title: Overview of therapeutic drug monitoring and biotechnologic drugs.
abstract: Therapeutic drug monitoring (TDM) is the science that combines measurement of serum drug concentrations with clinical pharmacokinetics. Biotechnological drugs may be obtained by recombinant DNA technology, monoclonal antibody technology, polymerase chain reaction, gene therapy, nucleotide blockade, peptide technology, and carbohydrate technology. Examples of biotechnological drugs include antisense drugs, clotting factors, hematopoietic factors, hormones, interferons, interleukins, monoclonal antibodies, tissue growth factors, and vaccines. For drugs that are physiological peptides used for substitution therapy, TDM is not indicated. For other biotechnological drugs, the criteria developed for monitoring of "classical" therapeutic agents should be used on an individual basis to determine whether there is a role for TDM.
authors.affiliation: Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Philadelphia 19104, USA.
authors.forename: B A
authors.initials: BA
authors.lastname: Wolf
mesh_terms: D001709:Biotechnology / Q000379:methods; D004274:DNA, Recombinant; D016903:Drug Monitoring; D006801:Humans; D010599:Pharmacokinetics
chemical_list: D004274:DNA, Recombinant