-
Application of Transthoracic Echocardiography for Cardiac Safety Evaluation in the Clinical Development Process of Vaccines Against Streptococcus pyogenes Drugs R D (IF 3.0) Pub Date : 2024-03-18 Usman Nakakana, Alimamy Serry-Bangura, Bassey Effiom Edem, Pietro Tessitore, Leonardo Di Cesare, Danilo Gomes Moriel, Audino Podda, Iris Sarah De Ryck, Ashwani Kumar Arora
-
Linezolid-Induced Thrombocytopenia in Patients with Renal Impairment: A Case Series, Review and Dose Advice Drugs R D (IF 3.0) Pub Date : 2024-03-14 S. R. E. Laarhuis, C. H. M. Kerskes, M. R. Nijziel, R. J. A. van Wensen, D. J. Touw
Background and Objective Oral linezolid is often used as alternative therapy for intravenous vancomycin. According to the current guidelines, no dose adjustment has to be made in case of renal impairment. Nevertheless, in our hospital we have seen several patients with renal impairment who developed linezolid-induced thrombocytopenia when linezolid was taken in the standard dose. In this case series
-
Effect of Daridorexant on the Pharmacokinetics of Midazolam, and on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects Drugs R D (IF 3.0) Pub Date : 2024-03-13 Isabelle Zenklusen, Jasper Dingemanse, Christian Reh, Martine Gehin, Priska Kaufmann
-
Bioequivalence Study of Tebipenem Pivoxil in Healthy Chinese Adults Drugs R D (IF 3.0) Pub Date : 2024-03-07 Rui Hao, Yiming Shao, Sisi Lin, Yi Wu, Li Bian, Yiwen Zhang
-
Case Report: Life-Threatening Fluoxetine-Linked Postoperative Bleeding Informed by Pharmacogenetic Evaluation Drugs R D (IF 3.0) Pub Date : 2024-02-28 Sara Rogers, Patrick J. Silva, George Udeani, Monica Deleon, Sriarchala Mutyala, Ladan Panahi, Asim Abu-Baker, Gabriel Neal, Kenneth S. Ramos
Background Selective serotonin reuptake inhibitors (SSRI) are commonly used for the treatment of depression and anxiety. Inhibition of serotonin reuptake in platelets increases bleeding risk in patients taking SSRIs. Case Here, we present the case of a 52-year-old patient who developed severe postsurgical bleeding requiring blood transfusion following panniculectomy. Conclusion SSRI-induced bleeding
-
Pharmacokinetic and Safety Study of Bismuth Potassium Citrate Formulations in Healthy Subjects Drugs R D (IF 3.0) Pub Date : 2024-02-12
Abstract Background Potassium bismuth citrate is a gastric mucosal protector and a key drug for treating peptic ulcers. Objective To evaluate the pharmacokinetic characteristics and safety of 120-mg bismuth potassium citrate formulations administered orally under fasting conditions in healthy Chinese subjects. Method A single-center open two-cycle trial was conducted on 12 healthy subjects who received
-
Real-World Experience of Carglumic Acid for Methylmalonic and Propionic Acidurias: An Interim Analysis of the Multicentre Observational PROTECT Study Drugs R D (IF 3.0) Pub Date : 2024-01-10 Sufin Yap, Delphine Lamireau, Francois Feillet, Angeles Ruiz Gomez, James Davison, Trine Tangeraas, Vincenzo Giordano
-
