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Reviewing the role of healthy volunteer studies in drug development

Journal of translational medicine, 2018-12, Vol.16 (1), p.336-15, Article 336

2018

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Monitoring the quality of conduct of clinical trials: a survey of current practices

Clinical trials (London, England), 2011-06, Vol.8 (3), p.342-349

2011

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Cycle Time Metrics for Multisite Clinical Trials in the United States

Therapeutic Innovation & Regulatory Science, 2013-03, Vol.47 (2), p.152-160

2013

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Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Therapeutic Innovation & Regulatory Science, 2013-03, Vol.47 (2), p.161-166

2013

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Preclinical and Clinical Pharmacodynamic Assessment of L-778,123, a Dual Inhibitor of Farnesyl:Protein Transferase and Geranylgeranyl:Protein Transferase Type-I

Molecular cancer therapeutics, 2002-07, Vol.1 (9), p.747-758

2002

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Effects of specific inhibition of cyclooxygenase-2 on sodium balance, hemodynamics, and vasoactive eicosanoids

The Journal of pharmacology and experimental therapeutics, 1999-05, Vol.289 (2), p.735

1999

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Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled trial

Obstetrics and gynecology (New York. 1953), 1999-10, Vol.94 (4), p.504-508

1999

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A Phase I Trial of the Dual Farnesyltransferase and Geranylgeranyltransferase Inhibitor L-778,123 and Radiotherapy for Locally Advanced Pancreatic Cancer

Clinical cancer research, 2004-08, Vol.10 (16), p.5447-5454

2004

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Cycle Time Metrics for Multisite Clinical Trials in the United States

Therapeutic Innovation & Regulatory Science, 2013-03, Vol.47 (2), p.152-160

2013

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A Phase I Trial of the Farnesyltransferase Inhibitor L-778,123 and Radiotherapy for Locally Advanced Lung and Head and Neck Cancer

Clinical cancer research, 2002-05, Vol.8 (5), p.1065-1072

2002

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A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: A single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model

Clinical therapeutics, 2002-10, Vol.24 (10), p.1549-1560

2002

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Breast cancer-associated antigen, DF3/MUC1, induces apoptosis of activated human T cells

Nature medicine, 1996-12, Vol.2 (12), p.1367-1370

1996

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The optimal analgesic dose of rofecoxib: Overview of six randomized controlled trials

The Journal of the American Dental Association (1939), 2000-12, Vol.131 (12), p.1729-1737

2000

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Research methods in educational leadership & management: 3. ed

2012

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Mat-8, a Novel Phospholemman-like Protein Expressed in Human Breast Tumors, Induces a Chloride Conductance in Xenopus Oocytes (∗)

The Journal of biological chemistry, 1995-02, Vol.270 (5), p.2176-2182

1995

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Clinical Trials: Rethinking How We Ensure Quality

Drug information journal, 2012-11, Vol.46 (6), p.657-660

2012

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The ethics of non-inferiority trials

The Lancet (British edition), 2008-03, Vol.371 (9616), p.895-895

Soliman, Elsayed Z

2008

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Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: A randomized, controlled trial

Clinical therapeutics, 1999-06, Vol.21 (6), p.943-953

1999

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neu and ras initiate murine mammary tumors that share genetic markers generally absent in c-myc and int-2-initiated tumors

Oncogene, 1994-12, Vol.9 (12), p.3417-3426

1994

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Meeting the obligation to communicate clinical trial results to study volunteers

Expert review of clinical pharmacology, 2012-03, Vol.5 (2), p.149-156

2012

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The ethics of non-inferiority trials

The Lancet (British edition), 2008-03, Vol.371 (9616), p.895-896

2008

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The ethics of non-inferiority trials/Authors' reply

The Lancet (British edition), 2008-03, Vol.371 (9616), p.895

2008

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Providing Results to Volunteers

Applied clinical trials, 2010-10, Vol.19 (10), p.52

2010

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Providing results to volunteers: evaluating a new pilot program that provides clinical trial outcome summaries to subjects

Applied clinical trials, 2010-10, Vol.19 (10), p.52

2010

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Targeting HER‐2/neu for active‐specific immunotherapy in a mouse model of spontaneous breast cancer

International journal of cancer, 1999-10, Vol.83 (3), p.393-400

1999

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Reviewing the role of healthy volunteer studies in drug development

Monitoring the quality of conduct of clinical trials: a survey of current practices

Cycle Time Metrics for Multisite Clinical Trials in the United States

Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Preclinical and Clinical Pharmacodynamic Assessment of L-778,123, a Dual Inhibitor of Farnesyl:Protein Transferase and Geranylgeranyl:Protein Transferase Type-I

Effects of specific inhibition of cyclooxygenase-2 on sodium balance, hemodynamics, and vasoactive eicosanoids

Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled trial

A Phase I Trial of the Dual Farnesyltransferase and Geranylgeranyltransferase Inhibitor L-778,123 and Radiotherapy for Locally Advanced Pancreatic Cancer

Cycle Time Metrics for Multisite Clinical Trials in the United States

A Phase I Trial of the Farnesyltransferase Inhibitor L-778,123 and Radiotherapy for Locally Advanced Lung and Head and Neck Cancer

A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: A single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model

Breast cancer-associated antigen, DF3/MUC1, induces apoptosis of activated human T cells

The optimal analgesic dose of rofecoxib: Overview of six randomized controlled trials

Research methods in educational leadership & management: 3. ed

Mat-8, a Novel Phospholemman-like Protein Expressed in Human Breast Tumors, Induces a Chloride Conductance in Xenopus Oocytes (∗)

Clinical Trials: Rethinking How We Ensure Quality

The ethics of non-inferiority trials

Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: A randomized, controlled trial

neu and ras initiate murine mammary tumors that share genetic markers generally absent in c-myc and int-2-initiated tumors

Meeting the obligation to communicate clinical trial results to study volunteers

The ethics of non-inferiority trials

The ethics of non-inferiority trials/Authors' reply

Providing Results to Volunteers

Providing results to volunteers: evaluating a new pilot program that provides clinical trial outcome summaries to subjects

Targeting HER‐2/neu for active‐specific immunotherapy in a mouse model of spontaneous breast cancer

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