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Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial

Drug discovery today, 2020-11, Vol.25 (11), p.1910-1918

2020

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Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers

Anesthesiology (Philadelphia), 2017-04, Vol.126 (4), p.697-707

2017

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A literature review on the pharmacological sensitivity of human evoked hyperalgesia pain models

British journal of clinical pharmacology, 2016-10, Vol.82 (4), p.903-922

2016

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Analgesic potential of PF-06372865, an α2/α3/α5 subtype-selective GABAA partial agonist, in humans

British journal of anaesthesia : BJA, 2019-08, Vol.123 (2), p.e194-e203

2019

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Pediatric oncology drug development and dosage optimization

Frontiers in oncology, 2024-01, Vol.13, p.1235947-1235947

2024

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Pharmacokinetics and pharmacodynamics of intrathecally administered Xen2174, a synthetic conopeptide with norepinephrine reuptake inhibitor and analgesic properties

British journal of clinical pharmacology, 2017-04, Vol.83 (4), p.751-763

2017

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The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid Leukemia

The oncologist (Dayton, Ohio), 2019-05, Vol.24 (5), p.e171-e179

2019

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A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applications

Regulatory toxicology and pharmacology, 2020-12, Vol.118, p.104804, Article 104804

2020

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Demonstration of an anti‐hyperalgesic effect of a novel pan‐Trk inhibitor PF‐06273340 in a battery of human evoked pain models

British journal of clinical pharmacology, 2018-02, Vol.84 (2), p.301-309

2018

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Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019

European journal of pharmaceutics and biopharmaceutics, 2021-07, Vol.164, p.66-74

2021

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Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs

European journal of pain, 2019-07, Vol.23 (6), p.1129-1140

2019

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The use of a battery of pain models to detect analgesic properties of compounds: a two‐part four‐way crossover study

British journal of clinical pharmacology, 2017-05, Vol.83 (5), p.976-990

2017

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Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery

Journal of visualized experiments, 2016-04 (110)

2016

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Hyperalgesia in Opioid-Managed Chronic Pain and Opioid-Dependent Patients

The journal of pain, 2009-03, Vol.10 (3), p.316-322

2009

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Effects of a single, oral 60 mg caffeine dose on attention in healthy adult subjects

Journal of psychopharmacology (Oxford), 2017-02, Vol.31 (2), p.222-232

2017

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Responsiveness of electrical nociceptive detection thresholds to capsaicin (8 %)-induced changes in nociceptive processing

Experimental brain research, 2016-09, Vol.234 (9), p.2505-2514

2016

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Model‐based exposure‐response analysis to quantify age related differences in the response to scopolamine in healthy subjects

British journal of clinical pharmacology, 2016-10, Vol.82 (4), p.1011-1021

2016

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Pharmacokinetics and pharmacodynamics of multiple doses of BG00010, a neurotrophic factor with anti‐hyperalgesic effects, in patients with sciatica

British journal of clinical pharmacology, 2016-07, Vol.82 (1), p.108-117

2016

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Application of exposure bracketing to streamline the development of contraceptive products

Contraception: X, 2022-01, Vol.4, p.100072, Article 100072

2022

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Lack of Detection of the Analgesic Properties of PF-05089771, a Selective Na v 1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects

Clinical and translational science, 2020-03, Vol.13 (2), p.318-324

2020

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Lack of Detection of the Analgesic Properties of PF‐05089771, a Selective Nav1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects

Clinical and translational science, 2020-03, Vol.13 (2), p.318-324

2020

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Commentary on the MID3 Good Practices Paper

CPT: pharmacometrics and systems pharmacology, 2017-07, Vol.6 (7), p.416-417

2017

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Pharmacokinetic and pharmacodynamic interactions between almorexant, a dual orexin receptor antagonist, and desipramine

European neuropsychopharmacology, 2014-08, Vol.24 (8), p.1257-1268

2014

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Dual orexin receptor antagonism by almorexant does not potentiate impairing effects of alcohol in humans

European neuropsychopharmacology, 2013-02, Vol.23 (2), p.107-117

2013

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Model of methadone-induced hyperalgesia in rats and effect of memantine

European journal of pharmacology, 2010-01, Vol.626 (2), p.229-233

2010

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Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial

Respiratory Effects of the Nociceptin/Orphanin FQ Peptide and Opioid Receptor Agonist, Cebranopadol, in Healthy Human Volunteers

A literature review on the pharmacological sensitivity of human evoked hyperalgesia pain models

Analgesic potential of PF-06372865, an α2/α3/α5 subtype-selective GABAA partial agonist, in humans

Pediatric oncology drug development and dosage optimization

Pharmacokinetics and pharmacodynamics of intrathecally administered Xen2174, a synthetic conopeptide with norepinephrine reuptake inhibitor and analgesic properties

The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid Leukemia

A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applications

Demonstration of an anti‐hyperalgesic effect of a novel pan‐Trk inhibitor PF‐06273340 in a battery of human evoked pain models

Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019

Reproducibility of a battery of human evoked pain models to detect pharmacological effects of analgesic drugs

The use of a battery of pain models to detect analgesic properties of compounds: a two‐part four‐way crossover study

Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery

Hyperalgesia in Opioid-Managed Chronic Pain and Opioid-Dependent Patients

Effects of a single, oral 60 mg caffeine dose on attention in healthy adult subjects

Responsiveness of electrical nociceptive detection thresholds to capsaicin (8 %)-induced changes in nociceptive processing

Model‐based exposure‐response analysis to quantify age related differences in the response to scopolamine in healthy subjects

Pharmacokinetics and pharmacodynamics of multiple doses of BG00010, a neurotrophic factor with anti‐hyperalgesic effects, in patients with sciatica

Application of exposure bracketing to streamline the development of contraceptive products

Lack of Detection of the Analgesic Properties of PF-05089771, a Selective Na v 1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects

Lack of Detection of the Analgesic Properties of PF‐05089771, a Selective Nav1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects

Commentary on the MID3 Good Practices Paper

Pharmacokinetic and pharmacodynamic interactions between almorexant, a dual orexin receptor antagonist, and desipramine

Dual orexin receptor antagonism by almorexant does not potentiate impairing effects of alcohol in humans

Model of methadone-induced hyperalgesia in rats and effect of memantine

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