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Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial
Adam L. Boxer et al. · The Lancet Neurology
Open access |
26 May 2014 |
300 |
| 2 |
Drug-Drug Interaction Studies of Cardiovascular Drugs Involving P-Glycoprotein, an Efflux Transporter, on the Pharmacokinetics of Edoxaban, an Oral Factor Xa Inhibitor
Jeanne Mendell, Hamim Zahir, Nobuko Matsushima et al. · American Journal of Cardiovascular Drugs
Open access |
19 Jun 2013 |
228 |
| 3 |
Bioavailability and Safety of the Factor Xa Inhibitor Edoxaban and the Effects of Quinidine in Healthy Subjects
Nobuko Matsushima, Frank Lee, Toshiyuki Sato et al. · Clinical Pharmacology in Drug Development
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9 Sep 2013 |
154 |
| 4 |
Validation of a microdose probe drug cocktail for clinical drug interaction assessments for drug transporters and CYP3A
Thomayant Prueksaritanont, DA Tatosian, Xiaoyan Chu et al. · Clinical Pharmacology & Therapeutics
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10 Dec 2016 |
144 |
| 5 |
A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers
Grant C. O’Connell, John D. Pritchard, Chris Prue et al. · Internal and Emergency Medicine
Open access |
2 Feb 2019 |
114 |
| 6 |
A phase 1 study of ACE‐536, a regulator of erythroid differentiation, in healthy volunteers
Kenneth M. Attie, Mark J. Allison, Ty McClure et al. · American Journal of Hematology
Open access |
9 Apr 2014 |
110 |
| 7 |
Association of cardiac and vascular changes with ambient PM2.5 in diabetic individuals
Alexandra Elisabeth Schneider, Lucas Neas, Don W Graff et al. · Particle and Fibre Toxicology
Open access |
2010 |
102 |
| 8 |
First-in-human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti-CD40 monoclonal antibody
Pascal Espié, Yanling He, Phillip J. Koo et al. · American Journal of Transplantation
Open access |
24 Oct 2019 |
94 |
| 9 |
Clinical assessment of hepatic de novo lipogenesis in non-alcoholic fatty liver disease
Sabina Paglialunga, Clayton A. Dehn · Lipids in Health and Disease
Open access |
17 Sep 2016 |
93 |
| 10 |
Effect of bimagrumab on thigh muscle volume and composition in men with casting‐induced atrophy
Daniel Rooks, Didier Laurent, Jens Præstgaard et al. · Journal of Cachexia Sarcopenia and Muscle
Open access |
14 Sep 2017 |
91 |
| 11 |
Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis
Steve Lowes et al. · Bioanalysis
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Jun 2011 |
89 |
| 12 |
QT Assessment in Early Drug Development: The Long and the Short of It
Robert M. Lester, Sabina Paglialunga, Ian Johnson · International Journal of Molecular Sciences
Open access |
15 Mar 2019 |
82 |
| 13 |
Cystatin C Is a More Reliable Biomarker for Determining eGFR to Support Drug Development Studies
Sumit Kar, Sabina Paglialunga, M. Rafiqul Islam · The Journal of Clinical Pharmacology
|
18 May 2018 |
77 |
| 14 |
Pharmacokinetic Interactions Between the Hepatitis C Virus Protease Inhibitor Boceprevir and Ritonavir-Boosted HIV-1 Protease Inhibitors Atazanavir, Darunavir, and Lopinavir
Ellen G. J. Hulskotte, Hwa-ping Feng, Fengjuan Xuan et al. · Clinical Infectious Diseases
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15 Nov 2012 |
77 |
| 15 |
Pharmacokinetic (PK) drug interaction studies of cabozantinib: Effect of CYP3A inducer rifampin and inhibitor ketoconazole on cabozantinib plasma PK and effect of cabozantinib on CYP2C8 probe substrate rosiglitazone plasma PK
Linh Thuy Nguyen, Jaymes S. Holland, Dale Miles et al. · The Journal of Clinical Pharmacology
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9 Apr 2015 |
77 |
| 16 |
Measurement of cardiovascular and pulmonary function endpoints and other physiological effects following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers
Carl D. D’Ruiz, Grant C. O’Connell, Donald W. Graff et al. · Regulatory Toxicology and Pharmacology
