Results 71 to 80 of about 9,364 (186)
Journal of the International AIDS Society, Volume 29, Issue S1, June 2026.ABSTRACT Introduction Dolutegravir (DTG) is a key antiretroviral (ARV) drug for children living with HIV, but no specific formulation is available for neonates (<28 days old). One of the DTG formulations evaluated in the PETITE‐DTG trial was a novel 5 mg oral DTG dispersible film (DTG‐Film).
Lario Viljoen +9 more
wiley +1 more source
Bioequivalence studies for levothyroxine [PDF]
The AAPS Journal, 2005 The Food and Drug Administration (FDA) Guidance for Bioavailability and Bioequivalence Studies for Levothyroxine has been challenged by companies that manufacture brand-name products. Their contention is that the current guidance does not adequately address the endogenous background levels of the drug, and that the ratios of the PK parameters, a basis ...
openaire +2 more sources
Frontiers in PharmacologyPurposeThe aim of this study was to evaluate the bioequivalence of two formulations of rupatadine (10-mg tablets) under fasting and fed conditions in healthy Chinese subjects.MethodsA total of 72 subjects were randomly assigned to the fasting cohort (n =
Sisi Lin +10 more
doaj +1 more source
A Generative AI Framework for Pharmacokinetic Clinical Study Report Authoring
Clinical and Translational Science, Volume 19, Issue 6, June 2026.ABSTRACT Clinical Study Reports (CSRs) constitute the final consolidation of findings from clinical studies and routinely include Pharmacokinetic (PK) results. To assist with PK results authoring, we developed a generative Artificial Intelligence (AI) based method that employs a hierarchical, chained large language model (LLM) framework with in‐context
John Samuelsson +9 more
wiley +1 more source
PharmaceuticalsBackground: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan +6 more
doaj +1 more source
Frontiers in PharmacologyMost of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence.
Nedaa Alomari, Waleed Alhussaini
doaj +1 more source
Planning and evaluation of bioequivalence studies of rosuvastatin drug products
Регуляторные исследования и экспертиза лекарственных средств, 2018 The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation.
D. P. Romodanovsky, D. V. Goryachev
doaj
PharmaceuticsAs the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient’s needs.
Olha Shuklinova +7 more
doaj +1 more source
Highly variable medicines - specific aspects of bioequivalence studies
Регуляторные исследования и экспертиза лекарственных средств, 2018 At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic ...
D. P. Romodanovsky +6 more
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