Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Feb 2019
Generic Drugs in the United States: Policies to Address Pricing and Competition.
The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter the market, but the past decade has witnessed rising costs and shortages of generic drugs. ⋯ We discuss the FDA's role in addressing drug prices and promoting competition, including recent agency policies to modify its process of reviewing generic drug applications and to prioritize applications for off-patent drugs with few competitors. We also examine proposed policy solutions and research areas that could help address the price increases of off-patent drugs.
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Clin. Pharmacol. Ther. · Jan 2019
A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers.
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown. ⋯ Recently, development strategies resulting in longer approval lag were used by pharmaceutical companies more often for the development of drugs used to treat minor cancers than for drugs targeting major cancers, leading to significant differences in the approval lag time between drugs for major and minor cancers. Effective measures that expedite the development of drugs targeting minor cancers in Japan should, therefore, be implemented to shorten lag time.
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Clin. Pharmacol. Ther. · Jan 2019
Observational StudySerious Hypoglycemia and Use of Warfarin in Combination With Sulfonylureas or Metformin.
Prior research suggests that warfarin, when given concomitantly with some sulfonylureas, may increase the risk of serious hypoglycemia. However, the clinical significance remains unclear. ⋯ Particularly in the late risk window (>120 days since beginning concomitancy), most of the RRs for warfarin were elevated: glipizide (RR, 1.72; 95% CI, 1.29-2.29), glyburide (RR, 1.57; 95% CI, 1.15-2.15), metformin (RR, 2.26; 95% CI, 1.67-3.05), and glimepiride (RR, 1.56; 95% CI, 0.97-2.50). These results are consistent with a previously hypothesized hypoglycemic effect of warfarin in patients with type 2 diabetes through inhibition of the carboxylation of osteocalcin.
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Mainstream broadcasting media is a potentially powerful avenue for disseminating wellness education. For example, it can be used for community-based risk management, including preparing for pandemic events. The media can have a considerable positive impact on the public by increasing their health knowledge, changing attitudes and intentions, and influencing health behavior. However, although the broadcasting media can usefully convey prosocial, healthy messages, there is also a risk of propagating incorrect and antisocial, poor public health information.
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Clin. Pharmacol. Ther. · Aug 2018
Pharmacokinetics, Pharmacodynamics, and Proposed Dosing of the Oral JAK1 and JAK2 Inhibitor Baricitinib in Pediatric and Young Adult CANDLE and SAVI Patients.
Population pharmacokinetic (popPK) modeling was used to characterize the PK profile of the oral Janus kinase (JAK)1/JAK2 inhibitor, baricitinib, in 18 patients with Mendelian interferonopathies who are enrolled in a compassionate use program. Patients received doses between 0.1 to 17 mg per day. Covariates of weight and renal function significantly influenced volume-of-distribution and clearance, respectively. ⋯ On therapeutic doses, the mean area-under-the-concentration-vs.-time curve was 2,388 nM*hr, which is 1.83-fold higher than mean baricitinib exposures in adult patients with rheumatoid arthritis receiving doses of 4 mg once-daily. Dose-dependent decreases in interferon (IFN) biomarkers confirmed an in vivo effect of baricitinib on type-1 IFN signaling. PopPK and pharmacodynamic data support a proposal for a weight- and estimated glomerular filtration rate-based dosing regimen in guiding baricitinib dosing in patients with rare interferonopathies.