听力与言语-语言病理学

行为科学

医学伦理学

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  • Pilot Study of Peak Plasma Concentration After High-Dose Oral Montelukast in Children With Acute Asthma Exacerbations.

    abstract::Acute asthma exacerbations are primarily due to airway inflammation and remain one of the most frequent reasons for childhood hospitalizations. Although systemic corticosteroids remain the mainstay of therapy because of their anti-inflammatory properties, not all inflammatory pathways are responsive to systemic cortic...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1738

    authors: Arnold DH,Van Driest SL,Reiss TF,King JC,Akers WS

    更新日期:2021-03-01 00:00:00

  • Evaluation of the Relationship of Glasdegib Exposure and Safety End Points in Patients With Refractory Solid Tumors and Hematologic Malignancies.

    abstract::Glasdegib is approved for treating acute myeloid leukemia in elderly patients at 100 mg once daily in combination with low-dose cytarabine. Exposure-efficacy analysis showed that the survival benefit of glasdegib was not glasdegib exposure-dependent. The relationship between glasdegib exposure and adverse event (AE) c...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1742

    authors: Ruiz-Garcia A,Shaik N,Lin S,Jamieson C,Heuser M,Chan G

    更新日期:2021-03-01 00:00:00

  • Treatment With Tocilizumab for Patients With COVID-19 Infections: A Case-Series Study.

    abstract::Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 receptor, holds the potential for treating coronavirus disease 2019 (COVID-19) patients, particularly those at high risk of cytokine storm syndrome. However, data regarding the clinical impact of treatment with TCZ in patients with COVID-19...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1787

    authors: Mo Y,Adarkwah O,Zeibeq J,Pinelis E,Orsini J,Gasperino J

    更新日期:2021-03-01 00:00:00

  • Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism.

    abstract::This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open-label study was conducted in children who required anticoagulation for the treatment of VTE. The study population included children with and without cancer. ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1716

    authors: Damle B,Jen F,Sherman N,Jani D,Sweeney K

    更新日期:2021-02-01 00:00:00

  • Development and Verification of a Body Weight-Directed Disease Trial Model for Glucose Homeostasis.

    abstract::Weight loss has been associated with improvement in insulin sensitivity. It is consequently a cornerstone in the management of type 2 diabetes mellitus (T2DM). However, the strictly quantitative relationship between weight loss, insulin sensitivity, and clinically relevant glucose homeostasis biomarkers as well as cha...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1728

    authors: Farhan N,Gebert I,Xing Y,Wieser K,Lingineni K,Ma X,Chien JY,Garhyan P,Schmidt S

    更新日期:2021-02-01 00:00:00

  • Application of Individualized PBPK Modeling of Rate Data (iPBPK-R) to Evaluate the Effect of Hemodialysis On Nonrenal Clearance Pathways.

    abstract::The aim of this study was to apply individualized, physiologically-based pharmacokinetic (iPBPK-R) modeling of 14 CO2 production rates measured by the erythromycin breath test (ERMBT) to characterize the effect of hemodialysis on the function of nonrenal clearance pathways in patients with end-stage renal disease (ESR...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1818

    authors: Franchetti Y,Nolin TD

    更新日期:2021-01-18 00:00:00

  • Optimal Designs for Model-Based Assessment of Insulin Sensitivity and Glucose Effectiveness.

    abstract::The integrated minimal model allows assessment of clinical diagnosis indices, for example, insulin sensitivity (SI ) and glucose effectiveness (SG ), from data of the insulin-modified intravenous glucose tolerance test (IVGTT), which is laborious with an intense sampling schedule, up to 32 samples. The aim of this stu...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1707

    authors: Ibrahim MMA,Redestad E,Kjellsson MC

    更新日期:2021-01-01 00:00:00

  • Estimation of Attainment of Steady-State Conditions for Compounds With a Long Half-Life.

    abstract::Half-life is a standard result reported with analysis of pharmacokinetic data. Different definitions such as noncompartmental half-life, terminal half-life, effective half-life, and context-sensitive half-life can yield substantially different estimates of the quantity "half-life." Time to attainment of steady-state c...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1701

    authors: Krause A,Lott D,Dingemanse J

    更新日期:2021-01-01 00:00:00

  • Effect of Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of the Iminosugar Sinbaglustat.

