Edward C Tidswell
BACKGROUND: A thorough and systematic analysis of potential endotoxin-related safety issues from parenteral drugs and devices is important to ensure appropriate current Good Manufacturing Practices, compendial requirements, standards and regulatory guidance. Lately, the US Food and Drug Administration has been expecting pharmaceutical firms to apply an arbitrary safety factor to compendial compliant drug specifications for endotoxin, potentially causing manufacturing challenges, supply issues and additional unwarranted costs...
February 24, 2023: Drugs in R&D
Rebecca L Ingram, Sarah E Weiser
BACKGROUND: PF-06439535 (bevacizumab-bvzr; Zirabev® ) is a biosimilar of bevacizumab reference product (RP; Avastin® ). This study describes the formulation development for PF-06439535. METHODS: PF-06439535 was formulated in several buffers and stored for 12 weeks at 40 °C to determine the optimal buffer and pH under stressed conditions. Subsequently, PF-06439535 at 100 and 25 mg/mL was formulated in a succinate buffer with sucrose, edetate disodium dihydrate (EDTA), and polysorbate 80, and in the RP formulation...
February 22, 2023: Drugs in R&D
Daniela R Junqueira, Dimitri Bennett, Susanna Y Huh, Kyle Fahrbach, Binod Neupane, Marissa Betts
BACKGROUND: Dopamine antagonists are the main pharmacological options to treat gastroparesis. The aim of this study was to conduct a systematic literature review (SLR) to evaluate the profile of adverse events (AEs) of dopamine antagonists used in the treatment of children and adults with gastroparesis. METHODS: We searched EMBASE and MEDLINE up to March 25, 2021, for relevant clinical trials and observational studies. We conducted a proportional meta-analysis to estimate the pooled occurrence of AEs (%), with 95% confidence interval (CI), from arm-level data across studies and the comparative occurrence of AEs from placebo-controlled clinical trials (odds ratio [OR] with 95% CI)...
February 7, 2023: Drugs in R&D
William J Foster, Andrew L Strahs, Kent W Small, James M Roach
BACKGROUND AND OBJECTIVE: Palovarotene, a selective retinoic acid receptor γ agonist, is under investigation for the treatment of dry eye disease. This study aimed to determine the ocular and systemic safety, tolerability and pharmacokinetics of palovarotene ophthalmic solution (PVO-OS) in healthy adults. METHODS: This was a randomised, vehicle-controlled phase I study (NCT04762355; retrospectively registered). Participants received either PVO-OS (at 0.025, 0...
December 21, 2022: Drugs in R&D
Na Zhang, Hong-Xia Zhang, Yu-Wei Li, Yuan Li
BACKGROUND AND OBJECTIVE: Systemic lupus erythematosus (SLE) is an autoimmune disease, with hydroxychloroquine being the main therapeutic agent for the treatment of SLE. This research explored the effects of hydroxychloroquine combined with low-dose aspirin on maternal and infant outcomes and cytokines of pregnant women with SLE. METHODS: Ninety pregnant women with SLE were divided into the hydroxychloroquine (HCQ) group (45 cases) and the hydroxychloroquine combined with low-dose aspirin (HCQASP) group (45 cases) by random number table...
November 30, 2022: Drugs in R&D
Diana Dubrall, Bernhardt Sachs, Klaus Kraywinkel, Maike Schulz, Matthias Schmid, Wilma Fischer-Barth, Jens Bate
INTRODUCTION: In Germany, incidence rates of basal cell (BCC) and squamous cell carcinoma (SCC) rose significantly from 1998 to 2010. Ultraviolet (UV) light exposure, immunosuppressants and drugs with photosensitising potential are known to increase the risk to develop BCC and SCC. The aim of our study was to analyse the adverse drug reaction (ADR) reports from Germany referring to BCC and SCC and to compare them to BCC and SCC occurring in the general population. METHODS: We analysed all validated spontaneous ADR reports referring to BCC (n = 191) and SCC (n = 75) from Germany contained in the European ADR database EudraVigilance prior to 6 March 2019...
November 19, 2022: Drugs in R&D
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
BACKGROUND: Cloperastine is a pivotal antibechic widely prescribed to treat cough caused by respiratory diseases. The present trial evaluated the pharmacokinetics (PK), bioequivalence (BE) and safety effects of the generic test (T) tablet of cloperastine after single-dose administration of cloperastine, compared with the original reference (R) tablet of cloperastine. OBJECTIVE: The purpose of this trial was to compare the PK, BE and safety of a test 10 mg versus the reference 10 mg formulation of cloperastine under fasting and postprandial conditions in healthy Chinese volunteers...
November 11, 2022: Drugs in R&D
Chaoying Hu, Dan Gao, Dandan Li, Dongli Zhou, Lan Zhang
OBJECTIVE: We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured Glucophage® immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. METHODS: This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France)...
October 20, 2022: Drugs in R&D
Christopher Hawthorne, Martin Shaw, Ruaraidh Campbell, Nicholas Sutcliffe, Shiona McKelvie, Stefan Schraag
BACKGROUND AND OBJECTIVE: Pharmacokinetic or pharmacokinetic-pharmacodynamic models have been instrumental in facilitating the clinical use of propofol in target-controlled infusion systems in anaesthetic practice. There has been debate over which model should be recommended for practice. The covariates model is an updated pharmacokinetic model for propofol. The aim of this study was to prospectively validate this model in an adult population. METHODS: Twenty-nine patients were included, with a range of ages to assess model performance in younger and older individuals...
