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Research article

First published 2017-1

Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration,2010-2015

Kyu Chan Kwon, Chulung Lee

Therapeutic Innovation & Regulatory Science

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Research article

First published 1991-9

CFC Replacements: Safety Testing,Approval for Use in Metered Dose Inhalers

P. Graepel, D.J. Alexander

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Research article

First published 2019

Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in Japan

Chikara Kikuchi, Mifuyu Ohno, Takafumi Izumo [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1992-4

Pitfalls in the Drug Approval Process: Dose-Effect,Experimental Design,and Risk-Benefit Issues

Loren L. Miller

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-11

Comparison of Drug Use Between Clinical Practice and Regulatory Approval

Nanae Tanemura, Yoshiaki Uyama, Kengo Nagashima [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-3

Sample Size Calculations for Combination Drugs of 2 Monotherapies With a Single Approved Dose Level

Seung-Ho Kang, Juhee Park

Therapeutic Innovation & Regulatory Science

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Article commentary

First published 2024-1

Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies

Brian L. Erstad, Lisa E. Davis

Annals of Pharmacotherapy

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Research article

First published 2014-2

Resolution of sleepiness and fatigue: A comparison of bupropion and selective serotonin reuptake inhibitors in subjects with major depressive disorder achieving remission at doses approved in the European Union

James A Cooper, Vivian L Tucker, George I Papakostas

Journal of Psychopharmacology

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Research article

First published 2014-9

Decimal Commas Are a Problem;Actiq Is Not for Sore Throats;Dosing Error with Tasigna;Repackaging of Imbruvica Is Approved

Michael R. Cohen, Judy L. Smetzer

Hospital Pharmacy

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Research article

First published 2025-5

Deutetrabenazine treatment outcomes with doses above U.S. Food and Drug Administration maximum approved doses in Huntington's disease chorea: A dual-site analysis

Kayla Dodson, Sabrina Livezey, Brittany Denson [...]

Journal of Huntington's Disease

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