Complex Concentration-QT Analysis

A Concentration-QT (C-QT) Analysis is a modeling and simulation technique used to help establish the risk of prolonging the QT interval. C-QT analysis can sometimes eliminate the need for a TQT study, which is more expensive and time-consuming. In a C-QT analysis, pharmacokinetic data (concentration of a drug over time) is time matched with EKG […]

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 […]

What is Clinical Pharmacology?

By Neha Bhise, PhD, Sr. Clinical Pharmacologist Clinical pharmacology is a translational scientific discipline which strives to understand the actions and behaviors of drugs in humans by combining it with the knowledge of human pharmacology. The study of clinical pharmacology is fundamental to our understanding of how drugs are processed by our bodies and how […]

Leveraging Modeling & Simulation for Pediatric Drug Development

Developing drugs for pediatrics has been historically challenging due to the vulnerable nature of this special population. When it comes to developing pediatric drugs, it is vitally important to understand the nuances inherent in the field. Gaining informed consent from families, encountering possible dissent from the children involved, and achieving acceptability from study personnel are […]

What is Pharmacokinetics and ADME?

By Rachel Rozakis, PharmD, Clinical Pharmacologist II  Pharmacokinetics (PK) is the study of how a drug moves throughout the body and provides important information on the systemic exposure to the drug over time. Conversely, pharmacodynamics (PD) describes what a drug does to the body, meaning, the pharmacologic response that occurs when a drug has reached […]

Understanding How PK Data and CDISC Work Together

The “Clinical Data Interchange Standards Consortium” (CDISC) is a not-for-profit organization that develops data standards for drug development. CDISC works with global regulatory agencies to develop guidelines and requirements that influence the standards for both clinical and nonclinical study data. Standard CDISC formatting guidelines help enable a more efficient submission and review process by providing […]

Common Clinical Pharmacology Mistakes to Avoid in Drug Development

Drug development is a complex process where clinical pharmacology data must be generated to support regulatory approval and marketing authorization. Each drug program has unique challenges and special circumstances, but programs often make the same types of mistakes. These mistakes can range from simple errors to large missteps that can threaten a drug’s chance for […]

Compartmental Modeling in Pharmacokinetics

Pharmacokinetic (PK) modeling is a tool used to help drug developers understand a drug’s effects on the body by analyzing its absorption, distribution, metabolism, and excretion (ADME) properties. These effects are typically summarized using PK parameters such as clearance and volume of distribution which are necessary for understanding the effects of a drug on the […]