Production in the Sterile Products Section of PDS has been suspended. Please call 301-496-1031 for further information.
About the Pharmaceutical Development Section
The Pharmaceutical Development Section is the component of the NIH Clinical Center Pharmacy Department responsible for managing investigational drugs. This is done using computerized information systems; by manufacturing customized investigational drug formulations; and by helping investigators set up double-blind studies and file investigational new drug (IND) applications with the Food and Drug Administration (FDA).
Support for NIH Clinical Center research
- manages commercially available and investigational drugs in approximately 1,000 research protocols, including 200 masked studies;
- oversees the use of all investigational drugs—monitoring drug distribution, accountability, and quality; and
- conducts research on various practical applications of investigational drugs, including compatibility and stability.
The staff of 20 includes pharmacists, chemists, technicians, and fellowship-trained pharmacokineticists. They play integral roles in the myriad of clinical studies conducted at the NIH Clinical Center. They oversee the production of tablets and capsules and sterile parenteral dosage forms, as well as the formulation and production of dosage forms not available from commercial sponsors. The analytical unit conducts quality control studies to ensure the integrity and purity of the products produced.
Model of excellence
No other hospital pharmacy in the country has this range of manufacturing capability, which helps speed initiation of new clinical protocols by formulating and producing a final dosage form in a matter of weeks. Investigators were early contributors to the forerunner of drug compatibility and stability guides used in nearly every hospital pharmacy in the country.
The Clinical Pharmacokinetics Research Laboratory, the research arm of the section, is dedicated to the study of clinical pharmacokinetics and pharmacogenetics. Staff published a major definitive study that gained worldwide attention when they highlighted a serious drug interaction between St. John’s wort and indinavir, a protease-inhibitor drug used for the treatment of HIV/AIDS. Thanks to the study, much needed focus was placed on potential interactions between prescribed drugs or investigational therapies and natural products/ nutritional supplements. Kineticists continue focusing research efforts on potential drug interactions, as well as the characterization of new therapies, such as sodium nitrite in sickle cell anemia.
The design of a new space, replacement of aging equipment, and addition of a full-time dedicated quality assurance staffer will assure better alignment and continued compliance with FDA’s current good manufacturing practices.
Pharmacy Department Chief Robert DeChristoforo shows the new Zanasi capsule-filling machine that has a capability of filling 50,000 to 70,000 capsules per day. The number of capsules pictured is approximately 125,000.
Pharmaceutical Development Section technician Lana Frid models the proper garb when preparing sterile products in the new clean room of the Product Development Unit.
Clinical Center Director Dr. John I. Gallin and Pharmacy Department Chief Robert DeChristoforo led members of the media on a tour of the new production facility prior to the transition from existing space in the old building 10.
Pharmaceutical Development Section Chief George Grimes, Jr., does the honors at a ribbon-cutting on January 8, 2010 noting the new space for the section. He gets some support from CC Director Dr. John I. Gallin (left) and Pharmacy Chief Robert DeChristoforo.
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