Drug–Drug Interaction Studies of Esmethadone (REL-1017) Involving CYP3A4- and CYP2D6-Mediated Metabolism Drugs R D (IF 3.0) Pub Date : 2023-11-27 Nicola Ferri, Sara De Martin, James Stuart, Sergio Traversa, Franco Folli, Marco Pappagallo, Cedric O’Gorman, Clotilde Guidetti, Andrea Mattarei, Charles E. Inturrisi, Paolo L. Manfredi
-
Unveiling the Influence of a High-Fat Meal on the Pharmacokinetics of Oral Globalagliatin, A Glucokinase Activator, in Healthy Chinese Volunteers Drugs R D (IF 3.0) Pub Date : 2023-11-20 Maodi Xu, Yaqin Wang, Xiaohu Wang, Zhichen Pu, Ya Liu, Cuilian Jiang, Xiaokun Shen, Hua Sun, Haitang Xie
-
Efficacy and Safety of Methylphenidate and Atomoxetine in Medication-Naive Children with Attention-Deficit Hyperactivity Disorder in a Real-World Setting Drugs R D (IF 3.0) Pub Date : 2023-11-20 Ying Zhang, Li Yin, Cun You, Chunxue Liu, Ping Dong, Xiu Xu, Kaifeng Zhang
-
A Guide to Expanding the Use of Buprenorphine Beyond Standard Initiations for Opioid Use Disorder Drugs R D (IF 3.0) Pub Date : 2023-11-08 James C. Miller, Michael A. Brooks, Kelly E. Wurzel, Emily J. Cox, John F. Wurzel
-
Effect of High-Fat Food on the Pharmacokinetic Profile and Safety of SAF-189s, an ALK/ROS1 Inhibitor, in Healthy Chinese Adults Drugs R D (IF 3.0) Pub Date : 2023-11-07 Huiling Qin, Yan Tan, Lei Diao, Ai-Min Hui, Zhuli Wu, Yongchun Zhou, Juan Sun, Xiao Xiang, Jingjun Qiu, Wei Hu
-
Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist Drugs R D (IF 3.0) Pub Date : 2023-11-02 Handan He, Jinzi J. Wu
-
Simvastatin Preferentially Targets FLT3/ITD Acute Myeloid Leukemia by Inhibiting MEK/ERK and p38-MAPK Signaling Pathways Drugs R D (IF 3.0) Pub Date : 2023-10-17 Genhong Li, Jingwei Yao, Zhen Lu, Lian Yu, Qinwei Chen, Lihong Ding, Zhihong Fang, Yin Li, Bing Xu
-
Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product Drugs R D (IF 3.0) Pub Date : 2023-10-13 Greg Cantin, Qian Liu, Bhavana Shah, Scott Kuhns, Mats Wikström, Shawn Cao, Jennifer Liu
-
Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers Drugs R D (IF 3.0) Pub Date : 2023-09-26 Ariel R. Topletz-Erickson, JoAl G. Mayor, Hsu-Tai Liu, Layth I. Abdulrasool, Christopher J. Endres
-
Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System Drugs R D (IF 3.0) Pub Date : 2023-09-12 Dehua Zhao, Xiaoqing Long, Jiping Zhou, Jisheng Wang
Background Infigratinib is a fibroblast growth factor receptor (FGFR)-specifc tyrosine kinase inhibitor indicated for the treatment of patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma. However, few studies have been conducted to evaluated the safety of infigratinib in the real world. In this study, we conducted a pharmacovigilance study to evaluate the
-
Looking into the Kinetics of NT-proBNP and sST2 Changes in Patients with Heart Failure Treated with Sacubitril/Valsartan: A Hint to Different Therapeutic Pathways Drugs R D (IF 3.0) Pub Date : 2023-09-13 Massimo Mapelli, Irene Mattavelli, Elisabetta Salvioni, Alice Bonomi, Nicolò Capra, Pietro Palermo, Cristina Banfi, Stefania Paolillo, Maria Luisa Biondi, Piergiuseppe Agostoni
-
