drug development + safety

drug development starts with

discovery and characterization of a new drug and proceeding through clinical investigation leading to regulatory approval

new drugs are synthesized de novo

are isolated form a natural product, or some combo of both ( semisynthetic drugs)

before a drug can be given to humans, its pharmacological effects are investigated in

animal studies through preclinical studies

have to find out if drug has

harmful or beneficial effects on vital organ function

pre clinical studies discover the drug’s

mechanisms and therapeutic effects on target organ’s — pharmacokinetic properties

federal regulations require

extensive toxicity studies in animals

teratogenesis

the process by which a substance causes malformation or abnormal development of an embryo or fetus.

mutagenesis

the process by which a substance causes changes to the genetic material of an organism, potentially leading to mutations.

carcinogens

administer the drugs to rats and mice for their entire lives

FDA must approve application for

IND - investigational new drug before drug can be distributed

IND includes

complete description of the drug, results from pre clinical studies, description of the design + methods of proposed clinical studies

clinical trials phase I

determine pharmacokinetic properties + safety of an IND in healthy human subjects

clinical studies phase II

studies performed in human subjects with the particular dz the IND is targeting

clinical trials phase III

compare safety + efficacy of IND with that of another substance of tx approach

NDA includes

results of all pre-clinical + clinical studies as well as proposed labeling and clinical indications for the drug

non-FDA approved used are known as

unlabeled or “off-label” uses

once approved for marketing

post marketing surveillance is done (phase IV trials)

post marketing surveillance important for

detecting drug reactions that are uncommon and unlikely to be found during trials