jepcastel > UnitedStatesFoodandDrugAdministration

Publikationen (verstecken)13
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1Methodological recommendations of the Regulatory Agencies.
F. Torres, G. Calvo, und C. Pontes. Medicina clínica, (Dezember 2005)4826<m:linebreak></m:linebreak>JID: 0376377; ppublish;<m:linebreak></m:linebreak>Disseny; Regulació.
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BiomedicalResearch
BiomedicalResearch:standards
ClinicalTrialsasTopic
ClinicalTrialsasTopic:standards
DrugApproval
DrugApproval:organization&administration
DrugEvaluation
DrugEvaluation:standards
Europe
GovernmentAgencies
GuidelinesasTopic
MulticenterStudiesasTopic
Preclinical
Preclinical:standards
Publishing
Publishing:standards
ResearchDesign
ResearchDesign:standards
UnitedStates
UnitedStatesFoodandDrugAdministration
BiomedicalResearchBiomedicalResearch:standardsClinicalTrialsasTopicClinicalTrialsasTopic:standardsDrugApprovalDrugApproval:organization&administrationDrugEvaluationDrugEvaluation:standardsEuropeGovernmentAgenciesGuidelinesasTopicMulticenterStudiesasTopicPreclinicalPreclinical:standardsPublishingPublishing:standardsResearchDesignResearchDesign:standardsUnitedStatesUnitedStatesFoodandDrugAdministration
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1FDA and pharma seek better ways to assess drug safety, efficacy in clinical trials.
M. Mitka. JAMA : the journal of the American Medical Association, 307 (24): 2576-7 (Juni 2012)6793<m:linebreak></m:linebreak>JID: 7501160; ppublish;<m:linebreak></m:linebreak>Intention to treat.
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Bias(Epidemiology)
DataCollection
DataCollection:standards
Drug-RelatedSideEffectsandAdverseReactions
DrugApproval
DrugIndustry
Efficiency
IntentiontoTreatAnalysis
Organizational
ResearchDesign
UnitedStates
UnitedStatesFoodandDrugAdministration
RCT
Bias(Epidemiology)DataCollectionDataCollection:standardsDrug-RelatedSideEffectsandAdverseReactionsDrugApprovalDrugIndustryEfficiencyIntentiontoTreatAnalysisOrganizationalResearchDesignUnitedStatesUnitedStatesFoodandDrugAdministrationRCT
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1Determining the non-inferiority margin for patient reported outcomes.
C. Gerlinger, und T. Schmelter. Pharmaceutical statistics, 10 (5): 410-3 (2011)6376<m:linebreak></m:linebreak>MDCI; Tests d'equivalència; Mesures de resultats.
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AcneVulgaris
AcneVulgaris:drugtherapy
AcneiformEruptions
AcneiformEruptions:drugtherapy
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DiscriminantAnalysis
DiseaseProgression
DrugandNarcoticControl
Endometriosis
Endometriosis:complications
Endometriosis:drugtherapy
Female
HotFlashes
HotFlashes:complications
HotFlashes:drugtherapy
Humans
Internationality
Menopause
Menopause:drugeffects
Models
PatientSatisfaction
PelvicPain
PelvicPain:complications
PharmaceuticalPreparations
PharmaceuticalPreparations:adverseeffects
PharmaceuticalPreparations:metabolism
ROCCurve
ResearchDesign
SelfReport
SelfReport:standards
SensitivityandSpecificity
Statistical
TreatmentOutcome
UnitedStates
UnitedStatesFoodandDrugAdministration
VasomotorSystem
VasomotorSystem:drugeffects
AcneVulgarisAcneVulgaris:drugtherapyAcneiformEruptionsAcneiformEruptions:drugtherapyClinicalTrialsasTopicClinicalTrialsasTopic:methodsDiscriminantAnalysisDiseaseProgressionDrugandNarcoticControlEndometriosisEndometriosis:complicationsEndometriosis:drugtherapyFemaleHotFlashesHotFlashes:complicationsHotFlashes:drugtherapyHumansInternationalityMenopauseMenopause:drugeffectsModelsPatientSatisfactionPelvicPainPelvicPain:complicationsPharmaceuticalPreparationsPharmaceuticalPreparations:adverseeffectsPharmaceuticalPreparations:metabolismROCCurveResearchDesignSelfReportSelfReport:standardsSensitivityandSpecificityStatisticalTreatmentOutcomeUnitedStatesUnitedStatesFoodandDrugAdministrationVasomotorSystemVasomotorSystem:drugeffects