The Benefits and Risks of Switching from Fingolimod to Siponimod for the Treatment of Relapsing–Remitting and Secondary Progressive Multiple Sclerosis Drugs R D (IF 3.0) Pub Date : 2023-08-28 Martin Vališ, Anat Achiron, Hans Peter Hartung, Jan Mareš, Veronika Tichá, Pavel Štourač, Simona Halusková, Francesco Angelucci, Zbyšek Pavelek
-
Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab Drugs R D (IF 3.0) Pub Date : 2023-08-26 Yijia Jiang, Taruna Arora, Scott Klakamp, Janice Davis, Yasmin A. Chandrasekher, Glen Young, Yue Du, Bin Yu, Karen J. Miller
-
In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period Drugs R D (IF 3.0) Pub Date : 2023-08-22 Minji Tak, Hawon Jeong, Jihoon Yun, Jihyun Kim, Soyeon Kim, Yoonsook Lee, Su Jin Park
-
Tremor Induced by Cyclosporine, Tacrolimus, Sirolimus, or Everolimus: A Review of the Literature Drugs R D (IF 3.0) Pub Date : 2023-08-22 Aparna Wagle Shukla, Caroline Lunny, Omar Mahboob, Uzair Khalid, Malea Joyce, Nivedita Jha, Nandakumar Nagaraja, Ashutosh M. Shukla
-
Comparative Efficacy of Different Drugs for the Treatment of Dilated Cardiomyopathy: A Systematic Review and Network Meta-analysis Drugs R D (IF 3.0) Pub Date : 2023-08-09 Xinyu Tong, Lijuan Shen, Xiaomin Zhou, Yudan Wang, Sheng Chang, Shu Lu
-
Risk of Hyponatremia after Tramadol/Acetaminophen Single-Pill Combination Therapy: A Real-World Study Based on the OMOP–CDM Database Drugs R D (IF 3.0) Pub Date : 2023-07-28 Yu Jeong Lee, Jinmi Kim, Youngmi Han, Kyuhyun Hwang, Byungkwan Choi, Tae Ryom Oh, Il Young Kim, Harin Rhee
-
Physicochemical and Functional Similarity Assessment Between Proposed Bevacizumab Biosimilar BAT1706 and Reference Bevacizumab Drugs R D (IF 3.0) Pub Date : 2023-07-22 Di Cao, Chunping Deng, Guangying Wang, Xiong Mei, Jianhua Xie, Yuanmei Liu, Yujie Liu, Yili Yang, Shengfeng Li, Cuihua Liu
-
Efficacy and Safety of Apatinib in Patients with Recurrent Glioblastoma Drugs R D (IF 3.0) Pub Date : 2023-07-19 Hao Lin, Xinli Zhou, Xiaofang Sheng, Xiaohua Liang
-
Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo®] Obtained from a Manufacturing Process Preserving IgA/IgM Potential of Human Plasma Drugs R D (IF 3.0) Pub Date : 2023-07-19 Christian Duellberg, Achim Hannappel, Steffen Kistner, Oliver Maneg
-
Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers Drugs R D (IF 3.0) Pub Date : 2023-07-12 Samira Ait Abdellah, Véronique Raverot, Caroline Gal, Isabelle Guinobert, Valérie Bardot, Claude Blondeau, Bruno Claustrat
-
Hepatotoxicity of AKR1C3 Inhibitor BAY1128688: Findings from an Early Terminated Phase IIa Trial for the Treatment of Endometriosis Drugs R D (IF 3.0) Pub Date : 2023-07-09 Jan Hilpert, Esther Groettrup-Wolfers, Hristiyan Kosturski, Laura Bennett, Catriona L. K. Barnes, Kerstin Gude, Isabella Gashaw, Stefanie Reif, Thomas Steger-Hartmann, Christian Scheerans, Alexander Solms, Antje Rottmann, Guangping Mao, Charles Chapron
-
