ISSUE NO. 34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics
Understanding a new drug’s absorption, distribution, metabolism, and excretion (ADME) is critical to ensure its safety for human use. That understanding is achieved through the collection and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data, which together account for approximately 25% of the contents of a drug package insert or label.
The characterization of PK/PD effects starts with nonclinical toxicokinetic (TK) studies in animals. The purpose of TK studies is to define the chemical properties of the drug, including pharmacology and toxicology, and to assist in the development of downstream clinical protocols. The necessary nonclinical studies are conducted before submission of Investigational New Drug (IND) applications to the FDA or other global regulatory agencies, and deliver critical data used to set the parameters for future clinical trials.
In Issue 34 of The Altascientist, we discuss how the understanding of a novel drug’s PK and PD properties begins with nonclinical studies and evolves through early-phase clinical trials, including:
- IND requirements and translation to clinical PK/PD;
- Translating nonclinical knowledge of PK/PD analyses to clinical study;
- How PK/PD scientists add value to drug development processes; and
- A scenario case study from Altasciences.
HOW DO PHARMACOKINETIC/PHARMACODYNAMIC SCIENTISTS ADD VALUE TO THE DRUG DEVELOPMENT PROCESS?
A PK/PD scientist will perform a myriad of tasks for your studies, some of these tasks may include:
- developing and validating analytical methods to measure drug concentrations in biological fluids, such as blood or urine;
- designing and conducting studies to assess the pharmacokinetic properties of drugs in humans or animals;
- analyzing and interpreting data from pharmacokinetic studies; and
- communicating the results of your PK/PD studies to stakeholders, such as regulatory agencies or drug development teams.
HOW ALTASCIENCES CAN HELP WITH YOUR TK/PK/PD STUDIES
With integrated nonclinical-to-clinical capabilities and our own bioanalytical laboratories, Altasciences can significantly accelerate your program’s advancement to first-in-human trials. Fewer handoffs, fewer supplier negotiations, and fewer confidentiality agreements to finalize means that data can flow quickly and efficiently to enable agile and flexible drug development.
All of Altasciences’ TK/PK/PD services are conducted in accordance with FDA, Health Canada, EMA, and ICH guidelines, and we routinely customize the outputs based on client requests, including the possibility of obtaining interim results. Approximately two-thirds of the nonclinical studies conducted at Altasciences are GLP, in support of IND applications. Our PK/PD team is trained to be both GCP- and GLP-compliant.
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