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  • 1-10 of  159 results for ""DRUG approval""
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Academic Journal

Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation.

  • Authors : Omae K; Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, 1 Hikarigaoka, Fukushima city, Fukushima, 960-1295, Japan. .; Department of Healthcare Epidemiology, Kyoto University School of Public Health in the Graduate School of Medicine, Kyoto, Japan. .

Subjects: Clinical Trials as Topic* ; Drug Approval* ; Journalism, Medical*

  • Source: BMC cancer [BMC Cancer] 2019 Oct 24; Vol. 19 (1), pp. 998. Date of Electronic Publication: 2019 Oct 24.Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium:

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Academic Journal

True and false positive rates for different criteria of evaluating statistical evidence from clinical trials.

  • Authors : van Ravenzwaaij D; Department of Psychology, University of Groningen, Grote Kruisstraat 2/1, Heymans Building, room 169, 9712 TS, Groningen, The Netherlands. .; Ioannidis JPA

Subjects: Bayes Theorem* ; Clinical Trials as Topic* ; Data Interpretation, Statistical*

  • Source: BMC medical research methodology [BMC Med Res Methodol] 2019 Nov 27; Vol. 19 (1), pp. 218. Date of Electronic Publication: 2019 Nov 27.Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium:

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Academic Journal

Recent drug approvals for acute myeloid leukemia.

  • Authors : Lai C; Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, DC, USA. .; Doucette K

Subjects: Drug Approval*; Antineoplastic Agents/Antineoplastic Agents/Antineoplastic Agents/*pharmacology ; Leukemia, Myeloid, Acute/Leukemia, Myeloid, Acute/Leukemia, Myeloid, Acute/*drug therapy

  • Source: Journal of hematology & oncology [J Hematol Oncol] 2019 Sep 18; Vol. 12 (1), pp. 100. Date of Electronic Publication: 2019 Sep 18.Publisher: Biomed Central Country of Publication: England NLM ID: 101468937 Publication Model: Electronic Cited Medium:

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Academic Journal

Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.

  • Authors : Happel AU; Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa. .; NRF-DST CAPRISA Centre of Excellence in HIV Prevention, Cape Town, South Africa. .

Subjects: Probiotics/Probiotics/Probiotics/*therapeutic use ; Vaginosis, Bacterial/Vaginosis, Bacterial/Vaginosis, Bacterial/*microbiology ; Vaginosis, Bacterial/Vaginosis, Bacterial/Vaginosis, Bacterial/*therapy

  • Source: BMC infectious diseases [BMC Infect Dis] 2020 Jul 10; Vol. 20 (1), pp. 491. Date of Electronic Publication: 2020 Jul 10.Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium:

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Academic Journal

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials.

  • Authors : Doua YJ; Consortium for African Regulatory Expertise Development (CARED), Voorburg, The Netherlands. .; Clinical and Medical Department, Janssen Infectious Diseases and Vaccines, Crucell Holland BV, Leiden, The Netherlands. .

Subjects: Clinical Trials as Topic* ; Documentation* ; Drug Approval*

  • Source: Trials [Trials] 2019 Apr 11; Vol. 20 (1), pp. 212. Date of Electronic Publication: 2019 Apr 11.Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium:

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Editorial & Opinion

From COVID-19 research to vaccine application: why might it take 17 months not 17 years and what are the wider lessons?

  • Authors : Hanney SR; Health Economics Research Group, Brunel University London, Kingston Lane, Uxbridge, UK. .; Wooding S

Subjects: Betacoronavirus* ; Viral Vaccines*; Coronavirus Infections/Coronavirus Infections/Coronavirus Infections/*prevention & control COVID-19severe acute respiratory syndrome coronavirus 2

  • Source: Health research policy and systems [Health Res Policy Syst] 2020 Jun 08; Vol. 18 (1), pp. 61. Date of Electronic Publication: 2020 Jun 08.Publisher: BioMed Central Country of Publication: England NLM ID: 101170481 Publication Model: Electronic Cited Medium:

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Academic Journal

Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.

  • Authors : Collignon O; European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK. .; Competence Center for Methodology and Statistics, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg. .

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/legislation & jurisprudence ; Government Agencies*/Government Agencies*/Government Agencies*/legislation & jurisprudence ; Marketing of Health Services*/Marketing of Health Services*/Marketing of Health Services*/legislation & jurisprudence

  • Source: Trials [Trials] 2018 Nov 20; Vol. 19 (1), pp. 642. Date of Electronic Publication: 2018 Nov 20.Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium:

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Editorial & Opinion

Decisions in health technology assessment: should we speak with one voice?

  • Authors : Merlin T; Adelaide Health Technology Assessment (AHTA), School of Public Health, University of Adelaide, Adelaide, South Australia, 5005, Australia. .

Subjects: Cost-Benefit Analysis* ; Decision Making* ; Drug Approval*

  • Source: Health research policy and systems [Health Res Policy Syst] 2018 Nov 15; Vol. 16 (1), pp. 108. Date of Electronic Publication: 2018 Nov 15.Publisher: BioMed Central Country of Publication: England NLM ID: 101170481 Publication Model: Electronic Cited Medium:

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Academic Journal

Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.

  • Authors : Zou CX; Yale School of Medicine, New Haven, CT, USA.; Becker JE

Subjects: Drug Approval* ; Publication Bias* ; Registries*

  • Source: Trials [Trials] 2018 Oct 23; Vol. 19 (1), pp. 581. Date of Electronic Publication: 2018 Oct 23.Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium:

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Academic Journal

Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

  • Authors : Mulinari S; Department of Sociology, Faculty of Social Sciences, Lund University, Box 117, 221 00, Lund, Sweden. .; Davis C

Subjects: Antiviral Agents/Antiviral Agents/Antiviral Agents/*therapeutic use ; Drug Approval/Drug Approval/Drug Approval/*methods ; Drug Approval/Drug Approval/Drug Approval/*organization & administration

  • Source: Health research policy and systems [Health Res Policy Syst] 2017 Nov 09; Vol. 15 (1), pp. 93. Date of Electronic Publication: 2017 Nov 09.Publisher: BioMed Central Country of Publication: England NLM ID: 101170481 Publication Model: Electronic Cited Medium:

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  • 1-10 of  159 results for ""DRUG approval""