When should you incorporate CPMS?

Clinical pharmacology modeling and simulation data is a pivotal segment of drug development, and it is common practice to incorporate CPMS later in clinical development. However, integrating CPMS earlier can bring tremendous benefits.  What role do CPMS experts play on the drug development journey?  Clinical pharmacology covers all aspects of interaction between humans and drugs, […]

What is Pharmacodynamics?

By Rachel Rozakis, PharmD, Clinical Pharmacologist II and Ben Kennard, MS, CPMS Intern Pharmacodynamics (PD) is the study of how drugs affect the human body given their mechanism of action. In contrast, pharmacokinetics (PK) is the study of what the body does to the drug and describes information about ADME: absorption, distribution, metabolism, and excretion. PK […]

When to Use 505(b)(1) & 505(b)(2) Pathways for New Drugs and Common Misconceptions

A fundamental question for any drug development program is which regulatory pathway to pursue. The answer is important to determine early on, because it dictates the scope of clinical and nonclinical studies that need to be conducted and how the marketing application will be presented to regulators. It also heavily influences a host of other […]

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 and a relevant in vivo response. When performing IVIVC for formulation development, the in vitro property is primarily dissolution or drug release and the in vivo response is primarily a drug’s plasma concentration or the amount/rate of drug absorbed.1. In […]

Best Practices in Clinical Study Protocol Writing

Clinical trials are a vital aspect of drug development and approval. Whether it be a single-site, Phase 1 study in healthy subjects to understand the safety and pharmacokinetics of a new compound or a multi-center, pivotal Phase 3 study to demonstrate efficacy in patients, there is no escaping the fact that clinical trials are necessary […]

What is a Human Mass Balance Study?

The goal of a human mass balance clinical study is to understand how drugs are absorbed, metabolized, and excreted (AME) after dosing. This information is important because it helps determine what other clinical investigations might be necessary for regulatory approval of a new drug. The AME process (also known as ADME when ‘distribution’ is included) is determined […]

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 that impair liver function (hepatic impairment) can affect how some drugs interact with the body. In particular, the pharmacokinetics (PK) of the drug may be […]

How to Successfully Prepare for Your Pediatric Study Plan

Starting in the early 1900s laws were implemented surrounding the safety and efficacy of drugs and biologics. Historically, the inclusion of pediatric use in drug labeling has significantly lagged behind. Ethical, monetary, and feasibility challenges all contributed to the lack of pediatric information in drug labels. The lack of pediatric data leaves physicians with only […]

Intrinsic and Extrinsic Factors in Drug Development

Personalized medicine (also known as precision medicine) is one of today’s biggest drug development buzzwords. It certainly stirs the imagination – the notion that one day we may live in a world where drug regimens are exquisitely tailored to an individual’s own biology. For some cancers, infectious diseases, and genetic diseases, we are already realizing this […]

Pharmacokinetic Considerations for Repeat-Dosing

Most prescription drugs are administered repeatedly for a limited duration (for acute illnesses) or for an extended period of time (for chronic conditions). As such, it is important to understand the pharmacokinetic (PK) behavior of drugs when they are administered according to repeat-dose regimens. Single-Dose PK Behavior For the purpose of this discussion, we will use […]