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  1. Article

    Open Access

    Population Pharmacokinetic Modeling of Abacavir/Dolutegravir/Lamivudine to Support a Fixed-Dose Combination in Children with HIV-1

    Once-daily fixed-dose combinations (FDC) containing abacavir (ABC), dolutegravir (DTG), and lamivudine (3TC) have been approved in the US for adults and children with HIV weighing ≥ 6 kg. This analysis assesse...

    Hardik Chandasana, Sven C. van Dijkman, Rashmi Mehta… in Infectious Diseases and Therapy (2024)

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  2. Article

    Open Access

    A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

    To evaluate the effects of fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis, and the safety and tolerability of fluticasone furoate treatment in children with asthma.

    Philippe Bareille, Susan Tomkins, Varsha Imber… in Allergy, Asthma & Clinical Immunology (2020)

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  3. Article

    Open Access

    Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease

    Population pharmacokinetic methods were used to characterize the pharmacokinetics of fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) in patients with chronic obstructive pulmonary disease (C...

    Rashmi Mehta, Colm Farrell, Siobhán Hayes, Ruby Birk… in Clinical Pharmacokinetics (2020)

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  4. No Access

    Article

    Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects

    The long-acting muscarinic antagonist umeclidinium (UMEC) is approved as a once-daily monotherapy and in combination with the long-acting β2 agonist vilanterol (VI) for chronic obstructive pulmonary disease. The ...

    Rashmi Mehta, Michelle Green, Bela Patel… in Journal of Pharmacokinetics and Pharmacody… (2016)

  5. No Access

    Article

    Comparison of the Pharmacokinetics of Salmeterol and Fluticasone Propionate 50/100 µg Delivered in Combination as a Dry Powder Via a Capsule-Based Inhaler and a Multi-Dose Inhaler

    The Rotacaps®/Rotahaler® system is a single unit dose inhaler being developed to deliver inhaled salmeterol/fluticasone propionate combination (SFC) as an alternative treatment option to the metered dose inhaler ...

    Rashmi Mehta, Kylie Riddell, Ashutosh Gupta… in Clinical Drug Investigation (2015)

  6. No Access

    Article

    Population Pharmacokinetics of Inhaled Umeclidinium and Vilanterol in Patients with Chronic Obstructive Pulmonary Disease

    A fixed-dose combination of the bronchodilators umeclidinium and vilanterol is in development for the long-term, once-daily treatment of chronic obstructive pulmonary disease (COPD). We characterized the pharm...

    Navin Goyal, Misba Beerahee, Chris Kalberg, Alison Church… in Clinical Pharmacokinetics (2014)

  7. Article

    Open Access

    Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study

    Umeclidinium bromide (UMEC) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease (COPD).

    Alison Church, Misba Beerahee, Jean Brooks, Rashmi Mehta… in BMC Pulmonary Medicine (2014)

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  8. No Access

    Article

    Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Inhaled Once-Daily Umeclidinium in Healthy Adults Deficient in CYP2D6 Activity: A Double-Blind, Randomized Clinical Trial

    Umeclidinium is a new, long-acting, muscarinic receptor antagonist currently in development for the treatment of chronic obstructive pulmonary disease (COPD). In vitro cell culture data suggest that up to 99 %...

    Anthony Cahn, Rashmi Mehta, Andrew Preece, James Blowers… in Clinical Drug Investigation (2013)

  9. No Access

    Article

    Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Inhaled Doses of Umeclidinium in Healthy Subjects: Two Randomized Studies

    Chronic obstructive pulmonary disease (COPD) has a significant negative impact on quality of life and increases the risk of premature death. Umeclidinium is a long-acting muscarinic receptor antagonist in deve...

    Anthony Cahn, Ruth Tal-Singer, Isabelle J. Pouliquen… in Clinical Drug Investigation (2013)