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4,855 results
  1. NLM Digital Collections - M4E(R2) : the CTD--efficacy 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
    resource.nlm.nih.gov/101713111
    ... 5 Appendix ................................................................................................................................... 26 2.7.3 SUMMARY OF CLINICAL EFFICACY .................................................................... 27 2.7.3.1 Background and Overview of Clinical Efficacy.................................................................... 27 2.7.3.2 Summary of Results ...
  2. NLM Digital Collections - Targeted immune modulators for rheumatoid arthritis : effectiveness and value : evidence ... 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, April 7, 2017
    resource.nlm.nih.gov/101723892
    ... P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of ... JM, Blanco R, Halland A-M, et al. Clinical efficacy and safety maintained up to 5 years in ...
  3. NLM Digital Collections - Vesicular monoamine transporter 2 inhibitors for tardive dyskinesia : effectiveness and value ... 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, December 22, 2017
    resource.nlm.nih.gov/101723938
    ... C, Cole JO. Treatment of tardive dyskinesia. I. Clinical efficacy of a dopamine-depleting agent, tetrabenazine. Archives of ... chemistry, animal pharmacology and toxicology, human pharmacology, and clinical efficacy. Pharmacotherapy. 1981;1(3):163-178. 40. Carbon ...
  4. NLM Digital Collections - Cumulative index of hospital literature (1975-1977) 
    resource.nlm.nih.gov/60120460RX7
    ... in- formation and first attempt at measuring its clinical efficacy. J.J.McCoy and J.M.Sinacore. Ill ... in- formation and first attempt at measuring its clinical efficacy. J.J.McCoy and J.M.Sinacore. Ill ...
  5. NLM Digital Collections - Targeted immune modulators for ulcerative colitis : effectiveness and value : final evidence .... 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, October 16, 2020
    resource.nlm.nih.gov/9918402188306676
    ... Outcomes The following outcomes of interest were evaluated: Efficacy • Clinical remission • Clinical response • Endoscopic improvement (often referred to ... Remission at 16 Weeks for the Extended Induction Efficacy Scenario Clinical Response Clinical Remission Source without Remission Adalimumab No ...
  6. NLM Digital Collections - Considerations in demonstrating interchangeability with a reference product 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
    resource.nlm.nih.gov/101760108
    ... and PD (if available) endpoints, as distinguished from clinical efficacy endpoints, are generally more likely to be sensitive ... endpoints can be supportive, at therapeutic doses many clinical efficacy endpoints would generally be less sensitive to detect ...
  7. NLM Digital Collections - COVID-19 : developing drugs and biological products for treatment or prevention 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
    resource.nlm.nih.gov/9918231202706676
    ... individuals should be enrolled in the phase 3 (efficacy) clinical trials when appropriate. 14 – FDA encourages enrolling lactating individuals in phase 3 (efficacy) clinical trials. – Children should not be categorically excluded from ...
  8. NLM Digital Collections - Report of the Blood Transfusion Association Concerning the Project for Supplying Blood Plasma ... 
    Publication: Produced: 31 January 1941
    resource.nlm.nih.gov/101584649X141
    ... less than half its normal content and its clinical efficacy will be reduced in proportion. 3. The diameter ... experimental program to determine the relative toxicity and clinical efficacy of plasma and serum in their liquid and ...
  9. NLM Digital Collections - Index-catalogue of the Library of the Surgeon General's Office, United States Army (Series 4, ... 
    Publication: Washington : U.S. G.P.O., 1936-1948
    resource.nlm.nih.gov/8104688X10
    ... 8.—Hicks, E. P., & Diwan Chand. The relative clinical efficacy of totaquina and quinine. Rec. Malaria Surv. India, ...
  10. NLM Digital Collections - Economic analysis of availability of follow-on protein products : final report 
    Publication: [Washington, DC] : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, 2009
    resource.nlm.nih.gov/101615134
    ... by-case approach to regulate FoPPs, requiring some clinical efficacy and safety data for market approval. At the ... by-case approach in regulating FoPPs, requiring some clinical efficacy and safety data for market approval. As implemented ...
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