    abstract::Sinbaglustat (ACT-519276), a brain-penetrating inhibitor of glucosylceramide synthase and nonlysosomal glucosylceramidase, is developed as a new therapy for lysosomal storage disorders. In the first-in-human study, sinbaglustat was primarily excreted unchanged in urine. This study was conducted to evaluate the effect ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1808

    authors: Melchior M,Dingemanse J,Alatrach A,Feldkamp T,Sidharta PN,Géhin M

    更新日期:2020-12-23 00:00:00

  • Model-Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis.

    abstract::The selective T-cell costimulation modulator abatacept is approved for treatment of adult rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA; 6-17 years [intravenous] and 2-17 years [subcutaneous]). An extrapolation approach was taken to determine subcutaneous weight-tiered doses of abatac...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1797

    authors: Gandhi Y,Passarell JA,Roy A,Murthy B

    更新日期:2020-12-07 00:00:00

  • Population Pharmacokinetics and Exposure-Response Analyses for the Most Frequent Adverse Events Following Treatment With Lemborexant, an Orexin Receptor Antagonist, in Subjects With Insomnia Disorder.

    abstract::Lemborexant is a novel orexin receptor antagonist approved in the United States and Japan for the treatment of insomnia. This article describes the population pharmacokinetics (PK) of lemborexant and the relationship of its daily steady-state exposure (Cav,ss ) to the probability of most frequent treatment-emergent ad...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1683

    authors: Lalovic B,Majid O,Aluri J,Landry I,Moline M,Hussein Z

    更新日期:2020-12-01 00:00:00

  • Dosing Recommendations for Pediatric Patients With Renal Impairment.

    abstract::A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1676

    authors: Al-Khouja A,Park K,Anderson DJC,Young C,Wang J,Huang SM,Khurana M,Burckart GJ

    更新日期:2020-12-01 00:00:00

  • Drug-Drug Interaction Studies With Oral Contraceptives: Pharmacokinetic/Pharmacodynamic and Study Design Considerations.

    abstract::Oral contraceptives (OCs) are the most widely used form of birth control among women of childbearing potential. Knowledge of potential drug-drug interactions (DDIs) with OCs becomes imperative to provide information on the medication to women of childbearing potential and enable their inclusion in clinical trials, esp...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1765

    authors: Sun H,Sivasubramanian R,Vaidya S,Barve A,Jarugula V

    更新日期:2020-12-01 00:00:00

  • Local Investigators Significantly Overestimate Overall Response Rates Compared to Blinded Independent Central Reviews in Phase 2 Oncology Trials.

    abstract::The overall response rate (ORR) is a largely adopted outcome measure in early-phase oncology trials. ORR is highly relevant in cancer drug development at the time of deciding whether to move to confirmatory phase 3 trials; moreover, ORR is gaining increasing relevance in fast-track registration procedures. No systemat...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1790

    authors: Dello Russo C,Cappoli N,Pilunni D,Navarra P

    更新日期:2020-11-26 00:00:00

  • Antiretrovirals for Prophylaxis Against COVID-19: A Comprehensive Literature Review.

    abstract::Although people living with human immunodeficiency virus and other comorbidities are expected to experience more grievous consequences with corona virus disease 2019 (COVID-19), recent cohort studies did not indicate this. Antiretrovirals (ARVs) might have a prophylactic role in these patients. The purpose of this stu...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1788

    authors: Alavian G,Kolahdouzan K,Mortezazadeh M,Torabi ZS

    更新日期:2020-11-20 00:00:00

  • Exposure-Response Analyses for Upadacitinib Efficacy in Subjects With Atopic Dermatitis-Analyses of Phase 2b Study to Support Selection of Phase 3 Doses.

    abstract::Upadacitinib is a selective Janus kinase 1 inhibitor that was recently approved for treatment of rheumatoid arthritis and is currently being evaluated for treatment of several other autoimmune diseases, including atopic dermatitis (AD). The relationships between upadacitinib plasma exposure and efficacy (assessed as E...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1782

    authors: Mohamed MF,Gopalakrishnan S,Teixeira HD,Othman AA

    更新日期:2020-11-06 00:00:00

  • Target-Mediated Drug Disposition-A Class Effect of Soluble Epoxide Hydrolase Inhibitors.

    abstract::Pharmacological target-mediated drug disposition (TMDD) represents a special source of nonlinear pharmacokinetics, and its occurrence in large-molecule compounds has been well recognized because numerous protein drugs have been reported to have TMDD due to specific binding to their pharmacological targets. Although TM...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1763

    authors: An G,Lee KSS,Yang J,Hammock BD

    更新日期:2020-10-19 00:00:00

  • Rivaroxaban as an Alternative Agent for Heparin-Induced Thrombocytopenia.

