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 MorePharmacokinetics & Pharmacodynamics
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
9 Tips for Preparing a Successful New Drug Application (NDA)
It’s never too early to start planning for your NDA Begin assembling your NDA early Understand the relevant statutes and regulatory guidelines that apply to your program Use standardized templates…
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
Pharmacokinetics in Patients with Hepatic Impairment
The liver is responsible for the metabolism and clearance of many different drugs and their metabolites. Because of the liver’s importance in removing drugs from the body, diseases or injuries…
Read More
Cellular and Gene Therapies: What Is My Optimal Dose?
One of the basic tenets of pharmaceutical drug development is the selection of an optimal dose to give to patients. Dose selection is important because too small of a dose…
Read More