk minimization measures to prevent teratogenic pregnancy outcomes related to oral retinoid and valproate use in Belgium
Published in Acta Clinica Belgica, 2022
Xander Bertels, Els Mehuys, Koen Boussery, Lies Lahousse
Fisher’s Exact test was used to compare proportions of a nominal variable between groups. Multiple logistic regression was used to investigate the relationship between compliance with the key aspects of the PPP and potential determinants (population characteristics and RMM usage). For patients, age, education and exposure to RMMs were investigated. The RMMs included receiving the a) patient reminder card, b) information brochure, c) risk acknowledgement form (RAF) or checklist or d) signing the RAF or checklist, e) reading the patient information leaflet, f) noting the boxed warning on drug packaging, g) discussing contraception with a HCP. Education was recoded into a dichotomous variable (college/university/PhD vs lower). For HCP, age, sex, speciality, experience and the use of educational materials were studied. A significance level of 0.05 was used and two-sided p-values were reported. All statistical analyses were conducted in IBM SPSS Statistics for Windows, Version 27.0 (IBM Corp., Armonk, NY).
A Multidisciplinary Evaluation of Barriers to Enrolling Cancer Patients into Early Phase Clinical Trials: Challenges and Patient-centric Recommendations
Published in Expert Opinion on Investigational Drugs, 2019
Hani M Babiker, Lisa Davis, Kristian Larson, Crystal Placencia, Connor Swensen, Pavan Tenneti, Melissa Lim, Ruth Cañamar, Jacqueline Curtis, Erica Castillo, James Mancuso, Diane Rensvold, Sarah Martinez, Lora Macias, Alejandro Recio-Boiles, Sreenivasa R Chandana, Daruka Mahadevan
Several potential risks for medication errors are unique to IPs as compared to commercially available drugs, and these concerns are particularly evident for early formulations most common in early phase trials. These include, but are not limited to, differences in product names and characteristics, packaging, and expiration dating [17]. Further, institutions involved in more than one trial involving the same IP need to pay close attention to avoid mixing up clinical trial drug supplies. Computerized prescriber order entry (CPOE) with clinical decision support systems (CDSSs) are recommended to reduce medication-related errors associated with IPs [15]. However, due to the nature of products early in development, drug-allergy, drug-laboratory value, and drug–drug interaction checks are frequently unavailable in these computerized systems. Clinicians must rely on information from the investigator’s brochure (IB) and their clinical knowledge and judgment to avoid potentially harmful interactions. Investigational drug packaging and labeling features that promote distinguishing characteristics, among other products, and within the product line of different formulations or for different trials should be encouraged and developed when possible [17].
‘Adequacy between medical prescription and intake of analgesics for acute low back and neck pain after presentation at the emergency department – do we prescribe too many tablets?’
Published in Acta Clinica Belgica, 2022
emilie Delloye, Vanessa Wauters, Jean-Bosco Masabarakiza, Florence Dupriez
This study brings to light the fact that, in our country, and for acute muscular low back and neck pain, patients seem to be prescribed too many tablets of analgesics for their actual needs. As discussed above, these remaining tablets might represent a problem in many ways. Other studies are needed to evaluate the real socio-economic and environmental impact of drug surplus in the box prescription system. These studies should also address the impact of remaining tablets on drug misuse. This could encourage making changes to prescription habits in many countries currently using the prescription of standardized drug packaging. Efforts should be made in the medical and pharmaceutical fields to reduce waste globally.