MODULE 1 Flashcards
Initiated to define physical and chemical properties of agent
Preformulation studies
Follow to develop the initial features of the proposed pharmaceutical products.
Formulation studies
Examples of Pre-clinical
Cell culture
While animal
If the drug demonstrate adequate safety in initial human studies, it is termed what?
Phase I
Undertaken to assess safety and efficacy
Phase ll and lll
Seeks approval to the market
NDA
Summary of the entire drug development process
Package insert
Often are sought for orphan drugs
Treatment IND
Targeted for small number of patients who have rare conditions or disease.
Orphan drugs
Used to gain approval to the market
ANDA
Prototype chemical compound
Lead compound
H2 antagonist from pioneer drug
Cimetidine
This drug is a Large series of anti-anxeity drugs derived from benzodiazepine structure and innovator drug.
Chlordiazepoxide (Librium)
Originally developed to treat Benign Prostatic hyperplasia (BPH)
Finasteride (Proscar)
Approved to treat male pattern baldness
Propecia
Term used to describe a compound thy requires metabolic biotransformation
Prodrug
Their works leads to determination of whether a chemical agent possesses adequate features of safety and pursue as prospective new drug.
Scientist
Develop studies that may be conducted outside the living body.
Scientists
Used increasingly to screen for toxicity before whole-animal testing.
Cell culture
Also known as small scale production
Pilot plant
Determine dose response and dose ranging often called what?
Phase 2a
Used to gather supplemental information that may support labeling request.
Phase 3b studies
Tranquilizer and hypotensive agent
Reserpine
First scientifically investigated and is useful for treatment of diabetes mellitus
Periwinkle (vinca rosea)
