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IL‐1 receptor antagonist plus pentoxifylline and zinc for severe alcohol‐associated hepatitis

Hepatology (Baltimore, Md.), 2022-10, Vol.76 (4), p.1058-1068

2022

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Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic

Journal of clinical and translational science, 2021-02, Vol.5 (1), p.e94-e94, Article e94

2021

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Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine"

Clinical and investigative medicine, 2013-12, Vol.36 (6), p.E290-E296

2013

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Right now, in the right way: U. S. Food and Drug Administration's expanded access program and patient rights

Journal of clinical and translational science, 2018-06, Vol.2 (3), p.115-117

2018

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Longitudinal Experience With and Impressions of COVID-19-Related Clinical Research Changes

JCO oncology practice, 2022-01, Vol.18 (1), p.e98-e107

2022

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Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

Clinical and translational science, 2015-10, Vol.8 (5), p.526-532

2015

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Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments

Journal of the National Comprehensive Cancer Network, 2021-05, Vol.19 (5), p.505-512

2021

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Count me in: using a patient portal to minimize implicit bias in clinical research recruitment

Journal of the American Medical Informatics Association : JAMIA, 2019-08, Vol.26 (8-9), p.703-713

2019

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Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

Journal of investigative medicine, 2009-08, Vol.57 (6), p.688-694

Holbein, M. E. Blair

2009

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Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

Journal of investigative medicine, 2012-10, Vol.60 (7), p.987-994

2012

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Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

Journal of investigative medicine, 2014-06, Vol.62 (5), p.797-803

2014

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Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium

Journal of investigative medicine, 2014-06, Vol.62 (5), p.797

2014

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Clinical trial registration and reporting: a survey of academic organizations in the United States

BMC medicine, 2018-05, Vol.16 (1), p.60-60, Article 60

2018

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Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research

Journal of investigative medicine, 2021-06, Vol.69 (5), p.1050-1055

2021

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Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

Journal of investigative medicine, 2009-08, Vol.57 (6), p.688-694

Holbein, M. E. Blair

2009

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Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators

Journal of investigative medicine, 2012-10, Vol.60 (7), p.987-994

2012

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Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients

JAMA : the journal of the American Medical Association, 1993-01, Vol.269 (2), p.249

1993

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Recommendations from the IND/IDE Taskforce of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

Journal of investigative medicine, 2014-06, Vol.62 (5), p.797-803

2014

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Exercise-associated collapse in cyclists is unrelated to endotoxemia

Medicine and science in sports and exercise, 1995-09, Vol.27 (9), p.1238-1242

1995

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Intraventricular hemorrhage and vitamin E in the very low-birth-weight infant: evidence for efficacy of early intramuscular vitamin E administration

Pediatrics (Evanston), 1984-12, Vol.74 (6), p.1107-1112

1984

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Retrolental fibroplasia and vitamin E in the preterm infant--comparison of oral versus intramuscular:oral administration

Pediatrics (Evanston), 1984-01, Vol.73 (2), p.238-249

1984

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Cephalosporin confusion--one simple solution?

American journal of health-system pharmacy, 1991-02, Vol.48 (2), p.236-236

1991

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Vitamin E in retrolental fibroplasia

The New England journal of medicine, 1983-09, Vol.309 (11), p.669-670

1983

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Effect of acute hypoxemia on cerebral blood flow velocity control during lower body negative pressure

Physiological reports, 2018-02, Vol.6 (4), p.e13594-n/a

2018

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INTRAVENTRICULAR HEMORRHAGE (IVH) & VITAMIN E (VE) IN VERY LOW BIRTH WEIGHT INFANTS: EFFICACY OF EARLY IM ADMINISTRATION

Pediatric research, 1984-04, Vol.18, p.383-383A

1984

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IL‐1 receptor antagonist plus pentoxifylline and zinc for severe alcohol‐associated hepatitis

Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine"

Right now, in the right way: U. S. Food and Drug Administration's expanded access program and patient rights

Longitudinal Experience With and Impressions of COVID-19-Related Clinical Research Changes

Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments

Count me in: using a patient portal to minimize implicit bias in clinical research recruitment

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium

Clinical trial registration and reporting: a survey of academic organizations in the United States

Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators

Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients

Recommendations from the IND/IDE Taskforce of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

Exercise-associated collapse in cyclists is unrelated to endotoxemia

Intraventricular hemorrhage and vitamin E in the very low-birth-weight infant: evidence for efficacy of early intramuscular vitamin E administration

Retrolental fibroplasia and vitamin E in the preterm infant--comparison of oral versus intramuscular:oral administration

Cephalosporin confusion--one simple solution?

Vitamin E in retrolental fibroplasia

Effect of acute hypoxemia on cerebral blood flow velocity control during lower body negative pressure

INTRAVENTRICULAR HEMORRHAGE (IVH) & VITAMIN E (VE) IN VERY LOW BIRTH WEIGHT INFANTS: EFFICACY OF EARLY IM ADMINISTRATION

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