October 7, 2022: Drugs in R&D
Shuangyan Yang, Junfeng Zhang, Dan Chen, Jie Ding, Yanhong Zhang, Lili Song
BACKGROUND AND OBJECTIVES: Aspirin is a common drug for the treatment of pre-eclampsia. We aimed to explore whether quercetin as a supplement to aspirin could enhance the therapeutic outcome in pre-eclampsia rat models. We further aimed to evaluate the nucleotide-binding oligomerization domain-like receptor family, pyrin domain containing 3 (NLRP3) inflammasome as a potential pre-eclampsia-related molecular mechanism, which can be affected by quercetin treatment. METHODS: Rat pre-eclampsia models were established using an intravenous lipopolysaccharide injection after gestation...
September 22, 2022: Drugs in R&D
Ryohei Ono, Kazutaka Nishimura, Hidehisa Takahashi, Yasuhiko Hori, Kenichi Fukushima, Yoshio Kobayashi
BACKGROUND: Chromogenic anti-factor Xa activity (AXA) assay is used to measure the pharmacodynamics of factor Xa inhibitors, including edoxaban. Although AXA concentrations in patients with non-valvular atrial fibrillation using edoxaban have been reported, the impact of renal function on AXA concentrations with edoxaban use in patients with non-valvular atrial fibrillation has not been fully assessed. METHODS: Trough and peak AXA concentrations were measured in 93 patients with non-valvular atrial fibrillation taking edoxaban (73...
September 14, 2022: Drugs in R&D
Roman Borišek, André Mischo, Ida Šmid
AIM: The purpose of this study was to evaluate the extended physicochemical and biological stability of Sandoz Rixathon®/Riximyo® (SDZ-RTX) after exposure to out-of-fridge (OOF) conditions. MATERIALS AND METHODS: The impact of the short-term temperature excursion on stability parameters of SDZ-RTX was simulated by subsequently exposing the three batches of SDZ-RTX (100 and 500 mg) to OOF conditions, (I) 25 ± 2 °C/60 ± 5% relative humidity (RH) and (II) 30 ± 2 °C/65 ± 5% RH, for up to 21 days after more than the claimed 36-month shelf-life storage in long-term conditions (5 ± 3 °C)...
September 2022: Drugs in R&D
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
BACKGROUND AND OBJECTIVES: In young people aged < 50 years, cervical artery dissection (CeAD) is among the most common causes of stroke. Currently, there is no consensus regarding the safest and most effective antithrombotic treatment for CeAD. We aimed to synthesize concrete evidence from studies that compared the efficacy and safety of antiplatelet (AP) versus anticoagulant (AC) therapies for CeAD. METHODS: We searched major electronic databases/search engines from inception till September 2021...
September 2022: Drugs in R&D
Angela Genge, Benjamin Rix Brooks, Björn Oskarsson, Alexander Kalin, Ming Ji, Stephen Apple, Laura Bower
BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neuromuscular disease with no curative therapies. Edaravone (Radicava® ) (Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan), approved in the United States (US) for ALS in adults in 2017, was shown in a clinical trial to slow the rate of physical functional decline in ALS and is administered intravenously. The aim of this paper is to summarize the observed safety profile from real-world patient use during the first 3 years of edaravone availability in the US...
September 2022: Drugs in R&D
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
No abstract text is available yet for this article.
August 25, 2022: Drugs in R&D
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 with mild, moderate, or severe COVID-19. A variety of drugs and drug classes were selected, including heparin, the monoclonal antibody crizanlizumab, sodium-glucose cotransporter-2 inhibitors, and purinergic signaling receptor Y12 inhibitors...
August 24, 2022: Drugs in R&D
Venanzio Vella, Johannes E Schmidt, Giulia Luna Cilio, Iris De Ryck, Audino Podda, Valentino Conti, Joachim Auerbach
No abstract text is available yet for this article.
August 22, 2022: Drugs in R&D
Maki Umemiya, Yoshihide Inayama, Eiji Nakatani, Kenta Ito, Mitsuru Tsuji, Teruki Yoshida, Sae Yu, Rei Gou, Naoki Horikawa, Hirohiko Tani, Kenzo Kosaka
BACKGROUND AND OBJECTIVES: Irinotecan sometimes causes lethal septic shock but the risk factors remain unclear. This retrospective case-control study explored the potential risk factors for septic shock following irinotecan treatment. METHODS: All women who received irinotecan-containing chemotherapy for gynecologic malignancies at Shizuoka General Hospital from October 2014 to September 2020 were investigated. The clinical backgrounds and blood test results of those who developed septic shock after irinotecan-containing chemotherapy were compared with those who did not...
August 20, 2022: Drugs in R&D
Hideki Arai, Shinichiro Ueda, Kazutaka Uchida, Fumihiro Sakakibara, Norito Kinjo, Mari Nezu, Takeshi Morimoto
No abstract text is available yet for this article.
August 18, 2022: Drugs in R&D
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
BACKGROUND: The efficacy and safety of upadacitinib in atopic dermatitis (AD) have been defined in clinical trials, but no real-world data are currently available. We aimed to assess the safety and effectiveness of upadacitinib in a real-world AD patient cohort that mostly included patients who failed the available systemic therapies, including dupilumab. METHODS: Prospective cohort study collecting data on upadacitinib-treated AD adult patients completing at least 16 weeks of therapy...
August 3, 2022: Drugs in R&D
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