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Showing results for "drug".

301. S16 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/s16.pdf
     October 01, 2007 - The regulatory framework for the drug approval process ensures a relatively predictable body of evidence … Neither these trials nor the drug approval process itself is designed to address all the needs of the … The evidence needed for drug approval addresses only the first of 3 questions that Archie Cochrane (the … Drug coverage—Which bisphosphonate drugs should be included on a drug fomulary? … Implications of pharmacogenomics for drug development and clinical practice.

302. #06 Developmental Delays ADHD, and Autism (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/developmental-delays-horizon-scan-high-impact-1312.pdf
     December 01, 2013 - Food and Drug Administration for inducing or augmenting labor and could be prescribed off label for … Food and Drug Administration (FDA). Oxytocin. [internet]. Silver Spring (MD): U.S. … Food and Drug Administration (FDA) [accessed 2013 Nov 18]. [2 p]. … Food and Drug Administration (FDA). Syntocinon. [internet]. Silver Spring (MD): U.S. … Food and Drug Administration (FDA) [accessed 2013 Nov 18]. [2 p].

303. Arthritis and Nontraumatic Joint Disease (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-1412.pdf
     December 01, 2014 - similar drugs in the same class are read separately), and then topics in the same class of a device, drug … payers similar to other uric acid–lowering drugs for treating or preventing gout, although if the drug … Patients would likely accept a new treatment option that could help them reduce their sUA if the drug … Some experts thought that as a new drug, lesinurad could be more expensive than existing options and … adding to disparities.14,15,17,18 However, some experts suspect third-party payers will cover the drug

304. Diabetes Mellitus (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/diabetes_hi_impact.pdf
     March 01, 2012 - Food and Drug Administration (FDA) treatment investigational new drug program to patients in the U.S … The company also reported the drug led to reduced body weight after 24 and 48 weeks of treatment. … Food and Drug Administration (FDA) guidelines set for CLS studies. … Food and Drug Administration (FDA); 2011 Feb 16 [accessed 2011 May 23]. [2 p]. … Drug pipeline. [internet].

305. Urinary-Incontinence-Treatment Surveillance (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/urinary-incontinence-treatment_surveillance.pdf
     October 29, 2012 - The Food and Drug Administration (FDA), Health Canada, and Medicines and Healthcare products Regulatory … would produce prima facie evidence that a conclusion was out of date, such as the withdrawal of a drug … Recently published RCTs examined different doses of the drug and demonstrated minimal additional or … The drug needed to be given to eight older patients to achieve more than a 50 percent reduction in … The drug needed to be given to eight older patients to achieve more than a 50 percent reduction in UI

306. PEPTIC ULCER #11 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/11_peptic_ulcer_potential_high_impact_2012-12-111.pdf
     January 01, 2012 - In 2000, teduglutide received orphan drug designation for treating SBS. … In August 2011, NPS began submitting data for a new drug application to FDA for the same indication …  Key Expert Comments: Experts commenting on this drug believe that these reductions in PN could … The drug is also expected to be widely accepted by patients. … Food and Drug Administration (FDA); 2009 Oct 2 [accessed 2011 Feb 14]. [2 p].

307. PEPTIC ULCER #11 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/11_pepticulcer_potential_high_impact_june_2012.pdf
     January 01, 2012 - In 2000, teduglutide received orphan drug designation for treating SBS. …  Key Expert Comments: Experts commenting on this drug believe that these reductions in PN could … Additional, less salient considerations included potential drug-drug interactions, the possibility … The drug is also expected to be widely accepted by patients. … Food and Drug Administration (FDA); 2009 Oct 2 [accessed 2011 Feb 14]. [2 p].

308. Data-Points-6-Tables1 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/data-points-6-tables1.pdf
     January 01, 2009 - 1 Number of Beneficiaries With at Least One Part A, B, or D Drug Claim for a Biologic of Interest, … Continuously Enrolled Medicare Parts A and B Fee-for-Service (FFS) Population, by Class of Drug and … Biologics of Interest Among Continuously Enrolled Medicare Parts A and B FFS Population, by Class of Drug … 79.12 77.58 73.12 6 Demographic Breakdown of Beneficiaries With at Least One Part A, B, or D Drug … for a Biologic of Interest, Continuously Enrolled Medicare Parts A and B FFS Population, by Class of Drug

309. Layout 1 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/cancer-anemia_executive.pdf
     May 01, 2006 - epoetin alfa (Epogen®, Procrit®) and darbepoetin alfa (Aranesp®), which is a newer and longer acting drug … A review of these various trials may help maximize benefit, optimize drug usage, and minimize adverse … however, evidence is insufficient to determine if risk is lower when treatment conforms to Food and Drug … d Rationales for comparing these alternative strategies are: (1) Drug concentrations with fixed-dose … More frequent dosing schedules are less convenient, but may be more effective to maintain the desired drug

310. Treatment of Hepatitis C Virus Infection in Adults: Future Research Needs (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/hepatitis-c-treatment-future_research.pdf
     April 01, 2013 - Appendix D: The name of drug TCM435 has been changed to simeprevir. 2. … users versus patients without IV drug use? … users versus patients without IV drug use?” … users vs. patients without IV drug use? … Antiviral therapy in HCV patients with IV drug use vs. those without IV drug use.

