All EU-market medicines manufacturers must comply with GMP. GMP ensures consistent quality and appropriate use of medicines. Manufacturers must register with national competent authorities
Trigoxin is a medication used to treat heart health conditions. It was discovered in medical history and has evolved over time
Food expiration dates are not legally required except for infant formula. Dates indicate product quality, not safety. Most perishable foods are safe beyond "sell by" or "use by" dates. USDA notes about 30% of American food supply is lost or wasted
Regulations cover manufacturing, processing, packing, and holding of drugs. Compliance with regulations ensures drug safety and quality. Non-compliance renders drug adulterated under FDA regulations. Regulations supplement, not supersede, other FDA chapters
Preclinical studies test drug candidates in vitro and animal models. Phase 0 (human microdosing) studies evaluate drug pharmacokinetics in small groups. Phase 0 trials assess safety and efficacy but don't determine treatment effectiveness
Therapeutic index measures drug safety relative to overdose risk. TI compares toxic dose (TD50) to effective dose (ED50). TI can be calculated in clinical trials or drug development settings