Publications by authors named "Markham Luke"

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Improved Dual-Modality Bioequivalence Evaluation of Topical Formulations Within Human Skin Using Stimulated Raman Scattering Microscopy.
Dandan Tu, Nick-Sidney Lemberger, Kristin Wallmeier, Jackson Riseman, Benjamin A Kuzma, Markham C Luke

Pharmaceutics· September 2025

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Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations.
Mark Donnelly, Lanyan Fang, Rajanikanth Madabushi, Hao Zhu, Markham Luke

Clin Pharmacol Ther· January 2025

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Quantitative volumetric photoacoustic assessment of vasoconstriction by topical corticosteroid application in mice skin.
Donggyu Kim, Joongho Ahn, Donghyun Kim, Jin Young Kim, Seungah Yoo, Markham C Luke

Photoacoustics· December 2024

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Locally acting dermatology drug products: Pharmaco-analytic considerations for bioequivalence.
Markham C Luke

Eur J Pharm Sci· August 2024

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Determining topical product bioequivalence with stimulated Raman scattering microscopy.
Fotis Iliopoulos, Dandan Tu, Isaac J Pence, Xiaolei Li, Priyanka Ghosh, Markham C Luke

J Control Release· March 2024

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Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease.
Andrew Clerman, Markham Luke

Ann Intern Med· January 2024

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Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays.
Elham Amini, Simon M Berger, Uta Schilling, Yuanyuan Jiao, Mong-Jen Chen, Markham C Luke

Mol Pharm· November 2023

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Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs.
Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yan Wang, Markham Luke

Pharmaceutics· September 2023

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Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
Jieon Lee, Kairui Feng, Denise S Conti, Ross Walenga, Michael Wientjes, Markham C Luke

Clin Pharmacol Ther· November 2022

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Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.
Bryan Newman, Andrew Babiskin, Elizabeth Bielski, Susan Boc, Sneha Dhapare, Markham C Luke

Adv Drug Deliv Rev· November 2022

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Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.
Nashwa El-Gendy, Craig M Bertha, Mohammed Abd El-Shafy, Dhaval K Gaglani, Andrew Babiskin, Markham C Luke

Adv Drug Deliv Rev· October 2022

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The History of Dermatology and Dermatologists at the US Food and Drug Administration.
Vanessa L Burrows, Markham C Luke

Dermatol Clin· July 2022

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How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?
Priyanka Ghosh, Sam G Raney, Markham C Luke

Dermatol Clin· July 2022

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Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA.
Zhong Wang, Sharon K Ahluwalia, Bryan Newman, Sneha Dhapare, Liang Zhao, Markham C Luke

Ther Innov Regul Sci· March 2022

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Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users.
Saeid Raofi, Minori Kinjo, Dajun Sun, Zhichuan Li, Heather Boyce, Markham Luke

Clin Transl Sci· September 2021

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From Pharmacology Research, to Pharmacology Regulation, and Back-as Inspired by the Teachings of Dr. Gavril Pasternak.
Markham C Luke

Cell Mol Neurobiol· July 2021

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Regulating Generic Ophthalmologic Drug Bioequivalence-Envisioning Accessibility for Patients.
Markham C Luke, Darby Kozak

J Ocul Pharmacol Ther· April 2021

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The relationship between the number of available therapeutic options and government payer (medicare part D) spending on topical drug products.
Michael C Kwa, Kyle Tegtmeyer, Leah J Welty, Sam G Raney, Markham C Luke

Arch Dermatol Res· October 2020

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A new paradigm for topical generic drug products: Impact on therapeutic access.
Sam G Raney, Markham C Luke

J Am Acad Dermatol· June 2020

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Prevalence of Skin Cancer Examination Among Users of Indoor Tanning Beds.
Kasey L Morris, Markham C Luke, Frank M Perna

JAMA Dermatol· July 2018

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Donald S. Coffey, the Brady Long Rifles, and the war on prostate cancer.
Markham C Luke

Am J Clin Exp Urol· April 2018

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Medical device regulation: what a practicing dermatologist should know.
Jiyoung M Dang, David Krause, Richard P Felten, Markham C Luke

Dermatol Ther· July 2009

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