CDER Conversations
Interviews with CDER experts on priorities, projects, and initiatives
Setting and Implementing Standards for Narrow Therapeutic Index Drugs
CDER reviews drug applications to ensure the products are safe and effective. When we review applications, we always evaluate the appropriate drug dose that should be delivered to a patient for their condition. All drugs have a therapeutic window, which is the dose range that provides effective therapy and avoids serious adverse effects (or side effects). Doses above the therapeutic window can produce serious side effects and doses below the therapeutic window are likely to be ineffective. Most drugs have a wide therapeutic window but a small set of drugs, narrow therapeutic index (NTI) drugs, have a much tighter therapeutic window and require more careful consideration to determine their optimal dose.
In this CDER Conversation, Liang Zhao, PhD, director of the Division of Quantitative Methods and Modeling in the Office of Generic Drugs (OGD), and Mehul Mehta, PhD, FAAPS, director of the Division of Neuropsychiatric Pharmacology in the Office of Translational Sciences (OTS), discuss how CDER helps ensure the dosage range of these NTI drugs falls within a safe and effective therapeutic window for patients. The experts also discuss the specific challenges and opportunities in developing NTI generic drugs.
More with Liang Zhao, PhD and Mehul Mehta, PhD, FAAPS