Pharmacology

The Biopharmaceutical Development Program (BDP) provides resources for the development of investigational biological agents. The BDP supports feasibility through development and Phase I/II cGMP manufacturing plus regulatory documentation. The BDP was established in 1993. We support the development of monoclonal antibodies, recombinant proteins, therapeutic peptides, and DNA vaccines, virus therapeutics and vaccines, gene therapy products, and other biological agents. Since its inception, BDP has completed more than 100 projects. The program has released over 220 lots of different products sinc… [learn more]

The Pharmacogenetics Core is responsible for correlating outcome observations (toxicity, efficacy, survival, PK/PD) with genetic variants (germline or somatic) to identify key genetic determinants and biomarkers that predict response to specific treatments. We also evaluate the impact of genetic variants on drug metabolism, transport, and molecular targets that influence drug resistance or contribute to inter-individual variation in therapeutic outcomes. [learn more]

The PPS encompasses all scientific analyses related to pharmacology, once the specimen has been collected and stored. There is a multi-step process to evaluate how the drug is being handled by the body after administration. The first step is to measure the drug concentrations longitudinally. This step is performed by the CPP’s Bioanalytical Unit: Bioanalytical Unit The Bioanalytical Section of the CPP is responsible for the measurement of drug concentrations in samples, either clinical or nonclinical. Our facility is staffed by a PhD Staff Scientist/Deputy Head of the CPP, a PhD la… [learn more]

The CPP is directly responsible for the pharmacokinetic (PK) analysis of numerous Phase I and II clinical trials conducted within the NCI. In addition, the CPP provides direct PK support for many studies performed elsewhere in the extramural community. The program provides bioanalytical support (LC-MS) and pharmacokinetic-pharmacodynamic (PK/PD) modeling and simulation of investigational agents or combination therapies to predict exposure-response in future trials (Pharmacometrics Core). The CPP can also assist with determining protein binding, drug-drug interactions, concentration-effect anal… [learn more]

The NIH Clinical Center Pharmacy Department provides pharmaceutical care to inpatients and outpatients on NIH intramural research protocols at the NIH Clinical Center. The Clinical Center facility encompasses 200 inpatient beds, 93 day-hospital stations, and 15 clinics. Clinical Center pharmacy staff provide sophisticated research support to health care providers as well as clinical investigators. Pharmacists conduct and participate in research programs that enhance knowledge regarding investigational drugs and new uses of commercially available agents. The Pharmacy Department's Investigation… [learn more]