The Food and Drug Administration (FDA), Center for Drug Evaluation Research (CDER) has a requirement to develop and evaluate an in vitro test protocol that is able to detect changes in manufacturing or formulation when Q1 and Q2 are the same or very similar. If possible a measure for Q3 can be proposed. The FDA has used concepts of Q1, meaning qualitative similarity between generic and reference listed products, and Q2 representing quantitative similarity of composition. These two concepts are not sufficient to say that two products are the same. Thus, Q3 is introduced as a newly defined term that describes similarity of manufacturing process variables resulting in structural similarity and refers to the physical attributes and state of aggregation of the product. The duration of the project will be one year. RFQ available on or about 7/26/03.

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