Bioavailability of Cariban® Capsules: A Modified-Release Fixed-Dose Combination of Doxylamine and Pyridoxine to Relieve Nausea and Vomiting During Pregnancy Drugs R D (IF 3.0) Pub Date : 2023-06-15 Paula Saz-Leal, Laura Zamorano-Domínguez, Jesús Frías, Pedro Guerra, Marc Saura-Valls, Ramón Roca-Juanes, Joaquín Nebot-Troyano, Eva García-Aguilar, Tatiana Vilchez, Katia Urso
-
Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies Drugs R D (IF 3.0) Pub Date : 2023-06-10 Dejan Krajcar, Rebeka Jereb, Igor Legen, Jerneja Opara, Iztok Grabnar
Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development. The objective of this research was to evaluate the associations between solubility and acido-basic parameters of an active pharmaceutical ingredient (API), study conditions and bioequivalence outcome. Methods We retrospectively analyzed
-
N-Acetyl-L-Cysteine Reduces Cervical Carcinogenesis by Promoting Apoptosis Drugs R D (IF 3.0) Pub Date : 2023-06-02 Wenping Guo, Wang Jing
-
A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin®) in Healthy Chinese Males Drugs R D (IF 3.0) Pub Date : 2023-05-29 Jing Wu, Guolan Wu, Liangzhi Xie, Duo Lv, Chang Xu, Huili Zhou, Lihua Wu, Jingjing Zhang, Jianzhong Shentu
-
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma Drugs R D (IF 3.0) Pub Date : 2023-05-15 Takuji Okusaka, Manabu Morimoto, Yuichiro Eguchi, Shinichiro Nakamura, Shuichi Iino, Rie Kageyama
Background and Objective For patients with advanced hepatocellular carcinoma (HCC), the standard of care for many years has been sorafenib. Preliminary data have suggested that the combination of the NAD(P)H:quinone oxidoreductase 1 bioactivatable agent napabucasin plus sorafenib may improve clinical outcomes in patients with HCC. In this phase I, multicenter, uncontrolled, open-label study, we evaluated
-
Safety and Effectiveness of Rasburicase in the Control of Hyperuricemia in Pediatric Patients with Non-Hodgkin’s Lymphoma and Acute Leukemia: An Open-Label, Single-Arm, Multi-center, Interventional Study Drugs R D (IF 3.0) Pub Date : 2023-05-10 Tianyou Wang, Xiaofan Zhu, Yumei Chen, Shuhong Shen, Yongmin Tang, Jingying Zhang, Yingyi He, Hui Zhang, Ju Gao, Jianpei Fang, Rong Liu, Xiaoyan Wu, Jinchuan Sun, Minlu Zhang
-
Single-Centre Real-World Study on Drug Survival and Effectiveness of Brodalumab for Treatment of Psoriasis and Psoriatic Arthritis Drugs R D (IF 3.0) Pub Date : 2023-05-08 Cathrine Dawn Büttner Elgaard, Lars Iversen, Kasper Fjellhaugen Hjuler
-
Estetrol: From Preclinical to Clinical Pharmacology and Advances in the Understanding of the Molecular Mechanism of Action Drugs R D (IF 3.0) Pub Date : 2023-05-03 Céline Gérard, Jean-Michel Foidart
-
Development of a Biosimilar of Agalsidase Beta for the Treatment of Fabry Disease: Preclinical Evaluation Drugs R D (IF 3.0) Pub Date : 2023-04-21 André B. P. van Kuilenburg, Carla E. M. Hollak, Ana Travella, Melisa Jacobs, Lucas D. Gentilini, René Leen, Karen M. M. Ghauharali-van der Vlugt, Femke S. Beers Stet, Susan M. I. Goorden, Sanne van der Veen, Marcelo Criscuolo, Mariana Papouchado
-
