On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
Engaged in pharmaceutical consulting, the scientists and regulatory professionals at PDG® are tasked with design of pharmacokinetic (PK) protocols for a wide variety of applications. We understand that proper design and placement of your PK studies is critical, no matter the application.
We have written a basic overview of PK and pharmacodynamics (PD) principles, as well as an introduction to a cross section of the utility of PK studies. While not meant as a comprehensive compendium, included are brief discussions of the following as they relate to PK: pilot studies, ANDAs/505(b)(2), biowaivers, biosimilars, bridging, safety, dose response / dose regimen, route of administration, food/fasting effects, pediatric and geriatric considerations.
Pharmacokinetics (PK) is the study of how the human body processes a drug. Within humans, there are several biologic factors that are affected by drugs, commonly referred to as ‘ADME’ (absorption, distribution, metabolism, excretion).
In addition to ADME, other patient specific factors impact the way drugs are processed such as genetic make-up, age, gender, or influences of the disease state. Safe and effective use of any drug is dependent upon delivery of an adequate amount (concentration) of the drug to the receptor sites in a timely manner (rate) to properly influence the bodily systems in need of the drug.
Hence, PK is the application of quantifying and modeling techniques to the timing drug ADME in humans. To read more about PK and its uses, click here.
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...