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13 Cards in this Set
- Front
- Back
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Drug development overseen by...
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- FDA
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The four steps of drug development
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1. Preclinical animal studies
2. Investigational New Drug Application (INDA) 3. Clinical testing (Phases I-III) 4. New Drug Application (to test the new drug) |
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Preclinical testing
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- Preclinical testing (1-3 yrs)
- Animal testing for toxic effects, side effects, addiction potential, and teratogenic properties |
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Therapeutic Index (TI)
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- TI; margin of safety
Drug A Drug B mg mg 50---toxic effect---LD50 50 40 40 30 30 20 20---toxic effect ---LD50 10---------------------ED50 10----------------------ED50 0 0 50 % 10= TI 5 20 % 10= TI 2 * Drug B more lethal * "narrow therapeutic drug" * check for s/s toxicity |
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Investigational Drug Application
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- In people
- Approved by the FDA - Clinical trials in humans |
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Clinical trials (best studies)
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- Double-blinded (do not know which is the placebo)
- Placebo controlled |
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Phase I
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- Phase I (1 1/2 yrs)
- Healthy volunteers - Informed consent - Safety, effectiveness, dosage range, therapeutic use - Phamacokinetics comes from young, healthy people |
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Phase II
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- Phase II (2 yrs)
- Tested on ill volunteers; those who have the condition that we want to treat - For example: patients with high b/p - Phase II checks for side effects |
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Phase III
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- Phase III (3 1/2 yrs)
- Large # of ill volunteers - Manner identical to anticipated use - Rare side effects, risks, safety, and effectiveness |
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Phase III Completion
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- Application for new drug
- FDA review for about 2 yrs |
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Phase IV (optional)
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- Phase IV optional
- Optional clinical trial drive by the drug company - Comparison studies with other drugs used in the treatment for the same condition |
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Approval
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- Trade/Brand Name
- National Drug Code (NDC) - Drug to market - Mfg. exclusive rights for about 20 yrs - Post marketing surveillance; monitor adverse, dangerous reactions - Prescribers report adverse effects to FDA |
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Drug Marketing and Advertising
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- Marketing to prescribers
- Marketing to consumers - TV ads - Magazine ads - Cost of meds increased 79% in less than 10 yrs |