Pharmacokinetics and Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, Three-Period, Three-Sequence Crossover Study Drugs R D (IF 3.0) Pub Date : 2023-04-03 Zhao-xin Wu, Chen-jing Wang, Ping Shi, Yan-ping Liu, Ting Li, Fei-fei Sun, Yao Fu, Xiao-meng Gao, Ya-ping Ma, Yu Cao
-
Efficacy of Baricitinib in Patients with Refractory Adult-Onset Still’s Disease Drugs R D (IF 3.0) Pub Date : 2023-04-03 Ziyi Sun, Rongqi Li, Yingai Wang, Feng Han, Wei Wei, Xin Li
-
Case Report: Simultaneously Induced Neutropenia and Hemolysis After a Single Metamizole Dose Drugs R D (IF 3.0) Pub Date : 2023-03-29 Raphael Allgaier, Arne Kandulski, Karsten Gülow, Lars Maier, Martina Müller, Hauke Christian Tews
-
A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug- and Medical Device-Borne Endotoxin Drugs R D (IF 3.0) Pub Date : 2023-02-24 Edward C. Tidswell
-
Development of the Drug Product Formulation of the Bevacizumab Biosimilar PF-06439535 (Bevacizumab-bvzr) Drugs R D (IF 3.0) Pub Date : 2023-02-22 Rebecca L. Ingram, Sarah E. Weiser
-
Risk of Adverse Events Associated with Domperidone and Metoclopramide in Gastroparesis: Systematic Review and Meta-analysis Drugs R D (IF 3.0) Pub Date : 2023-02-07 Daniela R. Junqueira, Dimitri Bennett, Susanna Y. Huh, Kyle Fahrbach, Binod Neupane, Marissa Betts
-
A Randomised Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Palovarotene Ophthalmic Solution Drugs R D (IF 3.0) Pub Date : 2022-12-21 William J. Foster, Andrew L. Strahs, Kent W. Small, James M. Roach
-
Benefits of Hydroxychloroquine Combined with Low-Dose Aspirin on Pregnancy Outcomes and Serum Cytokines in Pregnant Women with Systemic Lupus Erythematosus Drugs R D (IF 3.0) Pub Date : 2022-11-30 Na Zhang, Hong-Xia Zhang, Yu-Wei Li, Yuan Li
-
Analyses of Basal and Squamous Cell Carcinoma Reported as an Adverse Drug Reaction and Comparison with Cases from the Cancer Registry from Germany Drugs R D (IF 3.0) Pub Date : 2022-11-19 Diana Dubrall, Bernhardt Sachs, Klaus Kraywinkel, Maike Schulz, Matthias Schmid, Wilma Fischer-Barth, Jens Bate
-
Pharmacokinetics, Bioequivalence and Safety of Cloperastine in Chinese Healthy Subjects Under Fasting and Postprandial Conditions Drugs R D (IF 3.0) Pub Date : 2022-11-11 Hong-Yu Luo, Hui-Zhi Long, Zi-Wei Zhou, Shuo-Guo Xu, Feng-Jiao Li, Yan Cheng, Dan-Dan Wen, Ping Deng, Li-Chen Gao
-
Chinese- and French-Manufactured Immediate-Release Glucophage® Bioequivalence: A Randomized, Open-Label, Crossover Study Drugs R D (IF 3.0) Pub Date : 2022-10-20 Chaoying Hu, Dan Gao, Dandan Li, Dongli Zhou, Lan Zhang
-
Clinical Validation of the Covariates Pharmacokinetic Model for Propofol in an Adult Population Drugs R D (IF 3.0) Pub Date : 2022-10-07 Christopher Hawthorne, Martin Shaw, Ruaraidh Campbell, Nicholas Sutcliffe, Shiona McKelvie, Stefan Schraag
-
Quercetin Supplement to Aspirin Attenuates Lipopolysaccharide-Induced Pre-eclampsia-Like Impairments in Rats Through the NLRP3 Inflammasome Drugs R D (IF 3.0) Pub Date : 2022-09-22 Shuangyan Yang, Junfeng Zhang, Dan Chen, Jie Ding, Yanhong Zhang, Lili Song
-
