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Why is it important to check for bacterial endotoxins in drug development?

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  Impurities that need to be controlled may be generated during the production and standard storage of drugs according to established processes, and these impurities may impact the activity and safety of the drug itself. They may also cause adverse reactions in the clinical use of the drug. Therefore, impurity analysis is crucial in pharmaceutical research to drug development . Bacterial endotoxin is a process-related impurity, one of the headache impurities in the purification of proteins, nucleic acids, polysaccharides, and other biological macromolecules, which are widely present in reagent consumables and samples. It is a significant source of contamination in biomedical tests and pharmaceutical products, and the inspection of bacterial endotoxin has become one of the critical testing items for drug quality control. Bacterial endotoxin is a complex formed by lipopolysaccharide of the cell wall of Gram-negative bacteria, and a variety of trace proteins, which are released with bio

Salt formation: an effective means to improve the physical and chemical properties of drug molecules and enhance the druggability of drugs

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  In drug development, drug forming research , including pharmacodynamics, pharmacokinetics, and early safety evaluation of drugs, is required to determine whether the active compound has the potential to be developed into a pill. The drug-forming properties of drugs are also an essential part of the drug-forming evaluation, and salt formation is one of the effective means to improve the physicochemical properties of drug molecules and enhance drug-forming properties.   Many drugs are salts of organic acids or bases. The salt formation can make some oily organic acids or organic bases solid, which is conducive to preparing concrete dosage forms. Moreover, the salt formation of drugs increases the water solubility, which is conducive to preparing some aqueous dosage forms, such as water injection and oral liquid. The salt formation process is often a purification process, which removes the impurities mixed in the drug that cannot become salt, etc. So what are the benefits of salt fo

Inventory of the five significant mechanisms of nephrotoxic drug effects

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 The kidney is the main organ for the metabolism and excretion of various drugs, from minor to common anti-cold drugs, antibiotics, antivirals, and significant to anti-tumor drugs, all of which may cause kidney damage. In drug safety evaluation studies, the study of drug nephrotoxicity is a critical element. The causes of kidney susceptibility to drug damage include physiological function aspects, anatomical structure and composition of material components, blood supply, and drug metabolism. The mechanism of nephrotoxic action of drugs can be divided into five major types according to the mode of action of renal damage of drugs. Drug-induced kidney damage can be called drug-related kidney damage, which refers to the adverse reactions of the kidney to therapeutic doses of drugs and toxic reactions due to drug overdose or irrational application. For example, drug-induced acute tubular necrosis can manifest as irritable thirst, polyhydramnios, polyuria, and other non-oliguric symptoms, an

The Significance of LD50 and ED50 in Drug Toxicology Studies

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  The LD50 and ED50 are vital to research indicators in drug toxicity studies to assess drug safety and efficacy. Toxicology is a science that studies the effects and mechanisms of damage to biological systems and ecosystems by exogenous factors such as chemical, physical and biological factors, as well as the prevention, diagnosis, and treatment of poisoning.  Drug toxicology is the science of studying the damaging effects of drugs on the organism. LD50 and ED50 are indicators of toxicology research, and understanding these parameters is crucial to ensure the safety and efficacy of drugs and regulatory compliance. This blog will provide a comprehensive overview of LD50 and ED50, their significance in drug toxicology, and how they are measured and interpreted. LD50 refers to the dose at which half of the test animal samples die, while ED50 is the dose at which half are effective. The safety index of a drug TI = LD50/ ED50. The higher the value, the safer it is. The therapeutic ind