    abstract::Heparin-induced thrombocytopenia (HIT) is a high-risk adverse drug reaction because of its associated risk of life- and limb-threatening thrombosis. Rivaroxaban may be considered as an ideal nonheparin anticoagulant alternative for the management of HIT. In this preliminary retrospective study, the efficacy and safety...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1635

    authors: Farasatinasab M,Zarei B,Moghtadaei M,Nasiripour S,Ansarinejad N,Zarei M

    更新日期:2020-10-01 00:00:00

  • Utility of Quantitative Proteomics for Enhancing the Predictive Ability of Physiologically Based Pharmacokinetic Models Across Disease States.

    abstract::Disease states such as liver cirrhosis and chronic kidney disease can lead to altered pharmacokinetics (PK) of drugs by influencing drug absorption, blood flow to organs, plasma protein binding, apparent volume of distribution, and drug-metabolizing enzyme and transporter (DMET) abundance. Narrow therapeutic index dru...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1709

    authors: Sharma S,Suresh Ahire D,Prasad B

    更新日期:2020-10-01 00:00:00

  • Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Participants.

    abstract::The incidence of migraine is higher among women than men and peaks during the reproductive years, when contraceptive medication use is common. Atogepant, a potent, selective antagonist of the calcitonin gene-related peptide receptor-in development for migraine prevention-is thus likely to be used by women taking oral ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1610

    authors: Ankrom W,Xu J,Vallee MH,Dockendorf MF,Armas D,Boinpally R,Min KC

    更新日期:2020-09-01 00:00:00

  • Gastrointestinal Tolerability and Absorption of R- Versus R,S-Lipoic Acid in Progressive Multiple Sclerosis: A Randomized Crossover Trial.

    abstract::We compared the gastrointestinal (GI) tolerability and assessed for bioequivalent absorption of R-lipoic acid (LA) in people with progressive multiple sclerosis (MS) in a single-center, double-blind, randomized crossover trial. Participants randomly assigned to formulation sequence took 600 mg of R-LA or 1200 mg of a ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1605

    authors: Cameron M,Taylor C,Lapidus J,Ramsey K,Koop D,Spain R

    更新日期:2020-08-01 00:00:00

  • A Randomized, Doubled-Blind Clinical Trial on the Effect of Zataria multiflora on Clinical Symptoms, Oxidative Stress, and C-Reactive Protein in COPD Patients.

    abstract::The effects of Zataria multiflora on clinical symptoms, pulmonary function tests, oxidative stress, and C-reactive protein levels in chronic obstructive pulmonary disease (COPD) patients were evaluated. Forty-five patients were allocated to 3 groups: placebo group and 2 groups that received 3 and 6 mg/kg/day Z. multif...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1586

    authors: Ghorani V,Rajabi O,Mirsadraee M,Rezaeitalab F,Saadat S,Boskabady MH

    更新日期:2020-07-01 00:00:00

  • Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.

    abstract::Chemotherapy-induced nausea and vomiting (CINV) is a common treatment-related adverse event that negatively impacts the quality of life of cancer patients. During pediatric drug development, extrapolation of efficacy from adult to pediatric populations is a pathway that can minimize the exposure of children to unneces...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1577

    authors: Momper JD,Heinrichs MT,Krudys K,Griebel D,Kumar S,Kim I,Mehrotra N,Mulberg AE,Garimella N,Nelson R,Reaman G,Sinha V,Yao L,Zineh I,Burckart G,Sachs H,Mulugeta Y

    更新日期:2020-06-01 00:00:00

  • A Drug-Drug Interaction Study to Evaluate the Effect of TAS-303 on CYP3A Activity in the Small Intestine and Liver.

    abstract::TAS-303 (4-piperidinyl 2,2-diphenyl-2-[propoxy-1,1,2,2,3,3,3-d7 ] acetate hydrochloride) is a novel selective noradrenaline reuptake inhibitor being developed for the treatment of stress urinary incontinence. An in vitro study and a physiologically based pharmacokinetic model simulation showed that TAS-303 had inhibit...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1583

    authors: Kumagai Y,Fujita T,Maeda M,Sasaki Y,Nagaoka M,Huang J,Takenaka T,Kawai M

    更新日期:2020-06-01 00:00:00

  • Physiologically Based Pharmacokinetic Approach Can Successfully Predict Pharmacokinetics of Citalopram in Different Patient Populations.