Open access |
2 May 2017 |
75 |
| 17 |
Evaluation of the effect of food and gastric pH on the single‐dose pharmacokinetics of cabozantinib in healthy adult subjects
Linh Thuy Nguyen, Jaymes S. Holland, Richard D. Mamelok et al. · The Journal of Clinical Pharmacology
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22 Apr 2015 |
75 |
| 18 |
2013 White Paper on Recent Issues in Bioanalysis: ‘ Hybrid ’ – The Best of LBA and LCMS
Lauren F. Stevenson et al. · Bioanalysis
|
10 Oct 2013 |
75 |
| 19 |
Reductions in biomarkers of exposure (BoE) to harmful or potentially harmful constituents (HPHCs) following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers
Grant C. O’Connell, Donald W. Graff, Carl D. D’Ruiz · Toxicology Mechanisms and Methods
Open access |
12 Jul 2016 |
74 |
| 20 |
2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 3 – Lba, Biomarkers and Immunogenicity)
Lakshmi S. Amaravadi et al. · Bioanalysis
Open access |
Dec 2015 |
74 |
| 21 |
2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)
Shalini Gupta et al. · Bioanalysis
Open access |
Dec 2017 |
69 |
| 22 |
A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants
Fady I. Malik, Laura A Robertson, Danielle R. Armas et al. · JACC Basic to Translational Science
Open access |
Aug 2022 |
68 |
| 23 |
A Phase 1 Randomized, Double‐Blind, Placebo‐Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK‐1654 in Healthy Adults
Antonios O. Aliprantis, Dennis G. Wolford, Luzelena Caro et al. · Clinical Pharmacology in Drug Development
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30 Oct 2020 |
67 |
| 24 |
First‐in‐Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers
Jonathan C. Fox, Jennifer L. Hellawell, Satish Rao et al. · Clinical Pharmacology in Drug Development
Open access |
6 Jun 2019 |
67 |
| 25 |
Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes
Carl D. D’Ruiz, Donald W. Graff, Edward Robinson · BMC Public Health
Open access |
11 Jul 2016 |
67 |
| 26 |
Locally acting ACE‐083 increases muscle volume in healthy volunteers
Chad E. Glasser, Michael Gartner, Dawn M. Wilson et al. · Muscle & Nerve
Open access |
27 Feb 2018 |
64 |
| 27 |
Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability
Mitchell F. Stiles, Leanne R. Campbell, Donald W. Graff et al. · Psychopharmacology
Open access |
20 Jun 2017 |
63 |
| 28 |
Recommendations on Biomarker Bioanalytical Method Validation By Gcc
Richard Hougton et al. · Bioanalysis
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Oct 2012 |
62 |
| 29 |
Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes
Carl D. D’Ruiz, Donald W. Graff, Xiaoli Yan · BMC Public Health
Open access |
30 Sep 2015 |
61 |
| 30 |
Lack of Significant Effect of Bilastine Administered at Therapeutic and Supratherapeutic Doses and Concomitantly With Ketoconazole on Ventricular Repolarization: Results of a Thorough QT Study (TQTS) With QT‐Concentration Analysis
Benoît Tyl, Meriam Kabbaj, Sara M. Azzam et al. · The Journal of Clinical Pharmacology
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4 Jun 2011 |
61 |
| 31 |
A Microdose Cocktail to Evaluate Drug Interactions in Patients with Renal Impairment
Daniel A. Tatosian et al. · Clinical Pharmacology & Therapeutics
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24 Jul 2020 |
57 |
| 32 |
Inhibition of fatty acid synthase with FT‐4101 safely reduces hepatic de novo lipogenesis and steatosis in obese subjects with non‐alcoholic fatty liver disease: Results from two early‐phase randomized trials
Carine Beysen, Patricia E. Schroeder, Eric L. Wu et al. · Diabetes Obesity and Metabolism
Open access |
2 Dec 2020 |
55 |
| 33 |
Pharmacokinetic Drug–Drug Interaction of Apalutamide, Part 1: Clinical Studies in Healthy Men and Patients with Castration-Resistant Prostate Cancer
Ignacio Durán, Joan Carles, Iurie Bulat et al. · Clinical Pharmacokinetics
Open access |
27 Apr 2020 |
55 |
| 34 |
