mjl1717
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Can anyone explain the steps taken to approve a drug in the U.S.?
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| mani
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it is given in kaplan pharma. i m summarizing whatever i remember:
1. preclinical studies, usually done on animals regarding:
a. toxicity with acute aubacute and chronic exposure
b. carcinogenic and mutagenic potential
c. effects on reproduction
d. effectiveness of drug if animal model of human dis is available
2. clinical studies
a. is the drug safe?? done on a small number of volunteers not having dis
b. is it effective? done on 100 or more pts with target dis. single n double blind trials
c. how effective it is? common side effects?
d. marketing of drug and follow up for uncommon side effects
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| Ahab
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Preclinical, lead compound is found, analysed and if there is a disease phenotype in animals that compare to humans animal testing is carried out. The lace of a animal models of CNS disorders such as depression is one reason why pharmacological solutions are more difficult to come by (fortiutous discovery)
Stage 1. Is it safe?
Compound is tested on a small group (<100) of HEALTHY individuals and drug is analysed for safety, pharmokinetics and looked for any side effects.
Stage 2. Does it work?
Drug is tested on a small group (around 200) of patients WITH the disease and the drug is tested to determine efficacy against the disease process it was designed for, if it is found to work it proceeds to the next stage.
Stage 3. Does it work double blind?
Drug is compared with placebo or standard tx in a group of 2000 or so and attempts to discover if it is better or worse than currently available treatment options.
Patients are randomised and testing is carried out under double blind standards. If the drug is better than all findings are forwarded to the FDA for evaluation and approval for market in the US (they are not a worldwide regulating body, although the clout of the FDA means that many smaller countries hold off on giving approval before the FDA gives their verdict)
Stage 4. Postmarketing surveillance
Drug is sold and it may not be until now that they discover rare side effects of drugs (that occur in 1/10,000 etc)
There is a responsibility on the physicians part to report side effects to the pharmaceutical company at this stage
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| mjl1717
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Preclinical Studies-On animals two different species
Clinical Studies -On Humans
Phase 1-on a small group without target disease-{pharmacokinetics?}safe?
Phase 2-Evaluation of drug effectiveness on 100 or more pts with the
disease(compared with placebo and +control)
Phase 3-Increase the pts 10 fold or more to 1000 with the disease
usually double blind, [What are the common side effects.]******
Phase 4-New NDA application, post marketing surveillance of drug adverse
effects, may reveal Surprise toxicities and drug withdrawl!!
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