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Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - a practical guide

Expert opinion on drug delivery, 2017-05, Vol.14 (5), p.657-672

2017

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Single‐Dose, Randomized, Double‐Blind, Placebo‐Controlled Study of ACE‐011 (ActRIIA‐IgG1) in Postmenopausal Women

Journal of bone and mineral research, 2009-04, Vol.24 (4), p.744-752

2009

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Pharmacokinetics and Pharmacodynamics of Anacetrapib Following Single Doses in Healthy, Young Japanese and White Male Subjects

Journal of clinical pharmacology, 2018-02, Vol.58 (2), p.254-262

2018

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Safety and Pharmacokinetics of the Anti-Orthopoxvirus Compound ST-246 following a Single Daily Oral Dose for 14 Days in Human Volunteers

Antimicrobial Agents and Chemotherapy, 2012-09, Vol.56 (9), p.4900-4905

2012

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First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain

Pain reports, 2018-05, Vol.3 (3), p.e653-e653

2018

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Evaluation of pharmacokinetic parameters and dipeptidyl peptidase‐4 inhibition following single doses of sitagliptin in healthy, young Japanese males

British journal of clinical pharmacology, 2011-03, Vol.71 (3), p.429-436

2011

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Use of Accelerator Mass Spectrometry to Measure the Pharmacokinetics and Peripheral Blood Mononuclear Cell Concentrations of Zidovudine

Journal of pharmaceutical sciences, 2008-07, Vol.97 (7), p.2833-2843

2008

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Contribution of a Heating Element to Topical Anesthesia Patch Efficacy Prior to Vascular Access: Results From Two Randomized, Double-Blind Studies

Journal of pain and symptom management, 2010-10, Vol.40 (4), p.510-519

2010

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Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults

Pediatrics international, 2008-06, Vol.50 (3), p.295-299

2008

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Safety and Pharmacokinetics of Single Doses of (+)-Calanolide A, a Novel, Naturally Occurring Nonnucleoside Reverse Transcriptase Inhibitor, in Healthy, Human Immunodeficiency Virus-Negative Human Subjects

Antimicrobial Agents and Chemotherapy, 2001-05, Vol.45 (5), p.1379-1386

2001

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BPS804 Anti‐Sclerostin Antibody in Adults With Moderate Osteogenesis Imperfecta: Results of a Randomized Phase 2a Trial

Journal of bone and mineral research, 2017-07, Vol.32 (7), p.1496-1504

2017

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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Pharmacokinetics (PK), Pharmacodynamics (PD), and Tolerability of LP352 in Healthy Subjects (P14-8.002)

Neurology, 2022-05, Vol.98 (18_supplement)

2022

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Single Ascending Dose Pharmacokinetics (PK), Pharmacodynamics (PD), and Tolerability of LP352 in Healthy Subjects (P14-8.001)

Neurology, 2022-05, Vol.98 (18_supplement)

2022

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An Exploratory Trial of an Investigational RNA Therapeutic, IONIS-FB-LRx, for Treatment of IgA Nephropathy: New Interim Results: SA-PO926

Journal of the American Society of Nephrology, 2023-11, Vol.34 (11S), p.988-988

2023

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An Exploratory Trial of an Investigational RNA Therapeutic, IONIS-FB-LRx, for Treatment of IgA Nephropathy: SA-PO714

Journal of the American Society of Nephrology, 2022-11, Vol.33 (11S), p.800-800

2022

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Anticholinesterase and pharmacokinetic profile of phenserine in healthy elderly human subjects

Current Alzheimer research, 2005-10, Vol.2 (4), p.483-492

2005

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P139 OLORINAB, A PERIPHERALLY RESTRICTED, HIGHLY SELECTIVE AGONIST OF THE CANNABINOID RECEPTOR TYPE 2 FOR THE MANAGEMENT OF VISCERAL PAIN IN INFLAMMATORY BOWEL DISEASE (IBD) – PRECLINICAL AND EARLY CLINICAL DEVELOPMENT

Gastroenterology (New York, N.Y. 1943), 2019-02, Vol.156 (3), p.S92-S93

2019

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P139 OLORINAB, A PERIPHERALLY RESTRICTED, HIGHLY SELECTIVE AGONIST OF THE CANNABINOID RECEPTOR TYPE 2 FOR THE MANAGEMENT OF VISCERAL PAIN IN INFLAMMATORY BOWEL DISEASE (IBD) – PRECLINICAL AND EARLY CLINICAL DEVELOPMENT

Inflammatory bowel diseases, 2019-02, Vol.25 (Supplement_1), p.S64-S64

2019

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Effects of Laropiprant, a Selective Prostaglandin D2 Receptor 1 Antagonist, on the Pharmacokinetics of Rosiglitazone

Cardiovascular therapeutics, 2009-12, Vol.27 (4), p.239-245

2009

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Lycopene bioavailability and metabolism in humans: an accelerator mass spectrometry study