Impact of Renal Function on Anti-factor Xa Activity Concentrations with Edoxaban Use in Patients with Non-valvular Atrial Fibrillation Drugs R D (IF 3.0) Pub Date : 2022-09-14 Ryohei Ono, Kazutaka Nishimura, Hidehisa Takahashi, Yasuhiko Hori, Kenichi Fukushima, Yoshio Kobayashi
-
Roxadustat for SARS-CoV-2 Infection: Old Signaling Raised New Hopes Drugs R D (IF 3.0) Pub Date : 2022-08-25 Luay Alkazmi, Hayder M. Al-kuraishy, Gaber El-Saber Batiha, Gomaa Mostafa-Hedeab, Michel De Waard, Jean-Marc Sabatier, Saeed M. Kabrah, Hebatallah M. Saad, Ali I. Al-Gareeb, Jesus Simal-Gandara
-
Novel Strategies for the Treatment of COVID-19 Drugs R D (IF 3.0) Pub Date : 2022-08-24 Matthew W. McCarthy
On 4 September, 2020, the US National Institutes of Health launched a new clinical trial, “A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults with COVID-19.” This open-label, placebo-controlled, multicenter, adaptive platform study was designed to evaluate therapeutic options for patients hospitalized
-
Risk Factors for Septic Shock After Irinotecan-Containing Chemotherapy: An Exploratory Case-Control Study Drugs R D (IF 3.0) Pub Date : 2022-08-20 Maki Umemiya, Yoshihide Inayama, Eiji Nakatani, Kenta Ito, Mitsuru Tsuji, Teruki Yoshida, Sae Yu, Rei Gou, Naoki Horikawa, Hirohiko Tani, Kenzo Kosaka
-
Study of the Stability of Sandoz Rituximab Biosimilar Rixathon®/Riximyo® When Subjected for up to 21 Days to Ambient Storage Drugs R D (IF 3.0) Pub Date : 2022-08-07 Roman Borišek, André Mischo, Ida Šmid
-
Antiplatelets Versus Anticoagulation in Cervical Artery Dissection: A Systematic Review and Meta-analysis of 2064 Patients Drugs R D (IF 3.0) Pub Date : 2022-08-03 Abdulrahman Ibrahim Hagrass, Bashar Khaled Almaghary, Mohamed Abdelhady Mostafa, Mohamed Elfil, Sarah Makram Elsayed, Amira A. Aboali, Aboalmagd Hamdallah, Mohammed Tarek Hasan, Mohammed Al-kafarna, Khaled Mohamed Ragab, Mohamed Fahmy Doheim
-
Effectiveness and Safety of Upadacitinib in the Treatment of Moderate-Severe Atopic Dermatitis: A Multicentric, Prospective, Real-World, Cohort Study Drugs R D (IF 3.0) Pub Date : 2022-08-03 Andrea Chiricozzi, Niccolò Gori, Alessandra Narcisi, Anna Balato, Alessio Gambardella, Michela Ortoncelli, Angelo Valerio Marzano, Riccardo Balestri, Giovanni Palazzo, Michele Pellegrino, Marco Romanelli, Giovanni Tripepi, Ketty Peris, Antonio Costanzo
-
Bioavailability of Oniria®, a Melatonin Prolonged-Release Formulation, Versus Immediate-Release Melatonin in Healthy Volunteers Drugs R D (IF 3.0) Pub Date : 2022-08-02 Manuel Román Martinez, Eva García Aguilar, Samuel Martin Vílchez, Javier González García, Sergio Luquero-Bueno, Paola Camargo-Mamani, Gina Mejia-Abril, Laura García-Castro, Alejandro de Miguel-Cáceres, Paula Saz-Leal, Francisco Abad-Santos, Concepcion Nieto Magro, Dolores Ochoa Mazarro
-
Association between Acid-Suppressive Drugs and Clinical Outcomes in Patients with Nonvalvular Atrial Fibrillation Drugs R D (IF 3.0) Pub Date : 2022-07-19 Hideki Arai, Shinichiro Ueda, Kazutaka Uchida, Fumihiro Sakakibara, Norito Kinjo, Mari Nezu, Takeshi Morimoto