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 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 […]

How to Use Modeling and Simulation to Optimize a 505(b)(2) Application

A 505(b)(2) application is a hybrid of a full new drug application and an abbreviated new drug application. The terms 505(b)(2), 505(b)(1), and 505(j) all refer to sections of the federal 505 code that governs the applications for new and generic drugs. Modeling and simulation is a broad field that uses mathematical models to describe […]

FDA Project Optimus: Selecting the Optimal Dose for Oncology Therapeutics

Across the spectrum of therapeutic indications, typically, the majority of new investigational drugs are evaluated in randomized dose-ranging clinical trials. These types of clinical trials enable a reasonable understanding of dose-response and exposure-response relationships and provide a rational basis for selecting the optimal dose in subsequent pivotal clinical safety and efficacy trials. In oncology however, […]

How to Form a Clinical Pharmacology Strategy for your NDA, BLA, or MAA

It’s common knowledge that every approved drug on a pharmacy shelf must undergo extensive testing to demonstrate safety and efficacy. However, there is much more that goes into the approval of a drug. Every drug also goes through an extensive review of clinical pharmacology data. If you look closely at a drug’s package insert (that […]

Pharmacokinetic Parameters in Drug Development

A complex biochemical “dance” occurs between the body’s natural processes and the chemical composition of pharmaceutical drugs when taken by humans. These complicated interactions are measured and described using pharmacokinetic and pharmacodynamic parameters. Pharmacokinetics (PK) describes the absorption, distribution, metabolism, and excretion (also known as ADME) of drugs in the body. Pharmacodynamics (PD) describes how biological processes in […]