Cargando…

Dose Finding in the Clinical Development of 60 US Food and Drug Administration–Approved Drugs Compared With Learning vs. Confirming Recommendations

This review characterizes clinical development that supported the label dose in 60 drug indications recently approved by the US Food and Drug Administration. With Lewis B. Sheiner's Learning vs. Confirming clinical drug development paradigm as a reference point, the clinical development paths,...

Descripción completa

Detalles Bibliográficos
Autores principales:	Lyauk, Yassine Kamal, Jonker, Daniël Martijn, Lund, Trine Meldgaard
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742935/ https://www.ncbi.nlm.nih.gov/pubmed/31254374 http://dx.doi.org/10.1111/cts.12641

Ejemplares similares

Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
por: Lyauk, Yassine Kamal, et al.
Publicado: (2020)

Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
por: Lyauk, Yassine Kamal, et al.
Publicado: (2020)

Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
por: Lyauk, Yassine Kamal, et al.
Publicado: (2021)

Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
por: Parikh, Ravi B., et al.
Publicado: (2023)

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
por: Jiao, Kuo, et al.
Publicado: (2019)

Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration
por: Feldman, Daniel, et al.
Publicado: (2022)

Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
por: Yang, Derek Z., et al.
Publicado: (2021)

Review of Evidence Supporting 2022 US Food and Drug Administration Drug Approvals
por: Kaplan, Robert M., et al.
Publicado: (2023)

Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
por: Skydel, Joshua J., et al.
Publicado: (2022)

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020
por: Kayki-Mutlu, Gizem, et al.
Publicado: (2021)

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021
por: Kayki-Mutlu, Gizem, et al.
Publicado: (2022)

Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020
por: Mitra-Majumdar, Mayookha, et al.
Publicado: (2022)

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022
por: Kayki-Mutlu, Gizem, et al.
Publicado: (2023)

Time for the US food and drug administration approval of condoms for anal intercourse
por: Nguyen, Brian T., et al.
Publicado: (2019)

Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals
por: Lammers, Austin, et al.
Publicado: (2017)

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
por: Cherla, Avi, et al.
Publicado: (2021)

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
por: Sachs, Rachel E., et al.
Publicado: (2021)

Correction to: A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021
por: Kayki-Mutlu, Gizem, et al.
Publicado: (2022)

Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021
por: Gupta, Ravi, et al.
Publicado: (2022)

Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020
por: Miljković, Miloš D., et al.
Publicado: (2022)

The U.S. Food and Drug Administration: Drug Information Resource for Formulary Recommendations
por: Marchand, Heidi C., et al.
Publicado: (2012)

U.S. Food and Drug Administration: Review for the Emergency Physician of Approval Process and Limitations
por: Zuabi, Nadia, et al.
Publicado: (2016)

Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
por: Liang, Fei, et al.
Publicado: (2020)

Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration
por: Jarosławski, Szymon, et al.
Publicado: (2018)

In Vitro‐to‐In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
por: Yu, Jingjing, et al.
Publicado: (2020)

Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
por: Hutchinson, Nora, et al.
Publicado: (2021)

Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action
por: Olivier, Timothée, et al.
Publicado: (2021)

US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018
por: Omae, Kenji, et al.
Publicado: (2022)

The US Food and Drug Administration's tentative approval process and the global fight against HIV
por: Chahal, Harinder Singh, et al.
Publicado: (2017)

Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
por: Moneer, Osman, et al.
Publicado: (2021)

Why is AAV FVIII gene therapy not approved by the US Food and Drug Administration yet?
por: Arruda, Valder R.
Publicado: (2021)

Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
por: Wallach, Joshua D., et al.
Publicado: (2021)

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
por: Wallach, Joshua D., et al.
Publicado: (2019)

US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera M., et al.
Publicado: (2023)

Approval of Raxibacumab for the Treatment of Inhalation Anthrax Under the US Food and Drug Administration “Animal Rule”
por: Tsai, Chia-Wei, et al.
Publicado: (2015)

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
por: Egilman, Alexander, et al.
Publicado: (2021)

Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
por: Modi, Natansh D., et al.
Publicado: (2022)

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera, et al.
Publicado: (2021)

Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs
por: Shahid, Izza, et al.
Publicado: (2022)

Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
por: Schein, Yvette, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_03pt8b8pb03ucod437gc26ifa7