Abstract

Overview of Biotechnological Products: Their Pharmacokinetics and Pharmacodynamics Consideration

Author(s): Janhavi Mishra

Biotechnology derived drugs (biotech drugs) include large molecules like soluble proteins, monoclonal antibodies and antibody fragments as well as smaller peptides, antisense oligonucleotides and DNA preparations for gene therapy. Over the past two decades, a growing portion of pharmaceutical R&D has been devoted to biotech drugs. For biotech drugs, choosing the best route of administration necessitates a thorough understanding of their absorption characteristics that go beyond physicochemical properties. These characteristics include expression levels, passage through biomembranes, chemical and metabolic stability at the absorption site and active uptake and exsorption processes. Therefore, it is expected that pharmacokinetic and pharmacodynamic approaches will continue to play a vital role in the successful advancement of therapeutic products derived from biotechnology in the future. The same pharmacokinetic and pharmacodynamic principles that apply to conventional small molecule pharmaceuticals medications also apply to biotechnological pharmaceuticals like peptides, proteins and oligonucleotides. Furthermore, there are recommendations for PK/PD related drug development, such as those in the recently released exposure response guidance document of the US food and drug administration and the ICH E4 guideline of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use.