What is Steady-State Concentration in Pharmacokinetics?
Need a refresher on what steady-state concentration is, how long it takes to reach steady state, and why this value is key in drug development? Here, we answer the most…
Read MoreStudy Design and Conduct
Tissue-Agnostic Therapeutics and Biomarkers in Oncology
Currently, there is a need for novel cancer therapies. This is due not only to the prevalence and biological complexity of this class of diseases but also to the intractability…
Read More
What are Real-World Data and How Can they Benefit Drug Development?
Real-world data (RWD) are data that come from sources other than traditional clinical trials and are becoming increasingly important to today’s healthcare decisions. Historically, drug developers have been limited to…
Read More
What is Allometric Scaling and How Does it Support Drug Development?
There are many aspects of drug development that must be understood before a drug can be tested in humans. Nonclinical studies are conducted to understand the safety (i.e., toxicity and…
Read More
What is IVIVC?
An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form (primarily dissolution or drug release)…
Read More
What is a Human Mass Balance Study?
A human mass balance clinical study aims to understand how drugs are absorbed, metabolized, and excreted after dosing. This information is important because it helps determine other clinical investigations that…
Read More
Surrogate Endpoints – Neither the End nor the Point
In an article published in June 2018 in JAMA Oncology, the FDA reviewed their accelerated approvals for malignant hematology and oncology drugs over the previous 25 years. In an earlier…
Read More