2023
Value of Antibody Drug Conjugates for Gynecological Cancers: A Modern Appraisal Following Recent FDA Approvals
McNamara B, Chang Y, Goreshnik A, Santin A. Value of Antibody Drug Conjugates for Gynecological Cancers: A Modern Appraisal Following Recent FDA Approvals. International Journal Of Women's Health 2023, 15: 1353-1365. PMID: 37663226, PMCID: PMC10474218, DOI: 10.2147/ijwh.s400537.Peer-Reviewed Original ResearchAntibody-drug conjugatesReceptor-targeting antibodiesOngoing clinical trialsDrug conjugatesRelevant preclinical studiesRecent FDA approvalAnti-cancer therapyGynecologic malignanciesCytotoxic therapyGynecological cancerADC therapyClinical trialsPreclinical studiesFDA approvalTumor cellsTherapyHealthy tissueModern appraisalDeliveryMalignancyCancerConjugatesTrialsAntibodies
2020
Chapter Four Clinical overview of NMDA-R antagonists and clinical practice
Davoudian PA, Wilkinson ST. Chapter Four Clinical overview of NMDA-R antagonists and clinical practice. Advances In Pharmacology 2020, 89: 103-129. PMID: 32616204, DOI: 10.1016/bs.apha.2020.04.004.ChaptersConceptsNMDA receptor antagonistReceptor antagonistGlutamatergic systemClinical trialsPathophysiology of depressionLevels of monoaminesNMDA-R antagonistsTreatment of depressionRole of glutamatePatient's therapeutic responseRecent FDA approvalIntranasal esketamineMonoamine hypothesisPathophysiological mechanismsClinical overviewTherapeutic responseCurrent treatmentClinical practiceTranslational studiesMental illnessFDA approvalNeural circuitsAntagonistDepressionPotential mechanismsAssessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017. JAMA Network Open 2020, 3: e203284. PMID: 32315070, PMCID: PMC7175081, DOI: 10.1001/jamanetworkopen.2020.3284.Peer-Reviewed Original ResearchConceptsPivotal trialsProportion of indicationsIndication approvalsNew drugsUS FoodTrial durationPrimary end pointTherapeutic areasPivotal efficacy trialsCross-sectional studyDrug Administration approvalFast track designationCommon therapeutic areasRecent FDA approvalOrphan designationLonger trial durationAccelerated approvalAdministration approvalClinical trialsMonths durationEfficacy trialsMAIN OUTCOMETherapeutic safetyDrug AdministrationFDA approval
2019
Transcranial electrical and magnetic stimulation (tES and TMS) for addiction medicine: A consensus paper on the present state of the science and the road ahead
Ekhtiari H, Tavakoli H, Addolorato G, Baeken C, Bonci A, Campanella S, Castelo-Branco L, Challet-Bouju G, Clark VP, Claus E, Dannon PN, Del Felice A, den Uyl T, Diana M, di Giannantonio M, Fedota JR, Fitzgerald P, Gallimberti L, Grall-Bronnec M, Herremans SC, Herrmann MJ, Jamil A, Khedr E, Kouimtsidis C, Kozak K, Krupitsky E, Lamm C, Lechner WV, Madeo G, Malmir N, Martinotti G, McDonald W, Montemitro C, Nakamura-Palacios EM, Nasehi M, Noël X, Nosratabadi M, Paulus M, Pettorruso M, Pradhan B, Praharaj SK, Rafferty H, Sahlem G, Salmeron BJ, Sauvaget A, Schluter RS, Sergiou C, Shahbabaie A, Sheffer C, Spagnolo PA, Steele VR, Yuan TF, van Dongen J, Van Waes V, Venkatasubramanian G, Verdejo-García A, Verveer I, Welsh J, Wesley MJ, Witkiewitz K, Yavari F, Zarrindast MR, Zawertailo L, Zhang X, Cha YH, George TP, Frohlich F, Goudriaan AE, Fecteau S, Daughters SB, Stein EA, Fregni F, Nitsche MA, Zangen A, Bikson M, Hanlon CA. Transcranial electrical and magnetic stimulation (tES and TMS) for addiction medicine: A consensus paper on the present state of the science and the road ahead. Neuroscience & Biobehavioral Reviews 2019, 104: 118-140. PMID: 31271802, PMCID: PMC7293143, DOI: 10.1016/j.neubiorev.2019.06.007.Peer-Reviewed Original ResearchConceptsSubstance use disordersNon-invasive brain stimulationConsensus paperAddiction medicineNovel treatment optionsMental health disordersTranscranial magnetic stimulationRecent FDA approvalHeterogeneity of methodsNIBS treatmentTreatment optionsFuture therapiesMagnetic stimulationBrain stimulationPreclinical neuroscienceClinical practiceHealth disordersFDA approvalNeural circuitsNeuromodulation toolBasic neuroscienceSUD researchStimulationSystematic literature reviewDisorders
2018
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials 2018, 19: 581. PMID: 30352601, PMCID: PMC6199729, DOI: 10.1186/s13063-018-2957-0.Peer-Reviewed Original ResearchConceptsRetrospective cohort studyPublication biasNeuropsychiatric indicationsCohort studyClinical trialsRelative riskEfficacy trialsFDA approvalPositive trialsFisher's exact testRecent FDA approvalDrug Administration Amendments ActClinical trial publicationsTRIAL REGISTRATIONMAIN OUTCOMEProportion of trialsNeuropsychiatric drugsNew drug approvalsTrial publicationsExact testMedical interventionsTrialsDrug approvalNew drugsDrugs
2014
Prostate cancer early detection, version 1.2014. Featured updates to the NCCN Guidelines.
Carroll P, Parsons J, Andriole G, Bahnson R, Barocas D, Catalona W, Dahl D, Davis J, Epstein J, Etzioni R, Giri V, Hemstreet G, Kawachi M, Lange P, Loughlin K, Lowrance W, Maroni P, Mohler J, Morgan T, Nadler R, Poch M, Scales C, Shanefelt T, Vickers A, Wake R, Shead D, Ho M. Prostate cancer early detection, version 1.2014. Featured updates to the NCCN Guidelines. Journal Of The National Comprehensive Cancer Network 2014, 12: 1211-9; quiz 1219. PMID: 25190691, DOI: 10.6004/jnccn.2014.0120.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsProstate cancer early detectionCancer early detectionNCCN guidelinesProstate cancerEarly detectionNCCN Guidelines InsightsNotable recent updatesProstate Health IndexEarly Detection ProgramRecent FDA approvalMultiple risk variablesBiopsy decisionsFDA approvalDetection programRisk variablesCancerHealth indexRecent updatesMenGuidelinesBiopsy
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