Human Genetics
The biological codes in cells that determine an organism's distinct inherited features.
What are human genetics?
The biochemically active components that exert the desired effects.
What are active ingredients?
The process by which a manufacturer submits research results from animal studies to the FDA to gain approval to gather data and test a new drug on humans.
What is an investigational new drug (IND) application?
The process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
What is a new drug application (NDA)?
Drugs that are meant for self-limited conditions (conditions that could resolve themselves on their own).
What are OTC (over-the-counter) drugs?
Carried in the center of each cell and is made up of atomic matter that carries codes to direct the growth of the cell.
What is deoxyribonucleic acid (DNA)?
An ingredient that has little or not physiological effect.
What is an inert ingredient?
Comprised of scientists and practitioners from various disciplines and consumers that review, approve and monitor all medical research involving humans, in a university or hospital.
What is the Institutional Review Board (IRB)?
Takes a year or longer.
What is the drug approval process?
Submitting a new drug application with a specific dose and indication results in this.
What is an approval to bring an OTC drug to market?
What is a gene?
Penicillin, insulin, Taxol, streotomycin, vincristine, limulus amebocyte lysate, armour thyroid, and somatotropin.
What are drugs derived from natural sources?
A document that states the purpose and risks of research in easily understandable terms.
What is an informed consent form?
The cost of developing a new drug.
These things are necessary for OTC drugs as patients may have no contact with a pharmacist or typed instructions.
What is adequate product labeling, and easy to understand terms?
Drugs designed by manipulating genes in living substances to affect the genes in certain patient cells.
What are genetically engineered drugs?
Synthetic, synthesized, semisynthetic, and biogenetically engineered drugs.
What are classification of drugs created in laboratories?
Three phases of human clinical studies that are part of the drug approval process.
What are gather, evaluate and assess?
The time it takes a new medication to move from the laboratory to the pharmacy shelf.
What is 15 -20 years?
Drug Facts box, Uses box, warnings and directions, and toll free number for adverse effects, inert and active ingredients.
What is what is required on the labels of OTC drugs?
The field of study that combines the sciences of biology, chemistry, and immunology to produce unique synthetic drugs with specific therapeutic effects.
What is biotechnology?
This crustacean is captured each spring (over 600,000) with 30% of their blue blood being donated to be used to reveal and isolate certain bacteria and help clot hemophiliac blood.
What is the crab?
This drug saved thousands of children from disfigurement and handicaps in the 1960's.
What is thalidomide?
The postmarketing safety system is also referred to as this.
What is Phase 4?
This agency regulates OTC drugs.
What is the FDA?