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1Medicine. Moving toward transparency of clinical trials.
D. Zarin, und T. Tse. Science (New York, N.Y.), 319 (5868): 1340-2 (März 2008)4974<m:linebreak></m:linebreak>LR: 20081120; GR: NIH0010298972/PHS HHS/United States; JID: 0404511; CIN: Science. 2008 Oct 3;322(5898):44-6. PMID: 18832629; NIHMS41213; OID: NLM: NIHMS41213; OID: NLM: PMC2396952; ppublish;<m:linebreak></m:linebreak>Recursos/Organització; Recerca clínica.
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AccesstoInformation
AdverseDrugReactionReportingSystems
ClinicalTrialsasTopic
ClinicalTrialsasTopic:legislation&jurisprude
ClinicalTrialsasTopic:standards
Databases
Disclosure
Factual
Humans
IntellectualProperty
Postmarketing
ProductSurveillance
PublicPolicy
Publishing
Registries
UnitedStates
UnitedStatesFoodandDrugAdministration
UnitedStatesFoodandDrugAdministration:legisl
AccesstoInformationAdverseDrugReactionReportingSystemsClinicalTrialsasTopicClinicalTrialsasTopic:legislation&jurisprudeClinicalTrialsasTopic:standardsDatabasesDisclosureFactualHumansIntellectualPropertyPostmarketingProductSurveillancePublicPolicyPublishingRegistriesUnitedStatesUnitedStatesFoodandDrugAdministrationUnitedStatesFoodandDrugAdministration:legisl
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1FDA draft guidance and health-outcomes research.
D. Revicki. Lancet, 369 (9561): 540-2 (Februar 2007)4766<m:linebreak></m:linebreak>LR: 20071115; JID: 2985213R; ppublish;<m:linebreak></m:linebreak>Mesures de resultats.
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ClinicalTrialsasTopic
DrugApproval
DrugApproval:methods
HealthPlanningGuidelines
Humans
OutcomeandProcessAssessment(HealthCare)
OutcomeandProcessAssessment(HealthCare):orga
QualityofLife
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsasTopicDrugApprovalDrugApproval:methodsHealthPlanningGuidelinesHumansOutcomeandProcessAssessment(HealthCare)OutcomeandProcessAssessment(HealthCare):orgaQualityofLifeUnitedStatesUnitedStatesFoodandDrugAdministration
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1Benefits, challenges and obstacles of adaptive clinical trial designs.
S. Chow, und R. Corey. Orphanet journal of rare diseases, (Januar 2011)6593<m:linebreak></m:linebreak>GR: 2P30 AI064518/AI/NIAID NIH HHS/United States; JID: 101266602; OID: NLM: PMC3248853; 2011/08/22 received; 2011/11/30 accepted; 2011/11/30 aheadofprint; epublish;<m:linebreak></m:linebreak>Tipus d'estudis; Dissenys adaptatius.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
DataInterpretation
Dose-ResponseRelationship
Drug
DrugIndustry
DrugIndustry:standards
EndpointDetermination
Humans
ResearchDesign
SampleSize
Statistical
TreatmentOutcome
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsDataInterpretationDose-ResponseRelationshipDrugDrugIndustryDrugIndustry:standardsEndpointDeterminationHumansResearchDesignSampleSizeStatisticalTreatmentOutcomeUnitedStatesUnitedStatesFoodandDrugAdministration
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1Observational evidence for determining drug safety.
N. Freemantle, und A. Irs. BMJ (Clinical research ed.), 336 (7645): 627-8 (März 2008)4986<m:linebreak></m:linebreak>LR: 20081120; JID: 8900488; CIN: BMJ. 2008 Apr 5;336(7647):735. PMID: 18390501; OID: NLM: PMC2270986; ppublish;.
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DrugToxicity
UnitedStates
UnitedStatesFoodandDrugAdministration
RCT
DrugToxicityUnitedStatesUnitedStatesFoodandDrugAdministrationRCT
