PRELIM 01 - Introduction and Drug Discovery Flashcards
The study of the source, physical and chemical properties, compounding, physiological actions, absorption, fate, and excretion, and therapeutic uses of drugs
Pharmacology
Substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
Drug
The branch of pharmacology that studies the kinetics of drug absorption, distribution, metabolism and excretion
Pharmacokinetics
The branch of pharmacology that studies the biochemical, cellular, and physiological effects of drugs and their mechanisms of action
Pharmacodynamics
The branch of pharmacology that studies the undesirable effects of drugs on living systems, from individual cells to humans to complex ecosystems
Toxicology
Screening that involves assays at the molecular, cellular, organ system, and whole animal levels
Drug screening
Refers to a leading candidate for a successful new drug
Lead compound
Testing that involves safety and toxicity testing
Preclinical testing
Usually two species, two routes (Type of test)
Acute toxicity
Three doses, two species (Type of test)
Subacute/Subchronic toxicity
Rodent and at least one nonrodent species for ≥6 months (Type of test)
Chronic toxicity
Two species, usually one rodent and rabbit (Type of test)
Effect on reproductive performance
Two years, two species (Type of test)
Carcinogenic potential
Test effects on genetic stability and mutations in bacteria (Type of test)
Mutagenic potential
Maximum dose at which a specified toxic effect is not seen
No-effect dose
Smallest dose observed to kill any experimental animal
Minimum lethal dose
Dose that kills 50% of animals in a test group
Median lethal dose (LD50)
Is filed with the FDA before clinical testing
Investigational new drug (IND)
Involves 20-100 healthy subjects; to determine safety and pharmacokinetic profile (Phases of drug development)
Phase I
Involves 100-200 subjects with target disease; to determine efficacy; has the highest rate of drug failures (Phases of drug development)
Phase II
Only __________% of innovative drugs move on to phase III
25%
Involves thousands of subjects with target disease; to determine efficacy and safety (Phases of drug development)
Phase III
Design of Phase III of drug development
Randomized controlled trial (RCT)
Refers to random distribution of subjects between experimental and control group; happens in Phase III of drug development
Randomization
Subjects do not know the intervention received; happens in Phase III of drug development
Single-blind
Subjects and investigators do not know the intervention received; happens in Phase III of drug development
Double-blind
Is filed with the FDA before marketing; must contain full reports of all preclinical and clinical data
New drug application (NDA)
Involves post-marketing surveillance; monitoring the safety of the new drug (Phases of drug development)
Phase IV
Allows one pharmaceutical company to have exclusive right to market the drug; expires 20 years after application
Patent
After expiration of patent, other pharmaceutical companies can file __________ to market generic products
Abbreviated new drug application (ANDA)
Drug that serves as treatment for rare diseases; is difficult to research and has low marketing value
Orphan drugs
Amendment that provides incentives for the development of drugs for treatment of a rare disease or condition
Orphan drug amendment of 1983 (USA)
