Safety plasma protein binding

Plasma protein binding has also been taken into account in setting safety margins [30] and target concentrations [31] for antifungal agents. 

Impact of Plasma Protein Binding on PK, Exposure, Safety Margins, Potency Screens and Drug-Drug Interaction... 

Rosenthal AE (1967) A graphic method for the determination and presentation of binding parameters in a complex system. Analytical Biochemistry 20 525-532 Sansom LN, Evans AM (1995) What is the True Clinical Significance of Plasma Protein Binding Displacement Interactions Drug Safety 12(4) 227—233 Scatchard G (1949) The attractions of protein for small molecules and ions. New York Academic of Sciences 51 660-692... 

Lactation Sulfonamides are excreted in breast milk. In newborns, they compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Children The safety and efficacy of sulfasalazine in pediatric patients younger than 2 years of age with ulcerative colitis have not been established. 

The third section of an application usually contains clinical data. This may take the form of pharmacokinetic studies in both animals and human volunteers. Measurements such as plasma levels, area under the curve, protein binding, etc. are compared with data from other manufacturer s products and conclusions are reached about the safety, quality and efficacy of the new product. 

Lactation — The moderate protein-binding profile of FLB suggests that the infant may have measurable plasma concentrations if breast-fed. In addition, safety issues regarding rare aplastic anemia associated with FLB in patients with epilepsy may increase the theoretical risks of breastfeeding. 

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