The American journal of clinical nutrition, 2011-06, Vol.93 (6), p.1263-1273

2011

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1040 A Novel High Purity Short-Chain Galacto-Oligosaccharide (RP-G28) Improves Lactose Digestion and Symptoms of Lactose Intolerance

Gastroenterology (New York, N.Y. 1943), 2012-05, Vol.142 (5), p.S-182-S-182

2012

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Pharmacokinetics of repaglinide in subjects with renal impairment

Clinical pharmacology and therapeutics, 2000-01, Vol.67 (1), p.7-15

2000

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Multiple-Dose Pharmacokinetics of Fluvoxamine in Children and Adolescents

Journal of the American Academy of Child and Adolescent Psychiatry, 2004-12, Vol.43 (12), p.1497-1505

2004

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Effects of Laropiprant, a Selective Prostaglandin D 2 Receptor 1 Antagonist, on the Pharmacokinetics of Rosiglitazone

Cardiovascular therapeutics, 2009-12, Vol.27 (4), p.239-245

2009

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Equivalence of Liquid and Freeze-Dried Formulations of WinRho® SDF

Blood, 2005-11, Vol.106 (11), p.3988-3988

2005

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Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - a practical guide

Single‐Dose, Randomized, Double‐Blind, Placebo‐Controlled Study of ACE‐011 (ActRIIA‐IgG1) in Postmenopausal Women

Pharmacokinetics and Pharmacodynamics of Anacetrapib Following Single Doses in Healthy, Young Japanese and White Male Subjects

Safety and Pharmacokinetics of the Anti-Orthopoxvirus Compound ST-246 following a Single Daily Oral Dose for 14 Days in Human Volunteers

First-in-human randomized clinical trials of the safety and efficacy of tanezumab for treatment of chronic knee osteoarthritis pain or acute bunionectomy pain

Evaluation of pharmacokinetic parameters and dipeptidyl peptidase‐4 inhibition following single doses of sitagliptin in healthy, young Japanese males

Use of Accelerator Mass Spectrometry to Measure the Pharmacokinetics and Peripheral Blood Mononuclear Cell Concentrations of Zidovudine

Contribution of a Heating Element to Topical Anesthesia Patch Efficacy Prior to Vascular Access: Results From Two Randomized, Double-Blind Studies

Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults

Safety and Pharmacokinetics of Single Doses of (+)-Calanolide A, a Novel, Naturally Occurring Nonnucleoside Reverse Transcriptase Inhibitor, in Healthy, Human Immunodeficiency Virus-Negative Human Subjects

BPS804 Anti‐Sclerostin Antibody in Adults With Moderate Osteogenesis Imperfecta: Results of a Randomized Phase 2a Trial

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Pharmacokinetics (PK), Pharmacodynamics (PD), and Tolerability of LP352 in Healthy Subjects (P14-8.002)

Single Ascending Dose Pharmacokinetics (PK), Pharmacodynamics (PD), and Tolerability of LP352 in Healthy Subjects (P14-8.001)

An Exploratory Trial of an Investigational RNA Therapeutic, IONIS-FB-LRx, for Treatment of IgA Nephropathy: New Interim Results: SA-PO926

An Exploratory Trial of an Investigational RNA Therapeutic, IONIS-FB-LRx, for Treatment of IgA Nephropathy: SA-PO714

Anticholinesterase and pharmacokinetic profile of phenserine in healthy elderly human subjects

P139 OLORINAB, A PERIPHERALLY RESTRICTED, HIGHLY SELECTIVE AGONIST OF THE CANNABINOID RECEPTOR TYPE 2 FOR THE MANAGEMENT OF VISCERAL PAIN IN INFLAMMATORY BOWEL DISEASE (IBD) – PRECLINICAL AND EARLY CLINICAL DEVELOPMENT

P139 OLORINAB, A PERIPHERALLY RESTRICTED, HIGHLY SELECTIVE AGONIST OF THE CANNABINOID RECEPTOR TYPE 2 FOR THE MANAGEMENT OF VISCERAL PAIN IN INFLAMMATORY BOWEL DISEASE (IBD) – PRECLINICAL AND EARLY CLINICAL DEVELOPMENT

Effects of Laropiprant, a Selective Prostaglandin D2 Receptor 1 Antagonist, on the Pharmacokinetics of Rosiglitazone

Lycopene bioavailability and metabolism in humans: an accelerator mass spectrometry study

1040 A Novel High Purity Short-Chain Galacto-Oligosaccharide (RP-G28) Improves Lactose Digestion and Symptoms of Lactose Intolerance

Pharmacokinetics of repaglinide in subjects with renal impairment

Multiple-Dose Pharmacokinetics of Fluvoxamine in Children and Adolescents

Effects of Laropiprant, a Selective Prostaglandin D 2 Receptor 1 Antagonist, on the Pharmacokinetics of Rosiglitazone

Equivalence of Liquid and Freeze-Dried Formulations of WinRho® SDF

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