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Detection and Identification of an Unknown Impurity in Ephedrine HCl 5 mg/mL Cyclic Olefin Syringes: Formulation Development
An unknown impurity was detected in in-house prepared ephedrine hydrochloride (HCl) 5 mg/mL prefilled sterilized syringes when applying a...
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Impurity Profiling and Identification of 2,6-Diisopropylphenol by HPLC Method and Raman Spectroscopy Method
Identification of 2,6-diisopropylphenol by Raman spectroscopy using the TruScan Raman spectrum is validated by specificity test and robustness. HPLC...
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Use of In Silico Methods for Regulatory Toxicological Assessment of Pharmaceutical Impurities
The use of novel non-testing methodologies to support the toxicological assessment of drug impurities is having a growing impact in the regulatory...
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A Comprehensive Review on Assessment and Key Control Strategies for Impurities in Drug Development with a Special Emphasis on Post-marketing Surveillance
The presence of impurities is the primary cause of safety related drug product recall. Clinical data generated during the drug discovery process may...
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Drug Substance/Product Quality Analysis (Quality Assessment)
Multiple analytical studies are required on drug substances/products to maintain the quality during their lifecycle. One key regulatory change that...
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Scaffold-mediated switching of lymphoma metabolism in culture
BackgroundDiffuse large B cell lymphoma (DLBCL) is an aggressive subtype of non-Hodgkin lymphoma (NHL) and accounts for about a third of all NHL...
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Global Evidence on Assuring Quality of Medicines
Quality of medicine is a major challenge, especially in low- and middle-income countries. The factors contributing include weak regulatory capacity,...
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Pre-clinical Formulation Development of an in situ Meglumine Salt of AZD5991: A Novel Macrocyclic Mcl-1 Inhibitor
PurposeAZD5991 is a potent and selective macrocyclic inhibitor of Mcl-1 in clinical development. Develo** an intravenous solution formulation for...
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An Introduction to Safety Toxicology
To simply define the breadth and depth of knowledge that is encompassed by the discipline of toxicology is a very difficult task and is no easier...
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Application of Microfluidics in Drug Development
Microfluidics has become a transformative technology in drug development by offering new solutions that can potentially address some of the...
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Applications of Biotechnology in Pharmaceutical Product Analysis
The pharmaceutical sector is critical to supplying safe and effective pharmaceuticals to people all around the world. Pharmaceutical product...
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Biosimilars: Principles, Regulatory Framework, and Societal Aspects
A “generic” version of a biopharmaceutical may be introduced after patents and other exclusivity rights expire. However, the generic paradigm as it...
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Exploring Prognostic Gene Factors in Breast Cancer via Machine Learning
Breast cancer remains the most prevalent cancer in women. To date, its underlying molecular mechanisms have not been fully uncovered. The...
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Solanidine is a sensitive and specific dietary biomarker for CYP2D6 activity
BackgroundIndividual assessment of CYP enzyme activities can be challenging. Recently, the potato alkaloid solanidine was suggested as a biomarker...
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Gut metabolites predict Clostridioides difficile recurrence
BackgroundClostridioides difficile infection (CDI) is the most common hospital acquired infection in the USA, with recurrence rates > 15%. Although...
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A Review of Web-Based Metagenomics Platforms for Analysing Next-Generation Sequence Data
Metagenomics has now evolved as a promising technology for understanding the microbial population in the environment. By metagenomics, a number of...
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Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0
Heat stress studies have been conducted in support of develo** a heat-stable liquid solution of dalbavancin. The degradation products that form in...
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Forensic Drug Chemistry: Unravelling Evidence Through Scientific Analysis
Forensic drug chemistry plays a pivotal role in modern criminal investigations by utilising scientific methods to identify, analyse, and interpret...
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Use of Lhasa Limited Products for the In Silico Prediction of Drug Toxicity
Lhasa Limited have had a role in the in silico prediction of drug and other chemical toxicity for over 30 years. This role has always been...