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Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies
The U.S. Food and Drug Administration and European Commission have developed successful orphan drug legislation to promote the research, development,...
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Hierarchical Assessment of the Structural Similarity of Pharmacologically Active Compounds
Anew method for assessing the structural similarity of pharmacologically active substances based on a hierarchical description of the chemical...
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Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended
ObjectiveThe Institute for Safe Medication Practices (ISMP) and the United States Food and Drug Administration (FDA) disseminated widely used lists...
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Development of a Method for Assay of Flavonoids and Chlorhexidine in Medicinal Wound-Healing Pencil Formulations
Amethod for selective assay of flavonoids and chlorhexidine bigluconate in medicinal wound-healing pencils was developed using differential...
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Chemodiversity and Trypanocidal Activity of the Volatile Oils of Tropical Black Sage
Tropical black sage ( Varronia curassavica Jacq., Cordiaceae) is a species native to ecosystems subject to strong anthropic action, and thus is at...
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Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka
BackgroundLook-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create...
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Assessing the severity of medication administration errors identified in an observational study using a valid and reliable method
BackgroundEpidemiological data on medication errors severity are scarce. The assessment of the prevalence and severity of medication errors may be...
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Are there sex differences in oxytocin and vasopressin V1a receptors ligand binding affinities?
BackgroundThere is substantial evidence for sex differences in the functioning of one of the most common receptor systems; G protein-coupled...
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Strength-Dependent and Strength-Independent Dissolution Patterns of Poorly-Soluble Drugs. Case Example: Valsartan
This study aims to investigate the strength-dependent dissolution pattern of two-dose strengths of valsartan: the low-dose strength of 80 mg and...
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Evaluation of Quality Control Parameters of Expired and Non-Expired Tablets Containing Poorly Water-Soluble Drug (Clopidogrel) with Emphasis on Dissolution Stability
Clopidogrel is an antiplatelet drug available as tablet dosage form (75 mg) alone and in combination with other drugs like aspirin. It is a BCS class...
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Isoflavone-Rich Extract of Trifolium resupinatum: Anti-obesity Attributes with In Silico Investigation of Its Constituents
Trifolium resupinatum L., Fabaceae, aqueous methanol leaf extract was selected to mitigate some obesity-associated risk factors to validate the...
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Oritavancin (KIMYRSA™) in acute bacterial skin and skin structure infections: a profile of its use in the USA
Oritavancin, a long-acting lipoglycopeptide, is the first single-dose intravenous (IV) antibacterial therapy approved in the USA for the treatment of...
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The essential role of TAZ in normal tissue homeostasis
Transcriptional coactivator with PDZ-binding motif (TAZ) has been extensively characterized in organ development, tissue regeneration, and tumor...
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Cutting Through the “Gray Area”: An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research
The advent of clustered regularly interspaced short palindromic repeats (CRISPR) technology has quickly ushered in a new era of gene editing and...
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Knowledge and perception of biosimilars in ambulatory care: a survey among Belgian community pharmacists and physicians
BackgroundWith the approval of biosimilars for subcutaneously administered products, such as adalimumab, etanercept and insulin, biosimilars become...
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Advancing medical affair capabilities and insight generation through machine learning techniques
BackgroundPharmaceutical companies are increasingly leveraging machine learning techniques to optimize healthcare research, drug development, and...
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Expert Commentary: Diverse Meanings of Regulatory “Convergence”
The term regulatory “convergence” is apparently given many meanings in the field of medical products. Originally defined as a process of making...
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Bayesian Design for Pediatric Clinical Trials with Binary Endpoints When Borrowing Historical Information of Treatment Effect
The efficacy evaluation in pediatric population is an important component of drug development and is generally required by the regulatory agencies....
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Weighted gene co-expression network analysis for hub genes in colorectal cancer
BackgroundThis study is designed to explore hub genes participating in colorectal cancer (CRC) development through weighted gene co-expression...
