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Determining the right regulatory pathway for a drug product is a critical early decision that can shape the entire development strategy. While many products may appear to fit the generic model, nuances in formulation, dosage form, route of administration, or intended use can disqualify them from a traditional Abbreviated New Drug Application (ANDA). In such…
In the complex and costly world of new drug development, pharmacokinetic (PK) modeling has emerged as a promising method for driving more efficient and cost-effective clinical trials. This scientific approach leverages mathematical models to describe the relationship between drug dose, concentration in bodily fluids, and time. By simulating these processes, sponsors can optimize dosing regimens…
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).1 Instead, within 3-5 years, the expectation will be to leverage an integrated safety assessment approach, combining information from a comprehensive battery of New Approach Methodologies (NAM). These methodologies…
Alzheimer’s Disease (AD) is a progressive, irreversible brain disorder that affects memory, thinking, and language skills. Age is the best-known risk factor for AD, with symptoms usually appearing after 60 years of age. According to the Alzheimer’s Association and the Center for Diseases Control and Prevention, the number of people living with AD in the…
Epilepsy is the fourth most common neurological disorder in the world1, affecting over 68 million people globally, and approximately 2.2 million people in the US2. In pediatric populations, it is estimated that about 470,000 US children under the age of 14 have epilepsy1. However, developing anti-seizure medications for pediatric patients has long been a challenge due…
Clinical Development