Search results: Sage Journals

Retricted accessResearch articleFirst published January, 2017

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

Retricted accessResearch articleFirst published September, 1991

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

P. Graepel, D.J. Alexander

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Retricted accessResearch articleFirst 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

Retricted accessResearch articleFirst published April, 1992

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

Loren L. Miller

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published November, 2016

Comparison of Drug Use Between Clinical Practice and Regulatory Approval

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

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published March, 2017

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

Seung-Ho Kang, Juhee Park

Therapeutic Innovation & Regulatory Science

Free accessArticle commentaryFirst published January, 2024

Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies

Brian L. Erstad, Lisa E. Davis

Annals of Pharmacotherapy

Retricted accessResearch articleFirst published February, 2014

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

Retricted accessResearch articleFirst published September, 2014

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

Available accessResearch articleFirst published May, 2025

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

Retricted accessResearch articleFirst published January, 2017

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

Retricted accessResearch articleFirst published September, 1991

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

P. Graepel, D.J. Alexander

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Retricted accessResearch articleFirst 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

Retricted accessResearch articleFirst published April, 1992

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

Loren L. Miller

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published November, 2016

Comparison of Drug Use Between Clinical Practice and Regulatory Approval

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

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published March, 2017

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

Seung-Ho Kang, Juhee Park

Therapeutic Innovation & Regulatory Science

Free accessArticle commentaryFirst published January, 2024

Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies

Brian L. Erstad, Lisa E. Davis

Annals of Pharmacotherapy

Retricted accessResearch articleFirst published February, 2014

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

Retricted accessResearch articleFirst published September, 2014

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

Available accessResearch articleFirst published May, 2025

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