Topic: фармацевтическое сырье лекарственные средства

The term affinity describes the tendency of a drug to bind to a receptor; efficacy (typically called intrinsic exercise) describes the ability of the drug-receptor complex to produce a physiological response. Collectively, the affinity and the efficacy of a drug determine its potency. Variations in efficacy decide whether a drug that binds to a receptor is categorised as an agonist or as an antagonist. Observe: This doc is reference material for investigators and other FDA personnel. The doc doe...

Manufacturers and product sponsors are subject to FDA laws and regulations. Current good manufacturing follow (CGMP) laws outline the minimal high quality requirements for manufacturing of medication, together with biologics, and are established to make sure that products are secure and effective for human use. See CGMP rules for medicine and chemistry, manufacturing and controls (CMC) and CGMP guidances for biologics. Related rules governing quality might be present in 21 Code of Federal Regula...