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… Identifying a Drug's Safety Profile Antiepileptic drugs in pregnancy, and … Health Solutions, has explored the association between the use of antiepileptic drugs in pregnancy and pregnancy … length, and head circumference. We conducted a cohort study using nationwide Swedish Registry data. The study …
… Medicare Drug Price Negotiation: Opportunities for Manufacturers in … Collection Request (ICR) form, which manufacturers use to submit data to CMS in support of their products. … head-to-head randomized controlled trials, pragmatic clinical trials, network meta-analyses, observational …
… Values for Carers and Family Members in HTAs: a Case Study of Recent NICE Appraisals in the UK Basarir H, …
… diseases. But the available evidence to support orphan drug reimbursement is often of lower quality due to smaller patient populations available for clinical studies. Several European countries have introduced … To ensure equitable decision-making, manufacturers should use a range of evidence sources and techniques, including …
… Identifying an Appropriate Drug for Comparative Safety Research Antiepileptic Drugs in … Around 0.5% of women in Europe and 2% of women in the US use antiepileptic drugs during pregnancy. It is important to … for preterm delivery. The orange dots represent the study results; the black horizontal bars represent the 95% …
… data sources Decision-analytic models Disease prevalence Drug utilization studies Economic analyses of clinical trial designs and validations studies of clinical … burden of illness studies Epidemiology reports for orphan drug applications and pediatric investigational plans …
… patient committee participants on the FDA-sponsored study to adapt an in-clinic outcome assessment tool for ALS to remote-use at home. Panel 3: Patient Engagement at FDA March 1, … of certain groups of otherwise eligible subjects in clinical trials. This panel also includes discussion of …
… Diversity, Inclusion, and Belonging in Patient Centered Drug Development Chad Downey, BS Associate Director, Project … EDIB principles to the collection, interpretation, and use of patient preference information can support more inclusive and equitable health outcomes. Our case study identifies three ways to apply principles of EDIB to …
… Drug Safety in Pregnancy Satisfy Regulatory Requirements With … the safety of your product if pregnant persons might use it. Typical requests from regulatory agencies include … in perinatal pharmacoepidemiology and have reviewed study approaches typically required by regulatory …
… Cost-Effective Second-Line ADHD Drug with Better Efficacy Reported Share on: August 25, 2016 … dimesylate (LDX) or atomoxetine. A recent study by two RTI-HS researchers published in CNS Drugs found … currently recommended first-line stimulant treatment. The study, titled A Cost-Utility Analysis of Lisdexamfetamine …