new drug development and approval process Flashcards
what are the sources of drugs
Natural sources
synthesized in laboratory
processes of biotechnology
certain major contributions to modern drug therapy may be attributed to the
successful conversion of botanic folklore remedies into modern wonder drugs
tranquilizer, hypotensive agent
reserpine/rauwolfia serpentina
diabetes mellitus
periwinkle or vinca rosea
plants extracts of V. rosea yield 2 potent drugs for certain types of cancer (leukemia, hodgkin disease)
vinblastine
vincristine
ovarian cancer
pacific yew tree
mumps and influenza vaccines
fluid of chick embryo
rich source of estrogen
urine of pregnant mares
poliomyelitis vaccines
renal monkey tissue
rubella (german measles)
duck embryo
new vaccines for diseases aids and cancer
cell and tissue cultures
smallpox vaccines
skin of bovine calves inoculated with vaccinia virus
requires metabolic biotransformation after administration
prodrug
science concerned with drugs, their sources, appearance, chemistry, actions and uses.
pharmacology
this extent and rate of drug absorption from various routes of administration
absorption
the rate of drug distribution of the drug through the body and the site or sites
distribution
the rate, primary and secondary sites, the mechanism of the drug’s metabolism
metabolism
the proportion of administered dose eliminated from the body
excretion/elimination
drug substance administered by any route
drug’s solubility
a measure of its distribution in a lipophilic - hydrophilic phase system
partition coefficient
speed at which drug substance dissolves in a medium is called
dissolution rate
reducing the particle size and increasing the powder fineness
physical form
the chemical and stability of drug substance are critical to prepare a successful pharmaceutical product
stability
pre-formulation studies
drug’s solubility
partition coefficient
dissolution rate
physical form
stability
- healthy volunteers
- 20 to 100 subjects
- initial dose of drug is low
- greater dose until some evidences of the drug’s effect
- determine the human pharmacology
phase 1
- evaluate the effectiveness of a drug in patients with the condition.
- uses patients as subjects
- determine the pharmacokinetics of the drug
phase 2
- several hundred to several thousand patients in controlled and uncontrolled trials
- determine the usefulness of the drug
phase 3 and phase 4
a standard or comparator drug product
placebo drug
the patient is unaware of the agent administered
single blind studies
neither the patient nor the clinician is aware of the agent administered
double blind studies
neontal, pediatric, and geriatric patients
age
doses for certain drugs are based on ______
body weight
other important studies on women
sex
ability to endure the influence of drug
tolerance
effects of a drug may be modified by the prior
concomitant drug therapy
oral therapy in relation to meals
time
drugs administered intravenously enter the bloodstream
dosage form and route of administration
including the proprietary and nonproprietary names
description of the product
including a summary of actions of the drug in humans
clinical pharmacology
including the FDA-approved indications in the treatment
indications and usage
situations in which the drug should not be used
contraindications
including descriptions of serious adverse reactions and potential safety
warnings
including special care to be exercised by prescriber and patient in the use of the drug
precautions
including predictable and potential unpredictable undesired side effects
adverse reactions
including legal schedule if a controlled substance
drug abuse and dependence
including signs, symptoms and laboratory findings of acute overdosage
overdosage
stating the recommended usual dose
dosage and administration
drug product labeling
adverse reactions
clinical pharmacology
contraindications
description of the product
dosage and administration
drug abuse and dependence
indications and usage
precautions
warnings
overdosage
precautions
