- NLM Digital Collections - Expansion cohorts : use in first-in-human clinical trials to expedite development of oncology ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022... avoid medication errors when treatment plans differ by cohort (dose-escalation versus dose-expansion and between individual expansion ...
- NLM Digital Collections - Proton beam therapy : final evidence reportPublication: [Boston, MA] : Institute for Clinical and Economic Review, [2014]... DCH, Grade I: 43% therapeutic Study Objective Overall cohort • Dose: 16-30 Gy, of PBT vs. photon modality ...
- NLM Digital Collections - Abuse-deterrent formulations of opioids : effectiveness and value : final evidence reportPublication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, August 8, 2017... to 60mg and 90mg in up to two cohorts. Dose determination based on drug liking bipolar VAS. Drug ... years; enrolled Opioid dispensing rate, mg morphine equivalent dose per JAMA 2015 72 ... using an open cohort 3) other long acting used Optum data which ...
- NLM Digital Collections - Smoking cessation and related indications : developing nicotine replacement therapy drug ...Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023... should be established in the relevant pediatric age cohort. Dose selection in pediatric patients should be based on ...
- NLM Digital Collections - Spinraza and Zolgensma for spinal muscular atrophy : effectiveness and value : final evidence ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, May 24, 2019... Zolgensma. This Executive Summary focuses on the high-dose cohort only; results from the low-dose cohort are described in Section 3. We did not ... results from the 12 infants in the high- dose cohort. Baseline Characteristics of Key Trials Key baseline characteristics ...
- NLM Digital Collections - Valoctocogene roxaparvovec and emicizumab for hemophilia A without inhibitors : effectiveness ...Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, November 20, 2020... IU/dl or greater.14 In the higher dose cohort, the mean annualized bleeding rate (ABR) for treated ... emotional impact, and treatment concerns. In the higher dose cohort, a steady improvement was seen in the Haemo- ...
- NLM Digital Collections - Acute myeloid leukemia developing drugs and biological products for treatment : guidance for ....Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022... to proceed with escalating the dose in subsequent cohorts. For dose-escalation trials of conventional outpatient chemotherapy for patients ... dose has been established as safe in subsequent cohorts. The protocol should ... for when intra-patient dose escalation is allowed, how the new dose is ...
- NLM Digital Collections - Human gene therapy for rare diseasesPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020... initial group of subjects, followed by staggering between dose cohorts. This approach limits the number of subjects who ... optimal dosing interval between consecutively enrolled subjects and dose cohorts should be discussed with OTAT prior to beginning ...
- NLM Digital Collections - The Health Consequences of Involuntary Smoking: A Report of the Surgeon GeneralPublication: United States. Office on Smoking and Health, 1986... 1976b) subse- quently reported that, in this same cohort, a dose-response relation- ship with parental smoking persisted for ... vs. whole sidestream smoke, 236-238 lung cancer dose-response relation- ship, ... Cancer Society Cohort Study, 76-77 lung cancer risk assessment, impor- ...
- NLM Digital Collections - The Health Consequences of Involuntary Smoking: A Report of the Surgeon General (pages 26-50)Publication: United States. Office on Smoking and Health, 1986... 1976b) subse- quently reported that, in this same cohort, a dose-response relation- ship with parental smoking persisted for ...
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