The United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. The publication status of these trials in the medical literature and factors associated with publication have not been evaluated. We sought to determine the proportion of trials submitted to the FDA in support of newly approved drugs that are published in biomedical journals that a typical clinician, consumer, or policy maker living in the US would reasonably search.
It is postulated that pharmacological targeting of putative stromal support functions, in particular those of cancer-associated fibroblasts, could have therapeutic utility, and sought to assess the possibility in a pre-clinical setting.
The clinical trial data presented provides evidence of the ability of MVA85A to boost BCG primed immune responses. The findings have important implications for the design of efficacy trials with MVA85A.
RCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug.
In addition to individual-level protection (i.e., vaccine efficacy), the population-level implications of pre-pandemic vaccine programs should be considered when deciding on stockpile size and dose.
The aim of this study was to investigate the use of thermotropic liquid crystalline (TLC) blends of 4-pentyl-4′-cyanobiphenyl (K15) and 4-heptyl-4′-cyanobiphenyl (K21) with appropriate nematic to isotropic phase temperature (Tn − i) just above body temperature as a temperature-modulated drug permeation system.
-A Cohort Study in the Philippines
Treatment of patients with MDR-TB using the DOTS-Plus strategy and individualised drug regimens can be feasible, comparatively effective, and cost-effective in low- and middle-income countries. The study was partly supported by grants provided to the World Health Organization by the United States Agency for International Development and the Bill and Melinda Gates Foundation, and a grant from the Special Programme for Training and Research in Tropical Diseases.
Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice.
-A Case Study with Croscarmellose Sodium
Na Zhao and L.L. Augsburger,Univeristy of Maryland School of Pharmacy, Baltimore, MD, USA
The purpose of this study is to investigate factors influencing croscarmellose sodium functionality with special emphasis on developing a discriminating model tablet formulation to evaluate product brand-to-brand variability. The particle size distribution, water uptake, and swelling properties of five brands of croscarmellose sodium in either neutral water or 0.1 N HCl were studied.
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