    abstract::A physiologically based pharmacokinetic model (PBPK) was built for citalopram using Simcyp-based absorption, distribution, metabolism, and excretion simulator. Various physicochemical properties of citalopram were obtained from the published literature. The in vitro-in vivo extrapolation method was used to predict cle...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1541

    authors: Wu X,Zhang H,Miah MK,Caritis SN,Venkataramanan R

    更新日期:2020-04-01 00:00:00

  • A Population Pharmacokinetic Model of Oral Docetaxel Coadministered With Ritonavir to Support Early Clinical Development.

    abstract::Oral administration of docetaxel is an attractive alternative for conventional intravenous (IV) administration. The low bioavailability of docetaxel, however, hinders the application of oral docetaxel in the clinic. The aim of the current study was to develop a population pharmacokinetic (PK) model for docetaxel and r...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1532

    authors: Yu H,Janssen JM,Sawicki E,van Hasselt JGC,de Weger VA,Nuijen B,Schellens JHM,Beijnen JH,Huitema ADR

    更新日期:2020-03-01 00:00:00

  • Effects of Adding Pentoxifylline to Captopril on Primary Hypertension: A Pilot Randomized Clinical Trial.

    abstract::Because of the key role blood viscosity plays in the regulation of blood pressure (BP) and the hemorheological effects of pentoxifylline (PTX), this study was conducted to evaluate whether PTX can reduce BP when added to captopril in patients with stage 1 hypertension. In this randomized clinical trial 62 patients wit...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1516

    authors: Namdar H,Khani E,Pourrashid MH,Entezari-Maleki T

    更新日期:2020-02-01 00:00:00

  • A Retrospective Review of the Efficiency of First-Dose Therapeutic Drug Monitoring of Gentamicin, Amikacin, and Vancomycin in the Pediatric Population.

    abstract::Therapeutic drug monitoring (TDM) has become standard clinical practice for gentamicin, amikacin, and vancomycin to optimize efficacy and reduce toxicity. TDM after the first dose of antibiotic was adopted in our institution. This study aims to evaluate if target therapeutic drug concentrations could be achieved more ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1509

    authors: Lim WXS,Chua WBB,Chua JM,Lee Q,Chan JW,Sultana R,Poh BH

    更新日期:2020-01-01 00:00:00

  • Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.

    abstract::Intravenous administration of acetaminophen is an alternative to the oral and rectal routes, which may be contraindicated in particular clinical settings. This randomized, placebo-controlled study of intravenous acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals, Bedminster, New Jersey) in neonate and infant patient...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1508

    authors: Hammer GB,Maxwell LG,Taicher BM,Visoiu M,Cooper DS,Szmuk P,Pheng LH,Gosselin NH,Lu J,Devarakonda K

    更新日期:2020-01-01 00:00:00

  • First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of an Oral Formulation of DS-1040, an Inhibitor of the Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor, in Healthy Subjects.

    abstract::DS-1040, a low-molecular-weight imidazole derivative, inhibits the enzymatic activity of thrombin-activatable fibrinolysis inhibitor (TAFIa), enhancing endogenous tissue plasminogen activator-triggered fibrinolysis. This first-in-human, randomized, placebo-controlled, phase 1 study evaluated the safety, pharmacokineti...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/jcph.1474

    authors: Zhou J,Limsakun T,Yin O,Warren V,Zamora C,Atiee G,Kochan J,Pav J,Kobayashi F,Vashi V,Dishy V

    更新日期:2019-12-01 00:00:00

  • Alternative Magnesium Sulfate Dosing Regimens for Women With Preeclampsia: A Population Pharmacokinetic Exposure-Response Modeling and Simulation Study.

    abstract::Magnesium sulfate is the anticonvulsant of choice for eclampsia prophylaxis and treatment; however, the recommended dosing regimens are costly and cumbersome and can be administered only by skilled health professionals. The objectives of this study were to develop a robust exposure-response model for the relationship ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1448

    authors: Du L,Wenning LA,Carvalho B,Duley L,Brookfield KF,Witjes H,de Greef R,Lumbiganon P,Titapant V,Kongwattanakul K,Long Q,Sangkomkamhang US,Gülmezoglu AM,Oladapo OT

    更新日期:2019-11-01 00:00:00

  • Off-Label Treatment of 4 Amyotrophic Lateral Sclerosis Patients With 4-Aminopyridine.

    abstract::Amyotrophic lateral sclerosis (ALS) is a fatal disorder characterized by degeneration of the upper and lower motor neuron. Among the at least 25 known genes associated with familial (hereditary) and sporadic ALS, mutations in fused-in-sarcoma (FUS) and superoxide dismutase 1 (SOD1) have been extensively investigated i...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1437

    authors: Peikert K,Naumann M,Günther R,Wegner F,Hermann A

    更新日期:2019-10-01 00:00:00

  • Evaluation of Weight Thresholds for Pediatric Patients to Use Adult Dosage of Therapeutic Monoclonal Antibodies.

