A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Lingshan Wang; Kimberly Maxfield; Daphne Guinn; Rajanikanth Madabushi; Issam Zineh; Robert N. Schuck

doi:10.1002/cpt.2068

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.2068 ◽

2020 ◽

Vol 109 (1) ◽

pp. 123-130

Author(s):

Lingshan Wang ◽

Kimberly Maxfield ◽

Daphne Guinn ◽

Rajanikanth Madabushi ◽

Issam Zineh ◽

...

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Development Programs ◽

Systematic Assessment

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Role of the US Food and Drug Administration in Cancer Drug Development

Principles of Anticancer Drug Development ◽

10.1007/978-1-4419-7358-0_12 ◽

2010 ◽

pp. 305-332

Author(s):

Ann T. Farrell ◽

Ramzi N. Dagher ◽

Richard Pazdur

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Cancer Drug ◽

The Us

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Recent US Food and Drug Administration Efforts to Integrate the Patient's Perspective in Drug Development and Decision Making

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1290 ◽

2019 ◽

Vol 105 (4) ◽

pp. 789-791 ◽

Cited By ~ 1

Author(s):

Theresa Mullin ◽

Pujita Vaidya ◽

Meghana Chalasani

Keyword(s):

Decision Making ◽

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Patient’S Perspective

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When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2009.190 ◽

2009 ◽

Vol 86 (5) ◽

pp. 475-479 ◽

Cited By ~ 73

Author(s):

S-M Huang ◽

R Temple ◽

S Xiao ◽

L Zhang ◽

L J Lesko

Keyword(s):

Renal Impairment ◽

Drug Development ◽

Drug Administration ◽

Food And Drug Administration

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The Role of Population Pharmacokinetics in Drug Development in Light of the Food and Drug Administration??s ???Guidance for Industry: Population Pharmacokinetics???

Clinical Pharmacokinetics ◽

10.2165/00003088-200039060-00001 ◽

2000 ◽

Vol 39 (6) ◽

pp. 385-395 ◽

Cited By ~ 43

Author(s):

Paul J. Williams ◽

Ene I. Ette

Keyword(s):

Drug Development ◽

Population Pharmacokinetics ◽

Drug Administration ◽

Food And Drug Administration

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An Overview of How the Food and Drug Administration Regulates New Drug Development in the United States

Drug Information Journal ◽

10.1177/009286159603000318 ◽

1996 ◽

Vol 30 (3) ◽

pp. 745-751 ◽

Cited By ~ 1

Author(s):

Stan Stringer

Keyword(s):

United States ◽

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

New Drug ◽

New Drug Development

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Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies

Journal of Pharmacy And Bioallied Sciences ◽

10.4103/0975-7406.72130 ◽

2010 ◽

Vol 2 (4) ◽

pp. 307 ◽

Cited By ~ 29

Author(s):

Rajiv Mahajan ◽

Kapil Gupta

Keyword(s):

Drug Development ◽

Drug Administration ◽

Critical Path ◽

Food And Drug Administration ◽

Development Paradigm

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Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview

Expert Opinion on Medical Diagnostics ◽

10.1517/17530059.2011.588947 ◽

2011 ◽

Vol 5 (5) ◽

pp. 369-374 ◽

Cited By ~ 19

Author(s):

Janet Woodcock ◽

ShaAvhree Buckman ◽

Federico Goodsaid ◽

Marc K Walton ◽

Issam Zineh

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration

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The US Food and Drug Administration, neurologists, and drug development and regulation

Neurology Clinical Practice ◽

10.1212/cpj.0000000000000153 ◽

2015 ◽

Vol 5 (4) ◽

pp. 338-343

Author(s):

Gerald J. Dal Pan

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

The Us

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The Role of the Food and Drug Administration in Pharmacoeconomic Evaluation During the Drug Development Process

Drug Information Journal ◽

10.1177/009286150003400428 ◽

2000 ◽

Vol 34 (4) ◽

pp. 1207-1213 ◽

Cited By ~ 2

Author(s):

Jennifer Kim ◽

Carolyn Blank Morris ◽

Kevin Alan Schulman

Keyword(s):

Drug Development ◽

Drug Administration ◽

Development Process ◽

Food And Drug Administration ◽

Pharmacoeconomic Evaluation ◽

Drug Development Process

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Oncology Drug Development and Approval of Systemic Anticancer Therapy by the U.S. Food and Drug Administration

The Oncologist ◽

10.1634/theoncologist.2012-0235 ◽

2012 ◽

Vol 18 (1) ◽

pp. 104-111 ◽

Cited By ~ 22

Author(s):

Robert E. Martell ◽

David Sermer ◽

Kenneth Getz ◽

Kenneth I. Kaitin

Keyword(s):

Drug Development ◽

Drug Administration ◽

Food And Drug Administration ◽

Anticancer Therapy ◽

Oncology Drug ◽

Oncology Drug Development ◽

The U.S

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