Simultaneous Quantification of Dexamethasone and 6β-hydroxydexamethasone in Rabbit Plasma, Aqueous and Vitreous Humor, and Retina by UHPLC–MS/MS

Gu, Jinlou; Wang, Jiang; Krishna, Ashok; Xu, Lin; Stewart, Sharron; Wang, Yan; Faustino, Patrick J.; Shakleya, Diaá M.

doi:10.4155/bio-2021-0088

Cited by 5 publications

(1 citation statement)

References 35 publications

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“…Unfortunately, no generic implants are available on the market largely due to the challenges associated with measuring drug concentration within the eye to establish bioequivalence. DARS conducted a non-clinical in vivo study to measure and correlate intraocular and systemic dexamethasone concentrations after intravitreal implantation ( 65 ). This research will inform whether systemic dexamethasone exposure might serve as a surrogate for intra-ocular exposure in assessing the bioequivalence of generic dexamethasone implants.…”

Section: Facilitating Biosimilar and Complex Generic Developmentmentioning

confidence: 99%

New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

et al. 2023

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The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse backgrounds to collaborate in tackling some of the most complex challenges facing FDA. This includes (but is not limited to) assessing the systemic absorption of sunscreens, evaluating whether certain drugs can convert to carcinogens in people, studying drug interactions with opioids, optimizing opioid antagonist dosing in community settings, removing barriers to biosimilar and generic drug development, and advancing therapeutic development for rare diseases. FDA tasks DARS with wide ranging issues that encompass regulatory science; DARS, in turn, helps the Agency solve these challenges. The impact of DARS research is felt by patients, the pharmaceutical industry, and fellow regulators. This article reviews applied research projects and initiatives led by DARS and conducts a deeper dive into select examples illustrating the impactful work of the Division.

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Section: Facilitating Biosimilar and Complex Generic Developmentmentioning

confidence: 99%