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Additional resources for USMLE Road Map Pharmacology

Example text

However, there is also a little used, so-called Phase 0 stage of human testing in which greatly reduced, sub-therapeutic single doses of the potential drug are administered to a very few volunteers, 5–15, with the aim of studying the compound’s pharmacodynamics (how the drug works in the body) and/or pharmacokinetics (how the body processes the drug). Phase 0 studies are also known as human micro dosing studies. While Phase 0 studies are first-in-human studies, they are not designed to gain information on efficacy or safety.

The results of studies done under an IND are ultimately a part of the NDA for obtaining approval. There are exceptions to the requirement that agents not be used for treatment unless they have been proved to be safe and effective. Chief among these exceptions is the regulation allowing a so called “treatment IND” which allows an experimental drug which shows promise in clinical testing, to be used to treat serious or immediately life-threatening conditions before the final clinical 46 10 The FDA Approval Process and Drug Development work on the drug is conducted and the FDA review takes place.

FDA must have already authorized the claim; 2. S. government or a National Academy of Science scientific body must have issued a statement on the relationship; or 3. ” The third type of allowable claim, nutrient content claims, are very limited and may only be made based on FDA authorizing regulations. Nutrient content claims allow the label to state the level of a nutrient or dietary substance and use terms such as “free”, “high”, “low”, “more”, “reduced” and “lite”. As regards the safety of supplements, the company which manufactures or distributes the supplements is responsible for the agent’s safety and must have evidence to support that their claims are not misleading or false.

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