    abstract::With increasing interest in enrolling adolescent patients in adult trials, a question often arises: when can pediatric patients use adult dosages? For currently approved therapeutic monoclonal antibodies (mAbs) with equivalent adult and pediatric indications, body weight thresholds for pediatric patients to receive ad...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1434

    authors: Yang N,Xu MC,Yao Z

    更新日期:2019-10-01 00:00:00

  • Pharmacogenetic Analysis of OATP1B1, UGT1A1, and BCRP Variants in Relation to the Pharmacokinetics of Letermovir in Previously Conducted Clinical Studies.

    abstract::The cytomegalovirus (CMV) viral terminase inhibitor letermovir is indicated for prevention of CMV infection in CMV-seropositive allogeneic hematopoietic stem cell transplant recipients. In this analysis, functional variants in solute carrier organic anion transporter family member 1B1 (SLCO1B1), uridine diphosphate-gl...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1420

    authors: Kobie J,Guo Z,Cho CR,Menzel K,McCrea JB,Blanchard R,Shaw PM

    更新日期:2019-09-01 00:00:00

  • Effect of Intravenous Oxycodone Versus Sufentanil on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery.

    abstract::More than 30% of patients who undergo surgery will experience postoperative nausea and vomiting (PONV) if no prophylactic treatments are used. Although numerous studies have been performed to investigate the factors related to PONV, the effect of perioperative intravenous oxycodone on the incidence of PONV has not bee...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/jcph.1408

    authors: Tao B,Liu K,Wang D,Ding M,Zhao P

    更新日期:2019-08-01 00:00:00

  • A Phase 1, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment.

    abstract::The pharmacokinetics and safety of a single oral dose of 200-mg plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD) in oral solution (Epidiolex in the United States; 100 mg/mL) were assessed in subjects with mild to severe hepatic impairment (n =  8 each for mild and moderate, n = 6 for sever...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1002/jcph.1412

    authors: Taylor L,Crockett J,Tayo B,Morrison G

    更新日期:2019-08-01 00:00:00

  • Comparison of the Pharmacokinetic Properties of Naloxone Following the Use of FDA-Approved Intranasal and Intramuscular Devices Versus a Common Improvised Nasal Naloxone Device.

    abstract::For more than a decade, first responders and the general public have been able to treat suspected opioid overdoses using an improvised nasal naloxone device (INND) constructed from a prefilled syringe containing 2 mg of naloxone (1 mg/mL) attached to a mucosal atomization device. In recent years, the U.S. Food and Dru...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/jcph.1401

    authors: Krieter PA,Chiang CN,Gyaw S,McCann DJ

    更新日期:2019-08-01 00:00:00

  • A Mechanism-Based Population Pharmacokinetics Model of Erythropoietin in Premature Infants and Healthy Adults Following Multiple Intravenous Doses.

    abstract::The objective of the current study was to develop a population pharmacokinetics (PK) model for erythropoietin (Epo) in premature infants and healthy adults to characterize the variation in PK, and to study the differences in Epo PK in these 2 populations. Thirteen very low-birth-weight premature infants (<1500 g at bi...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1368

    authors: D'Cunha R,Widness JA,Yan X,Schmidt RL,Veng-Pedersen P,An G

    更新日期:2019-06-01 00:00:00

  • Population Pharmacokinetics and Exposure-Response Analyses for CPX-351 in Patients With Hematologic Malignancies.

    abstract::CPX-351, a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a synergistic ratio, is approved in the United States for adults with newly diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes. Population pharmacokinetics analyses were performed ...

    journal_title:Journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1002/jcph.1366

    authors: Wang Q,Banerjee K,Vasilinin G,Marier JF,Gibbons JA

    更新日期:2019-05-01 00:00:00

  • Simplification of Imipenem Dosing by Removal of Weight-Based Adjustments.

    abstract::In patients with renal insufficiency, dose adjustments based on creatinine clearance and body weight have been a component of imipenem dosage instructions. The objective of the current analysis was to provide revised dosing recommendations by evaluating the impact of creatinine clearance and body weight on the pharmac...

    journal_title:Journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1002/jcph.1356

    authors: Lala M,Brown M,Kantesaria B,Walker B,Paschke A,Rizk ML

    更新日期:2019-05-01 00:00:00

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