Notes in Phar 221

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Status	Last Update	Fields
Published	02/25/2024	ReliabilityResults obtained from a measurement instrument should be {{c1::consistent}} and {{c1::repeatable (reproducible)}} over timeReliab…
Published	02/25/2024	Types of reliability{{c3::Test-retest}}reliability: How {{c1::similarly}} does a test or scale perform over {{c1::repeated administration}}{…
Published	02/25/2024	both of the targets have {{c1::high}} reliability because all the shots are {{c1::closely grouped together }}
Published	02/25/2024	validity  The degree of how {{c1::correct/accurate}} a measurement isDiffers from reliability because reliability is all about whether the m…
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Published	02/25/2024	study validityThe degree to which the findings of a study are {{c1::correct}}Related to validity in that we are looking at whether the measuremen…
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Published	02/25/2024	internal validityThe extent to which the {{c1::outcome of the study}} can be explained by the {{c1::intervention}}How to increase internal v…
Published	02/25/2024	Things that decrease internal validityNo {{c1::control group}} or no {{c1::randomization}}{{c1::Attrition}}: {{c2::loss}} of study subjects …
Published	02/25/2024	external validity -- the extent to which the study results can be {{c1::generalized}} to other {{c2::settings}} or {{c2::populations}}
Published	02/25/2024	How to increase external validity{{c1::Broad}}{{c2:: inclusion criteria}}{{c1::Fewer}} {{c2::exclusion criteria}}Designing study to {{c1::mi…
Published	02/25/2024	Things that decrease external validity{{c1::Hawthorne}} effect{{c1::Stringently controlled}}experiment settings{{c2::Narrow}}{{c3:: inclusio…
Published	02/25/2024	internal vs externalMany of the things that {{c1::increase}} internal validity will {{c1::decrease}} external validityInternal is usually {{…
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Published	02/25/2024	Intent to Treat (ITT) analysisAll participants should be analyzed in the {{c1::group to which they were randomized}}Investigators include them in…
Published	02/25/2024	ITT analysisFor individuals who {{c1::drop out}} before the end of the study, you use “{{c1::last observation carried forward}}” (LOCF) when incl…
Published	02/25/2024	Per protocol (PP) analysisOnly individuals who have {{c1::completed all aspects of the protocol (correctly)}} are included in the analysisWill ha…
Published	02/25/2024	titleShould be {{c1::balanced}} and {{c1::unbiased}}Should make {{c2::no directional claims}} about the contentsE.g. “Drug A cures urin…
Published	02/25/2024	abstract{{c1::Summary}} of the article contentsUsually contains one or more of the following…{{c1::Background}}{{c1::Objective}}{{c2::Methods}}{{…
Published	02/25/2024	introductionAka {{c1::Background}}Does not always have a {{c1::header}}Should include {{c1::background}} and {{c1::rationale}…
Published	02/25/2024	methodsMeant to show other researchers/peer reviewers how the experiment was performed so that it can be {{c1::replicated}} and {{c1::assessed}}&…
Published	02/25/2024	outcomes{{c1::Outcome variables}} are measurements that are most likely to {{c2::directly result from the study intervention}}Should be link…
Published	02/25/2024	outcomes by importance{{c1::Primary}}{{c2::Main}} outcome of interest (usually related to {{c2::efficacy}} for drug trials) should be o…
Published	02/25/2024	A Priori – “from {{c1::before}}”Outcomes that were {{c1::planned prior}} to the start of the trialMost, if not all, outcomes of a study are …
Published	02/25/2024	Post-Hoc – “{{c1::after}} the event”Outcomes that were {{c1::planned/specified AFTER the trial has started}}Post-hoc analyses can be thought…
Published	02/25/2024	statistical analysisShould provide the investigators’ {{c1::reasoning}} behind their statisticsIncludesSample {{c1::size}} and reasoning{{c1…
Published	02/25/2024	resultsSection where the authors tell you {{c1::what occurred during their study}}Essentially a historical {{c1::record}} of what occurred, …
Published	02/25/2024	endpointsEndpoints should relate to the topic so that it’s a reasonable way to assess the disease state/condition being studiedEndpoints are categoriz…
Published	02/25/2024	clinical endpointsAny outcome that represents {{c1::DISEASE}} or {{c1::SYMPTOMS}}Direct measure of how a patient {{c2::feels}}, {{c2::functi…
Published	02/25/2024	surrogate endpoints{{c1::Indirect}} measures of clinically meaningful endpoints{{c1::Lab measurements}}or other measurements that could be correl…
Published	02/25/2024	composite endpointsCaptures the {{c1::number of patients}} experiencing one or more of several outcomesCombines several {{c1::clinical (usually)}…
Published	02/25/2024	discussionOccasionally called “{{c1::Conclusions}}” – or can have a separate conclusion sectionCan be the {{c1::most biased}} part of the article…
Published	02/25/2024	discussionSummary of results may include{{c1::What this study added}} to current research{{c1::Strengths}} of the research{{c1::Summary}}&nb…
Published	02/25/2024	journal clubAn organized means of conveying {{c1::information from an article}} to othersMay involve {{c1::handouts/powerpoints}}Depth …
Published	02/25/2024	Mortality -- Incidence of {{c1::death}}Morbidity -- Incidence or evidence of {{c1::illness due to a disease}}In the case of C…
Published	02/25/2024	supplementary appendixDo I need to read the supplementary appendix?Short answer: YesLong answer: Highly likely because the supplementary appendix usua…
Published	02/25/2024	Noninferiority - hypothesis testing to demonstrate that a treatment or intervention is {{c1::not worse}} than a standard/ established t…
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Published	02/25/2024	When do we use non-inferiority?When a drug needs to be {{c1::no worse}} than the health standard  used when a company is putting out an…
Published	02/25/2024	assumptions and dangers of noninferiorityAssumption: New treatment offers {{c1::advantages}} to standard care Assumption: New treatment is {…
Published	02/25/2024	survival analysesSurvival analysis: Statistics used to study {{c1::timing of an occurrence or event}}E.g. Time to first MI, time to first hip fra…
Published	02/25/2024	Drug development involves a {{c1::long series of trials}} to verify that a medication is {{c2::safe}} and {{c2::efficacious}}These tria…
Published	02/25/2024	preclinical studies{{c1::Suitable drug candidates}} identified in labs{{c2::Lab testing}}Identification of{{c3::likely molecules}}{{c2::Animal te…
Published	02/25/2024	Phase 1 purpose
Published	02/25/2024	phase 1 population
Published	02/25/2024	Phase 1 design and goal study type:{{c1:: Dose escalation/dose determining}} study- {{c1::unblinded}} and {{c1::uncontrolled}}goal: - f…
Published	02/25/2024	phase 1 duration -- {{c1::1 month to less than a year }}
Published	02/25/2024	phase 1 enrollees - {{c1::small}} size study ~ {{c2::50}} subjects
Published	02/25/2024	phase 2Purpose: Generate initial data on {{c1::safety/toxicity}} and {{c1::efficacy}} of the medicationAlso collects {{c2::PK}}, {{c2::PD}},…
Published	02/25/2024	phase 3Purpose: Generate {{c1::efficacy}} and {{c1::safety}} data to allow evaluation of {{c2::overall risk-benefit}} of the drugPurpos…
Published	02/25/2024	Phase 4Aka {{c1::post-marketing}} studiesPurpose: Intended to generate{{c1::longer-term safety/toxicity}} dataMay allow researchers to identify&n…
Status	Last Update	Fields