jepcastel > DrugApproval humans

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1Post-approval drug safety surveillance.
R. Gibbons, A. Amatya, C. Brown, K. Hur, S. Marcus, D. Bhaumik, and J. Mann. Annual review of public health, 31 (1): 419-37 (January 2010)5576<m:linebreak></m:linebreak>doi: 10.1146/annurev.publhealth.012809.103649;.
2 years ago by @jepcastel
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AntidepressiveAgents
AntidepressiveAgents:adverseeffects
Attempted
Attempted:statistics&numericaldata
Drug-RelatedSideEffectsandAdverseReactions
DrugApproval
Female
Humans
Male
Meta-AnalysisasTopic
PoissonDistribution
PopulationSurveillance
PropensityScore
Suicide
RCT
AntidepressiveAgentsAntidepressiveAgents:adverseeffectsAttemptedAttempted:statistics&numericaldataDrug-RelatedSideEffectsandAdverseReactionsDrugApprovalFemaleHumansMaleMeta-AnalysisasTopicPoissonDistributionPopulationSurveillancePropensityScoreSuicideRCT
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1Pharmacovigilance: a science or fielding emergencies?
S. Evans. Statistics in medicine, 19 (23): 3199-209 (December 2000)2871<m:linebreak></m:linebreak>Mesures d'associació.
2 years ago by @jepcastel
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Drug-RelatedSideEffectsandAdverseReactions
DrugApproval
DrugApproval:legislation&jurisprudence
DrugApproval:methods
Europe
GreatBritain
Humans
Postmarketing
Postmarketing:methods
ProductSurveillance
StatisticsasTopic
StatisticsasTopic:methods
UnitedStates
Drug-RelatedSideEffectsandAdverseReactionsDrugApprovalDrugApproval:legislation&jurisprudenceDrugApproval:methodsEuropeGreatBritainHumansPostmarketingPostmarketing:methodsProductSurveillanceStatisticsasTopicStatisticsasTopic:methodsUnitedStates
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1Number of patients studied prior to approval of new medicines: a database analysis.
R. Duijnhoven, S. Straus, J. Raine, A. de Boer, A. Hoes, и M. Bruin. PLoS medicine, 10 (3): e1001407 (January 2013)M3: doi:10.1371/journal.pmed.1001407;.
2 лет назад , @jepcastel
ChronicDisease
Databases
DrugApproval
DrugApproval:economics
DrugApproval:statistics&numericaldata
Factual
Humans
Marketing
Marketing:economics
PatientParticipation
PatientParticipation:economics
PatientParticipation:statistics&numericaldata
SampleSize
TimeFactors
ChronicDiseaseDatabasesDrugApprovalDrugApproval:economicsDrugApproval:statistics&numericaldataFactualHumansMarketingMarketing:economicsPatientParticipationPatientParticipation:economicsPatientParticipation:statistics&numericaldataSampleSizeTimeFactors
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1Comparative efficacy and effectiveness: an opportunity for clinical pharmacology.
R. Lalonde, и R. Willke. Clinical pharmacology and therapeutics, 90 (6): 761-3 (December 2011)6577<m:linebreak></m:linebreak>JID: 0372741; 0 (Drugs, Generic); ppublish;<m:linebreak></m:linebreak>CER.
2 лет назад , @jepcastel
Clinical
Clinical:methods
ComparativeEffectivenessResearch
ComparativeEffectivenessResearch:organization&
DrugApproval
DrugDesign
DrugIndustry
DrugIndustry:economics
DrugIndustry:organization&administration
Drugs
Generic
Generic:economics
HealthCareCosts
HealthServicesNeedsandDemand
Humans
Pharmacology
ReimbursementMechanisms
UnitedStates
ClinicalClinical:methodsComparativeEffectivenessResearchComparativeEffectivenessResearch:organization&DrugApprovalDrugDesignDrugIndustryDrugIndustry:economicsDrugIndustry:organization&administrationDrugsGenericGeneric:economicsHealthCareCostsHealthServicesNeedsandDemandHumansPharmacologyReimbursementMechanismsUnitedStates
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1FDA draft guidance and health-outcomes research.
D. Revicki. Lancet, 369 (9561): 540-2 (February 2007)4766<m:linebreak></m:linebreak>LR: 20071115; JID: 2985213R; ppublish;<m:linebreak></m:linebreak>Mesures de resultats.
2 лет назад , @jepcastel
ClinicalTrialsasTopic
DrugApproval
DrugApproval:methods
HealthPlanningGuidelines
Humans
OutcomeandProcessAssessment(HealthCare)
OutcomeandProcessAssessment(HealthCare):orga
QualityofLife
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsasTopicDrugApprovalDrugApproval:methodsHealthPlanningGuidelinesHumansOutcomeandProcessAssessment(HealthCare)OutcomeandProcessAssessment(HealthCare):orgaQualityofLifeUnitedStatesUnitedStatesFoodandDrugAdministration
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1Clinical and outcome research in oncology. The need for integration.
G. Apolone. Health and quality of life outcomes, (January 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.
2 лет назад , @jepcastel
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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1The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.
R. O'Neill, и R. Temple. Clinical pharmacology and therapeutics, 91 (3): 550-4 (March 2012)Dades censurades; RCT; Regulació; Imputació múltiple; LOCF.
2 лет назад , @jepcastel
ClinicalTrialsDataMonitoringCommittees
ClinicalTrialsasTopic
ClinicalTrialsasTopic:standards
DataInterpretation
DrugApproval
Humans
InformationStorageandRetrieval
Statistical
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsDataMonitoringCommitteesClinicalTrialsasTopicClinicalTrialsasTopic:standardsDataInterpretationDrugApprovalHumansInformationStorageandRetrievalStatisticalUnitedStatesUnitedStatesFoodandDrugAdministration
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1Post-approval drug safety surveillance.

1Pharmacovigilance: a science or fielding emergencies?

1Number of patients studied prior to approval of new medicines: a database analysis.

1Comparative efficacy and effectiveness: an opportunity for clinical pharmacology.

1FDA draft guidance and health-outcomes research.

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

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

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