DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS

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The Division of Acquired Immune Deficiency Syndrome (AIDS) and the Microbiology and Infectious Disease Program of the National Institute of Allergy and Infectious Diseases are actively engaged in programs to: carry out basic investigations of the infectious disease process, and discover novel therapeutic approaches to treat these conditions via the National Cooperative Drug Discovery Group mechanism and screening programs. These therapies are directed at a wide variety of infectious diseases including those produced by HIV, cytomegalovirus, Herpes simplex, Pneumocystis pneumonia, Candida albicans, Mycobacterium avium complex, etc. Some but not all of the NIAID funded drug discovery mechanisms have the capability and capacity to carry out the required studies to convert chemicals exhibiting activity in a predictive in vitro test system or animal model into a pharmaceutical dosage form manufactured on sufficient scale to permit phase I and II clinical evaluation of the substance. This initiative provides the capability to develop the following dosage forms: sterile freeze dried, sterile liquid, capsule, and tablet formulations and a manufacturing scale adequate to prepare batch sizes of 4000 vials (2 lots annually); 50,000 tablets (two lots annually) and 50,000 capsules (one lot annually). The contractor will carry out the required quality control tests on all manufactured lots and also determine the stability of the formulations under simulated use conditions. These studies will be conducted in accord with the Food and Drug Administration's current Good Manufacturing Practice Regulations.