Using good clinical judgment, what questions should you ask yourself before prescribing a medication for a patient?
1. Is there a clear indication for drug therapy? 2. What drugs are effective in treating this disorder 3. What is the goal of therapy with this drug? 4. Under what conditions is it determined that a drug is not meeting the goal and a different therapy or drug should be tried 5. Are there unnecessary duplications with other drugs the patient is already taking 6. Would an OTC drug be just as useful as a prescription drug? 7. What about cost? 8. Where is the information to answer these questions?
§ Compound Selection
§ nGLP Tox Support
§ Compound enters development
§ IND-Enabling Studies
§ Drug Safety Review preIND (DSC)
o Clinical trials
§ Phase I
ú Phase II Support
§ Phase II
ú Phase III Support
ú Drug Safety Review EOPII (FDA)
§ Phase III
ú NDA Support
ú Drug Safety Review PreNDA (FDA)FDA review (NDA)
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