311. Introduction (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/rheumatoid-arthritis-medicine-1_research.pdf
     February 01, 2009 - used to identify adults with both a diagnosis of RA and at least one disease modifying anti-rheumatic drug … Register, other investigators reported that 18% of patients who initially met ACR criteria for RA were in drug-free … Trends in prescription drug expenditures by Medicaid enrollees. … A Blue Report on High Prescription Drug Use in Tennessee and its Consequences. Blue Series.

312. Disposition of Comments Report for CER 132 Combination Therapy Versus Intensification of Statin Monotherapy: An Update (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/high-cholestorol-medicines-update_disposition-comments.pdf
     September 01, 2014 - It is now understood that cIMT changes induced by drug therapies do not consistently reflect effects … Public reviewer #2AbbVie Introduction Table 1 shows the relative effect of different drug classes … If high drop-out rates due to the drug, efficacy will by necessity by more limited. … We have added this summary information regarding effect on LDL to the SOE tables for each drug. … pg 195, line 4—“Drug is not” what?

313. Urinary-Incontinence-Treatment Research-Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/urinary-incontinence-treatment_research-protocol.pdf
     September 30, 2010 - Drug therapy for stress urinary incontinence:18 Seratonin-noradrenaline uptake inhibitors: Duloxetine … - We will review the effects of different drug formulations (by doses and routes of administration … Eligible interventions of drug therapies or nonsurgical treatments. … The regulatory documents include medical and statistical reviews from the FDA, Health Canada - Drug … Food and Drug Administration, 5630 Fishers Lane, Room 1061.

314. Title (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/mental-illness-adults-prisons_research-protocol.pdf
     September 13, 2012 - National Survey on Drug Use and Health. … Drug therapy/ Exp antidepressive agents/ Psychotropic drugs/ Therapeutic use.fs. … EMBASE Drug therapy.fs. … Drug therapy Drug treatment/s Drug-based Incarceration-based drug treatment Mood stabiliser/s … therapy/ OR drug therapy.fs.

315. Systematic Review on Opioid Treatments for Chronic Pain: Surveillance Report 3 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/opioid-chronic-pain-surveillance-report-3.pdf
     June 01, 2022 - Drug Overdose/ 27. or/17-26 28. Substance Abuse Detection/ 29. … Drug Overdose/ 25. or/17-24 26. risk$.ti,ab,kf. 27. … Measures of diagnostic accuracy • Intermediate outcomes (e.g., pharmacokinetics/pharmacodynamics, drug-drug … Administration patient-level drug safety study data. … Predictive Modelling of Susceptibility to Substance Abuse, Mortality and Drug-Drug Interactions in

316. Data-Points-8 Tables1 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/data-points-8_tables1.pdf
     January 01, 2009 - Total Drug Cost and Out-of-Pocket Cost, by Antihypertensive Drug Class, Among Medicare Parts A, B, and … Total Drug Cost Total Out-of- Pocket Pay- ment Total Drug Cost Total Out-of- Pocket Pay … Total Drug Cost Total Out-of- Pocket Pay- ment Total Drug Cost Total Out-of- Pocket Pay … Total Drug Cost, by Antihypertensive Drug Class, Among Medicare Parts A, B, and D Beneficiaries With … Dartmouth Atlas of Health Care Maps of Total Drug Cost by Antihypertensive Drug Class Among Medicare

317. Evidence-based Practice Center Systematic Review Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/angina-heart-attack-treatments_research-protocol.pdf
     December 11, 2012 - metabolic conversion takes place via the hepatic cytochrome P-450 isoenzymes and is susceptible to drug … Adverse drug reactions (thrombocytopenia, allergic drug reaction) 2. … reactions (thrombocytopenia, allergic drug reaction), bleeding, and stent thrombosis None 14 … The safety outcomes will be framed to help identify adverse events, including adverse drug reactions … ™ Drug-eluting stent Abbott Vascular FDA approved DESyne™ novolimus- eluting stent Drug-eluting stent

318. PROPOSALS FOR A PHASED EVALUATION OF (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/medical-tests-proposals_research.pdf
     January 01, 2009 - Netherlands ii Proposals for a Phased Evaluation of Medical Tests Abstract Background—In drug … Phase 0 studies are exploratory first-in-human trials to evaluate whether the drug or agent behaves … Phase I, the safety, tolerability and toxicity, pharmacodynamics, and pharmacokinetics of the new drug … If the drug is effective, further surveillance after introduction to the market is necessary. … Food and Drug Administration (FDA) noticed a similarity in the evaluation of breast imaging technology

319. PROPOSALS FOR A PHASED EVALUATION OF (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/whitepaper3-lijmer02262010-2.pdf
     January 01, 2009 - Netherlands ii Proposals for a Phased Evaluation of Medical Tests Abstract Background—In drug … Phase 0 studies are exploratory first-in-human trials to evaluate whether the drug or agent behaves … Phase I, the safety, tolerability and toxicity, pharmacodynamics, and pharmacokinetics of the new drug … If the drug is effective, further surveillance after introduction to the market is necessary. … Food and Drug Administration (FDA) noticed a similarity in the evaluation of breast imaging technology

320. Introduction-User-Guide-To-Ocer 130129 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/introduction-user-guide-to-ocer_130129.pdf
     April 26, 2012 - Recognizing the need for outcomes research, Section 1013 of the Medicare Prescription Drug, Improvement … Availability of comparative efficacy data at the time of drug approval in the United States. … Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law No. 108- 173, § 1013 … Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. … Pharmacoepidemiol Drug Saf. 2008;17(2):200-8. 28.