Before Trials
To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on pre-clinical data, typically from animal studies after P1, that shows the drug is safe enough to be tested in humans.
Often the "new" drugs that are submitted for approval include new molecular entities or old medications that have been chemically modified to elicit differential pharmacological effects or reduced side-effects.
Read more about this topic: New Drug Application
Famous quotes containing the word trials:
“Why, since man and woman were created for each other, had He made their desires so dissimilar? Why should one class of women be able to dwell in luxurious seclusion from the trials of life, while another class performed their loathsome tasks? Surely His wisdom had not decreed that one set of women should live in degradation and in the end should perish that others might live in security, preserve their frappeed chastity, and in the end be saved.”
—Madeleine [Blair], U.S. prostitute and “madam.” Madeleine, ch. 10 (1919)
“All trials are trials for one’s life, just as all sentences are sentences of death.”
—Oscar Wilde (1854–1900)