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1Clinical and outcome research in oncology. The need for integration.
G. Apolone. Health and quality of life outcomes, (Januar 2003)5220<m:linebreak></m:linebreak>JID: 101153626; 0 (Antineoplastic Agents); OID: NLM: PMC155672; 2003/02/27 received; 2003/04/03 accepted; 2003/04/03 aheadofprint; epublish;<m:linebreak></m:linebreak>Mesures de resultats.
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AntineoplasticAgents
AntineoplasticAgents:therapeuticuse
BiomedicalResearch
BiomedicalResearch:methods
ClinicalTrialsasTopic
DrugApproval
Europe
Humans
MedicalOncology
Neoplasms
Neoplasms:drugtherapy
OutcomeAssessment(HealthCare)
OutcomeAssessment(HealthCare):methods
QualityofLife
UnitedStates
UnitedStatesFoodandDrugAdministration
AntineoplasticAgentsAntineoplasticAgents:therapeuticuseBiomedicalResearchBiomedicalResearch:methodsClinicalTrialsasTopicDrugApprovalEuropeHumansMedicalOncologyNeoplasmsNeoplasms:drugtherapyOutcomeAssessment(HealthCare)OutcomeAssessment(HealthCare):methodsQualityofLifeUnitedStatesUnitedStatesFoodandDrugAdministration
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1What can we really learn from observational studies?: the need for empirical assessment of methodology for active drug safety surveillance and comparative effectiveness research.
D. Madigan, und P. Ryan. Epidemiology (Cambridge, Mass.), 22 (5): 629-31 (September 2011)6412<m:linebreak></m:linebreak>JID: 9009644; CIN: Epidemiology. 2011 Sep;22(5):636-7. PMID: 21811112; ppublish;<m:linebreak></m:linebreak>CER.
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ComparativeEffectivenessResearch
ComparativeEffectivenessResearch:methods
DrugEvaluation
DrugEvaluation:methods
EmpiricalResearch
EpidemiologicMethods
Observation
Pharmacoepidemiology
Pharmacoepidemiology:methods
Postmarketing
Postmarketing:methods
ProductSurveillance
UnitedStates
UnitedStatesFoodandDrugAdministration
ComparativeEffectivenessResearchComparativeEffectivenessResearch:methodsDrugEvaluationDrugEvaluation:methodsEmpiricalResearchEpidemiologicMethodsObservationPharmacoepidemiologyPharmacoepidemiology:methodsPostmarketingPostmarketing:methodsProductSurveillanceUnitedStatesUnitedStatesFoodandDrugAdministration
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1Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.
P. Gallo, C. Chuang-Stein, V. Dragalin, B. Gaydos, M. Krams, und J. Pinheiro. Journal of biopharmaceutical statistics, 16 (3): 275-83; discussion 285-91, 293-8, 311-2 (Mai 2006)5002<br/>LR: 20071115; JID: 9200436; CIN: J Biopharm Stat. 2006 May;16(3):299-309; discussion 311-2. PMID: 16724486; ppublish;<br/>Tipus d'estudis; Dissenys adaptatius.
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BiomedicalResearch
ClinicalTrialsDataMonitoringCommittees
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
DataInterpretation
Dose-ResponseRelationship
Drug
DrugIndustry
DrugIndustry:standards
GuidelinesasTopic
Humans
ResearchDesign
SampleSize
Statistical
UnitedStates
UnitedStatesFoodandDrugAdministration
UnitedStatesFoodandDrugAdministration:standa
BiomedicalResearchClinicalTrialsDataMonitoringCommitteesClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsDataInterpretationDose-ResponseRelationshipDrugDrugIndustryDrugIndustry:standardsGuidelinesasTopicHumansResearchDesignSampleSizeStatisticalUnitedStatesUnitedStatesFoodandDrugAdministrationUnitedStatesFoodandDrugAdministration:standa
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1Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.
J. Fries, und E. Krishnan. Arthritis research & therapy, 6 (3): R250-5 (Januar 2004)3835<m:linebreak></m:linebreak>Mesures de contrast.
