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Active Surveillance of Follow-on Biologics: A Prescription for Uptake.
Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Sarpatwari A, et al. Drug Saf. 2017 Feb;40(2):105-108. doi: 10.1007/s40264-016-0471-4. Drug Saf. 2017. PMID: 27838823
As lower-cost versions of original biologic drugs made by different manufacturers, follow-on biologics offer the promise of meaningful savings for the US health care system and improved patient health outcomes through greater medication adherence. ...
As lower-cost versions of original biologic drugs made by different manufacturers, follow-on biologics offer the promise of meaningfu
The rise and fall of Natrecor for congestive heart failure: implications for drug policy.
Kesselheim AS, Fischer MA, Avorn J. Kesselheim AS, et al. Health Aff (Millwood). 2006 Jul-Aug;25(4):1095-102. doi: 10.1377/hlthaff.25.4.1095. Health Aff (Millwood). 2006. PMID: 16835191
We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians' prescribing choices can shape the risk-benefit relationship of new drugs. ...
We use it as a case study to assess how FDA standards for drug approval, marketing practices by drug manufacturers, and physicians' p …
The role of litigation in defining drug risks.
Kesselheim AS, Avorn J. Kesselheim AS, et al. JAMA. 2007 Jan 17;297(3):308-11. doi: 10.1001/jama.297.3.308. JAMA. 2007. PMID: 17227983 No abstract available.
Scientific and legal viability of follow-on protein drugs.
Dudzinski DM, Kesselheim AS. Dudzinski DM, et al. N Engl J Med. 2008 Feb 21;358(8):843-9. doi: 10.1056/NEJMhle0706973. N Engl J Med. 2008. PMID: 18287608 No abstract available.
The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.
Kesselheim AS, Choudhry NK. Kesselheim AS, et al. Ann Intern Med. 2008 Apr 15;148(8):614-9. doi: 10.7326/0003-4819-148-8-200804150-00006. Ann Intern Med. 2008. PMID: 18413623
As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription d
As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importati
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.
Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. Kesselheim AS, et al. JAMA. 2008 Dec 3;300(21):2514-26. doi: 10.1001/jama.2008.758. JAMA. 2008. PMID: 19050195 Free PMC article. Review.
For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. RESULTS: We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). ...
For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. RESULTS: We identified 4 …
442 results
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