Discussed is the problem of sample size determination for one- and two-stage hypothesis tests comparing two binomial proportions using two independent random samples. A FORTRAN compiled search algorithm identifies exact group sequential designs that allow early stopping only for futility or only for efficacy or for either futility or efficacy. The resulting designs yield a substantial savings in terms of total sample size in many practical cases, are seen to satisfy a number of desirable properties, and are compared to other exact one- and two-stage designs and to designs derived based upon asymptotic normal theory methods.
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http://dx.doi.org/10.1080/10543400903280621 | DOI Listing |
Sci Rep
January 2025
Department of Intelligent Systems Engineering, Indiana University, Bloomington, IN, USA.
We develop an algorithm that finds the consensus among many different clustering solutions of a graph. We formulate the problem as a median set partitioning problem and propose a greedy optimization technique. Unlike other approaches that find median set partitions, our algorithm takes graph structure into account and finds a comparable quality solution much faster than the other approaches.
View Article and Find Full Text PDFNat Rev Dis Primers
January 2025
Division of Nephrology, Department of Medicine IV, Hospital of the Ludwig-Maximilians University, Munich, Germany.
Chronic kidney disease (CKD) is defined by persistent abnormalities of kidney function or structure that have consequences for the health. A progressive decline of excretory kidney function has effects on body homeostasis. CKD is tightly associated with accelerated cardiovascular disease and severe infections, and with premature death.
View Article and Find Full Text PDFJ Pharm Sci
January 2025
Amicus Therapeutics Inc., 47 Hullfish St., Princeton, NJ 08542.
N-nitrosamines are a class of compounds belonging to the "cohort of concern" and characterized by the linkage of a nitroso group (-N=O) to an amine functional group (-NR). Some of these compounds are mutagenic, genotoxic, and potentially carcinogenic agents in humans, which necessitates control at acceptable safe levels. The current work presents a comprehensive risk assessment and mitigation strategy for two complex diastereomeric nitrosamines as New Drug Substance Related Impurities (NDSRIs) for miglustat 65mg capsules.
View Article and Find Full Text PDFBackground: Radio-chemotherapy remains the mainstay of glioblastoma first-line treatment after extended surgery, but the prognosis is still poor. PARP inhibitors like olaparib may improve glioblastoma outcomes. We implemented a phase 1-2a trial to assess the safety and efficacy of olaparib combined with standard radio-chemotherapy as a first-line treatment in unresected glioblastoma patients.
View Article and Find Full Text PDFJ Pharm Policy Pract
January 2025
Department of Community Health and Behavioral Sciences, Makerere University School of Public Health, Kampala, Uganda.
Background: The medicines retail sector (MRS) enables access to life-saving health commodities. Despite efforts to harness this market for public health goals, in low- and middle-income countries it is rarely incorporated into pandemic preparedness. This paper analyses the role of the MRS in the response to COVID-19 in Uganda, the extent to which it was incorporated into national planning and in the continuity of essential services.
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