Multi-year Study of PAHs in Mainstream Cigarette Smoke.

Objectives: Correlations are made between mainstream cigarette smoke deliveries of individual PAHs over multiple years. Average overall PAH deliveries in mainstream cigarette smoke by study year, mentholation, ring size, and manufacturer are compared.

Methods: Mainstream smoke deliveries were determined by GC/MS for 14 polycyclic aromatic hydrocarbons (PAHs) from selected cigarettes on the US market in 2002, 2004, 2007, and 2011.

Use of data mining at the Food and Drug Administration.

Objectives: This article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA).

Target Audience: We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities.

Scope: Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA.

The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group.

Bayesian applications in medical product development have recently gained popularity. Despite many advances in Bayesian methodology and computations, increase in application across the various areas of medical product development has been modest. The DIA Bayesian Scientific Working Group (BSWG), which includes representatives from industry, regulatory agencies, and academia, has adopted the vision to ensure Bayesian methods are well understood, accepted more broadly, and appropriately utilized to improve decision making and enhance patient outcomes.

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

Background: Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses.

Meta-analysis of a possible signal of increased mortality associated with cefepime use.

Background: On the basis of meta-analyses, concern has been raised regarding a possible signal of increased mortality associated with the use of cefepime versus other beta-lactam antibiotics. To further investigate this possible signal, we accessed findings and data from published and unpublished cefepime clinical trials.

Methods: We performed meta-analyses using trial- and patient-level data from comparative trials.

Changes in US antidepressant and antipsychotic prescription patterns during a period of FDA actions.

Purpose: To determine if paroxetine versus non-paroxetine selective serotonin reuptake inhibitors (SSRIs) prescribing changed after the June 2003 FDA Paroxetine Public Health Advisory (PPHA) and if antidepressant and antipsychotic prescribing changed after the February 2004 FDA Advisory Committee Meeting (FDACM).

Methods: Ecologic analysis using estimates of patients dispensed antidepressants and antipsychotics, census data, and promotional spending data. Data sources were SDI: Vector One(R), US Census, and IMS Health(R).

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

Background: The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America.

Purpose: SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period.

Methods: SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions.

Treatment of plague with gentamicin or doxycycline in a randomized clinical trial in Tanzania.

Background: Over the past 50 years, antibiotics of choice for treatment of plague, including streptomycin, chloramphenicol, and tetracycline, have mostly become outdated or unavailable. To test gentamicin in the treatment of naturally occurring plague and the implications of its use in the treatment of bioterrorist plague, a randomized, comparative, open-label, clinical trial comparing monotherapy with gentamicin or doxycycline was conducted in Tanzania.

Methods: Sixty-five adults and children with symptoms of bubonic, septicemic, or pneumonic plague of < or =3 days duration were enrolled in the study.