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Specialty: Drugs & Pharmacology
Management: Food and Drug Administration (FDA)
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Total 715 results found since Jan 2013.
Efficacy of Biologics in Patients with Allergic Severe Asthma, Overall and by Blood Eosinophil Count: A Literature Review
This study describes published annualized asthma exacerbation rate (AAER) reductions from RCTs in patients with allergic severe asthma, overall and by baseline BEC category. A literature search was performed to identify published phase 3 RCT data of US Food and Drug Administration-approved biologics for severe asthma in patients with severe, uncontrolled asthma and confirmed sensitization to perennial aeroallergens. Analyses focused on AAER reduction versus placebo in the overall population and/or in those with an elevated or low BEC at baseline or screening. Baseline serum total immunoglobulin E levels varied between RCT ...
Source: Advances in Therapy - September 12, 2023 Category: Drugs & Pharmacology Source Type: research
Evidence based optimal dosing of intravenous artesunate in children with severe falciparum malaria
In this study, we performed population pharmacokinetic modeling of plasma concentration data from 80 children with severe falciparum malaria in the Democratic Republic of Congo who were given 2.4 mg/kg of artesunate intravenously. Bayesian hierarchical modeling and a two-compartment parent drug-metabolite pharmacokinetic model for artesunate were used to describe the population pharmacokinetics of artesunate and its main biologically active metabolite dihydroartemisinin. We then generated a virtual population representative of the target population in which the drug is used and simulated the total first-dose exposures. Our...
Source: Clinical Pharmacology and Therapeutics - September 4, 2023 Category: Drugs & Pharmacology Authors: Ali Haghiri David J Price Phoebe Fitzpatrick Saber Dini Megha Rajasekhar Caterina Fanello Joel Tarning James Watson Nicholas J White Julie A Simpson Source Type: research
Recombinant Antibody Fragments for Neurological Disorders: An Update
Curr Neuropharmacol. 2023 Aug 30. doi: 10.2174/1570159X21666230830142554. Online ahead of print.ABSTRACTRecombinant antibody fragments are promising alternatives to full-length immunoglobulins, creating big opportunities for the pharmaceutical industry. Nowadays, antibody fragments such as antigen-binding fragments (Fab), single-chain fragment variable (scFv), single-domain antibodies (sdAbs), and bispecific antibodies (bsAbs) are being evaluated as diagnostics or therapeutics in pre-clinical models and in clinical trials. Immunotherapy approaches, including passive transfer of protective antibodies, have shown therapeutic...
Source: Current Neuropharmacology - August 30, 2023 Category: Drugs & Pharmacology Authors: Karen Manoutcharian Goar Gevorkian Source Type: research
Bleeding Complications in Vancomycin-Induced Thrombocytopenia: A Real-World Postmarketing Pharmacovigilance Analysis
The objective of this study is to assess the potential relevance between vancomycin and bleeding complications in thrombocytopenia.METHODS: This is a real-world pharmacovigilance study conducted in October 2022 using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a disproportional analysis to assess the risk of bleeding complications in vancomycin-induced thrombocytopenia by calculating reporting odds ratios (RORs) and information components (ICs), with a weak signal defined as a lower limit of the IC 95% CI of 0 to 1.5, a middle signal defined as a lower limit of the IC 9...
Source: Clinical Therapeutics - August 28, 2023 Category: Drugs & Pharmacology Authors: Hui Yang Ying Zhang Xin Feng Zhuoling An Source Type: research
Investigation of immunogenicity assessment of biosimilar monoclonal antibodies in the United States
Clin Pharmacol Ther. 2023 Aug 27. doi: 10.1002/cpt.3033. Online ahead of print.ABSTRACTImmunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. We aimed to investigate the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research, United States Food and Drug Administration (USFDA) as of March 13, 2022, co...
Source: Clinical Pharmacology and Therapeutics - August 27, 2023 Category: Drugs & Pharmacology Authors: Ching-An Cheng Ai-Lei Jiang Yu-Ru Liu Lin-Chau Chang Source Type: research
United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism
Expert Opin Drug Saf. 2023 Aug 18:1-6. doi: 10.1080/14740338.2023.2245748. Online ahead of print.ABSTRACTINTRODUCTION: Nuclear reactor incidents and bioterrorism outbreaks are concerning public health disasters. Little is known about US Food and Drug Administration (FDA)-approved agents that can mitigate consequences of these events. We review FDA data supporting regulatory approvals of these agents.AREAS COVERED: We reviewed pharmaceutical products approved to treat Hematopoietic Acute Radiation Syndrome (H-ARS) and to treat or prevent pulmonary infections following Bacillus anthracis (anthrax) exposure. Four drugs were a...
Source: Expert Opinion on Drug Safety - August 18, 2023 Category: Drugs & Pharmacology Authors: Charles L Bennett Peter Georgantopoulos Robert Peter Gale Kevin Knopf William J Hrushesky Chadi Nabhan James O Armitage Source Type: research
LC-MS/MS Investigation of Nitrosamine Impurities in Certain Sartan Group Medicinal Products Available in Istanbul, T ürkiye
Ann Pharm Fr. 2023 Aug 9:S0003-4509(23)00079-2. doi: 10.1016/j.pharma.2023.08.002. Online ahead of print.ABSTRACTNitrosamines (NAs) are molecules that include the nitroso functional group. In 2018, the US Food and Drug Administration (FDA) received its first report of NAs in pharmaceuticals. The fact that NA impurities are likely human carcinogens is relevant to these compounds. Furthermore, prolonged exposure to NA contaminants above safe limits may raise the risk of cancer. The goal of this article was to assess the amounts of six different NAs in sartan group medicines purchased from formal pharmacies in Istanbul, Türk...
Source: Annales Pharmaceutiques Francaises - August 11, 2023 Category: Drugs & Pharmacology Authors: Tuna Öncü Bayram Y üksel Emrullah Binay Nilg ün Şen Source Type: research
