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  1. Article

    Open Access

    Safety, Tolerability, Pharmacokinetics and Initial Pharmacodynamics of a Subcommissural Organ-Spondin-Derived Peptide: A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose First-in-Human Study

    This randomized, double-blind, placebo-controlled study in healthy volunteers assessed the safety, tolerability, and pharmacokinetics of single ascending doses of intravenously administered NX210—a linear pept...

    Valérie Bourdès, Peter Dogterom, André Aleman, Pierre Parmantier… in Neurology and Therapy (2022)

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  2. No Access

    Article

    Comparison of the Pharmacokinetic Profiles of Trientine Tetrahydrochloride and Trientine Dihydrochloride in Healthy Subjects

    Wilson disease (WD) is an autosomal recessive inherited disorder of copper metabolism. Chelation of excessive copper is recommended but data on the pharmacokinetics of trientine are limited. The aim of this st...

    Karl Heinz Weiss, Catherine Thompson… in European Journal of Drug Metabolism and Ph… (2021)

  3. No Access

    Article

    Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

    As part of the overall product development and manufacturing strategy, pharmaceutical companies routinely change formulation and manufacturing site. Depending on the type and level of change and the BCS class ...

    Amitava Mitra, Filippos Kesisoglou, Peter Dogterom in AAPS PharmSciTech (2015)

  4. No Access

    Article

    The effect of food on the high clearance drug asenapine after sublingual administration to healthy male volunteers

    To determine the effects of food on the pharmacokinetics of sublingual asenapine.

    Peter Dogterom, Rik de Greef… in European Journal of Clinical Pharmacology (2015)

  5. Article

    Open Access

    Maximum Tolerated Dose Evaluation of the AMPA Modulator Org 26576 in Healthy Volunteers and Depressed Patients

    A key challenge to dose selection in early central nervous system (CNS) clinical drug development is that patient tolerability profiles often differ from those of healthy volunteers (HVs), yet HVs are the moda...

    Dr. Kari R. Nations, Roberta Bursi, Peter Dogterom, Larry Ereshefsky… in Drugs in R&D (2012)

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  6. No Access

    Article

    Translational PK–PD modelling of molecular target modulation for the AMPA receptor positive allosteric modulator Org 26576

    The α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor potentiator Org 26576 represents an interesting pharmacological tool to evaluate the utility of glutamatergic enhancement towards the tr...

    Roberta Bursi, Gul Erdemli, Robert Campbell, Matthew M. Hutmacher… in Psychopharmacology (2011)

  7. No Access

    Article

    Asenapine Pharmacokinetics in Hepatic and Renal Impairment

    Background and Objective: The effects of hepatic or renal impairment on the pharmacokinetics of atypical antipsychotics are not well understood. Drug exposure may increase in patients with hepati...

    Dr Pierre Peeters, Howard Bockbrader, Edwin Spaans… in Clinical Pharmacokinetics (2011)