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Bias(Epidemiology)
DecisionTheory
Ethics
Humans
PersonalAutonomy
PublicationBias
PublicationBias:trends
Research
ResearchDesign
Rheumatology
Rheumatology:ethics
Rheumatology:methods
Rheumatology:statistics&numericaldata
Rheumatology:trends
Uncertainty
UnitedStates
UnitedStatesFoodandDrugAdministration
RCT
Bias(Epidemiology)DecisionTheoryEthicsHumansPersonalAutonomyPublicationBiasPublicationBias:trendsResearchResearchDesignRheumatologyRheumatology:ethicsRheumatology:methodsRheumatology:statistics&numericaldataRheumatology:trendsUncertaintyUnitedStatesUnitedStatesFoodandDrugAdministrationRCT
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1Ethics and regulatory complexities for pragmatic clinical trials.
J. Sugarman, und R. Califf. JAMA : the journal of the American Medical Association, 311 (23): 2381-2 (Juni 2014)Disseny; RCT; Estudis pragmàtics; Ètica.
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ComparativeEffectivenessResearch
ComparativeEffectivenessResearch:ethics
ComparativeEffectivenessResearch:legislation&
EthicsCommittees
Evidence-BasedMedicine
GovernmentRegulation
Humans
InformedConsent
InformedConsent:ethics
Off-LabelUse
PragmaticClinicalTrialsasTopic
PragmaticClinicalTrialsasTopic:ethics
PragmaticClinicalTrialsasTopic:legislation&
Research
ResearchSubjects
RiskAssessment
UnitedStates
UnitedStatesFoodandDrugAdministration
ComparativeEffectivenessResearchComparativeEffectivenessResearch:ethicsComparativeEffectivenessResearch:legislation&EthicsCommitteesEvidence-BasedMedicineGovernmentRegulationHumansInformedConsentInformedConsent:ethicsOff-LabelUsePragmaticClinicalTrialsasTopicPragmaticClinicalTrialsasTopic:ethicsPragmaticClinicalTrialsasTopic:legislation&ResearchResearchSubjectsRiskAssessmentUnitedStatesUnitedStatesFoodandDrugAdministration
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1The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.
R. O'Neill, und R. Temple. Clinical pharmacology and therapeutics, 91 (3): 550-4 (März 2012)Dades censurades; RCT; Regulació; Imputació múltiple; LOCF.
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ClinicalTrialsDataMonitoringCommittees
ClinicalTrialsasTopic
ClinicalTrialsasTopic:standards
DataInterpretation
DrugApproval
Humans
InformationStorageandRetrieval
Statistical
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsDataMonitoringCommitteesClinicalTrialsasTopicClinicalTrialsasTopic:standardsDataInterpretationDrugApprovalHumansInformationStorageandRetrievalStatisticalUnitedStatesUnitedStatesFoodandDrugAdministration
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Publikationen (verstecken)13
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1Methodological recommendations of the Regulatory Agencies.

1FDA and pharma seek better ways to assess drug safety, efficacy in clinical trials.

1Determining the non-inferiority margin for patient reported outcomes.

1Medicine. Moving toward transparency of clinical trials.

1FDA draft guidance and health-outcomes research.

1Benefits, challenges and obstacles of adaptive clinical trial designs.

1Observational evidence for determining drug safety.

1Clinical and outcome research in oncology. The need for integration.

1What can we really learn from observational studies?: the need for empirical assessment of methodology for active drug safety surveillance and comparative effectiveness research.

1Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.

1Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development.

1Ethics and regulatory complexities for pragmatic clinical trials.

1The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

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