2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)
Lauren F. Stevenson et al. · Bioanalysis
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29 Nov 2018 |
55 |
| 35 |
Pharmacokinetics of cabozantinib tablet and capsule formulations in healthy adults
Linh Thuy Nguyen, Natacha Benrimoh, Yuli Xie et al. · Anti-Cancer Drugs
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3 May 2016 |
53 |
| 36 |
A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of JDTic
Jeffrey J. Buda, F. Ivy Carroll, Thomas R. Kosten et al. · Neuropsychopharmacology
Open access |
23 Jan 2015 |
52 |
| 37 |
A Novel NF‐κB Inhibitor, Edasalonexent (CAT‐1004), in Development as a Disease‐Modifying Treatment for Patients With Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects
Joanne M. Donovan, Michael Zimmer, Elliot M. Offman et al. · The Journal of Clinical Pharmacology
Open access |
11 Jan 2017 |
51 |
| 38 |
The Effects of the Antiplatelet Agents, Aspirin and Naproxen, on Pharmacokinetics and Pharmacodynamics of the Anticoagulant Edoxaban, a Direct Factor Xa Inhibitor
Jeanne Mendell, Frank X. Lee, Shuquan Chen et al. · Journal of Cardiovascular Pharmacology
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24 Apr 2013 |
50 |
| 39 |
Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD‐6972 in healthy subjects and subjects with type 2 diabetes mellitus
Eric G. Vajda, Douglas K. Logan, Kenneth C. Lasseter et al. · Diabetes Obesity and Metabolism
Open access |
8 Aug 2016 |
49 |
| 40 |
2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV) (Part 1 – Small Molecules, Peptides and Small Molecule Biomarkers by LCMS)
Eric Yang et al. · Bioanalysis
Open access |
7 Oct 2016 |
48 |
| 41 |
Predicting disease progression in progressive supranuclear palsy in multicenter clinical trials
Jee Bang, Iryna V. Lobach, Anthony E. Lang et al. · Parkinsonism & Related Disorders
Open access |
21 Apr 2016 |
48 |
| 42 |
The Effect of Single and Multiple Doses of Rifampin on the Pharmacokinetics of Doravirine in Healthy Subjects
Ka Lai Yee, Sauzanne G. Khalilieh, Rosa I. Sánchez et al. · Clinical Drug Investigation
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28 Mar 2017 |
46 |
| 43 |
Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Participants
Wendy Ankrom, Jialin Xu, Marie‐Helene Vallee et al. · The Journal of Clinical Pharmacology
Open access |
16 Apr 2020 |
45 |
| 44 |
Recommendations on The Interpretation of The New European Medicines Agency Guideline on Bioanalytical Method Validation By Global Cro Council For Bioanalysis (Gcc)
Mark Boterman et al. · Bioanalysis
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Mar 2012 |
45 |
| 45 |
Five-Day Changes in Biomarkers of Exposure Among Adult Smokers After Completely Switching From Combustible Cigarettes to a Nicotine-Salt Pod System
J. Bennett Jay, Erika L. Pfaunmiller, Norman Huang et al. · Nicotine & Tobacco Research
Open access |
31 Oct 2019 |
44 |
| 46 |
Intranasal NAP (davunetide) decreases tau hyperphosphorylation and moderately improves behavioral deficits in mice overexpressing α‐synuclein
Iddo Magen, Regina Ostritsky, Franziska Richter et al. · Pharmacology Research & Perspectives
Open access |
6 Aug 2014 |
44 |
| 47 |
2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 2 – Hybrid LBA/LCMS and Input from Regulatory Agencies)
An Song et al. · Bioanalysis
Open access |
18 Nov 2016 |
43 |
| 48 |
Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the “Double‐Negative” Scenario
Robert M. Lester · Clinical Pharmacology in Drug Development
Open access |
31 Jul 2021 |
42 |
| 49 |
2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘ Scientific ’? (Part 1 – LCMS: Small Molecules, Peptides and Small Molecule Biomarkers)
Jan Welink et al. · Bioanalysis
Open access |
Nov 2017 |
41 |
| 50 |
Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum
Mitchell F. Stiles, Leanne R. Campbell, Tao Jin et al. · Psychopharmacology
Open access |
3 May 2018 |
39 |