Study completion date, proposed

A description and analysis of each controlled clinical study pertinent to the biologic s proposed use, including the protocol and a description of the statistical analyses used to evaluate the study. If the study report is an interim analysis, this must be noted and a projected completion date provided. Controlled clinical studies that have not been analyzed in detail for any reason (e.g., because they have been discontinued or are incomplete) should be provided, including a copy of the protocol and a brief description of the results and status of the study. 

Failure to complete registration stability studies Failure to include each marketed product in the stability program Stability data not evaluated as part of the annual product review Stability results do not support expiration dating period Batches evaluated under QA requested studies released before sufficient data were available Stability data do not support proposed changes... 

The RFP consists of a cover letter, detailed instructions to proposers, a copy of the study protocol, the completed study specifications worksheet, a resource allocations worksheet and a copy of the sponsor s standard CRO agreement. The cover letter should briefly describe the study goal, provide an overview of the clinical plan, specify the proposal due date, indicate that the CRO may be invited to present its proposal orally to the sponsor and specify the timing for the sponsor s reply. The CRO should be given approximately two weeks to prepare a proposal, and the sponsor should expect to reply to the proposals within two weeks. 

Pervaporation membrane reactors are not a recent discovery. The use of a PVMR was proposed in a U.S. patent dating back to 1960 [3.6]. Though the technical details on membrane preparation and experimental apparatus were rather sketchy, the basic idea was described there, namely, the use of a water permeable polymeric membrane to drive an esterification reaction to completion. A more detailed description of a PVMR can be found in a later European patent [3.7], which described the use of a flat membrane (commercial PVA or Nafion ) placed in the middle of a reactor consisting of two half-cells. The reaction studied was the acetic acid esterification reaction with ethanol. For an ethanol to acetic acid ratio of 2, liquid hourly space velocities (LHSV) in the range of 2-5, and a temperature of 90 °C complete conversion of the acetic acid was reported. The use of PVMR for this reaction shows promise for process simplification, as indicated schematically in Figure 3.2, which shows a side-by-side comparison of a conventional and a proposed PVMR plant for ethyl acetate production. 

For completeness, note that several researchers have exploited the well-developed analytical theories of the stmcture of fluids to model percolation in mixtures of interacting particles. By proposing various extensions of the multicomponent Omstein-Zernike equation, coupled with connectivity definitions from continuum percolation theories, simplified analytical expressions are derived for the percolation threshold of a composite system subjected to interparticle and medium-induced interactions. However, to date, simulations dominate the study of dynamic percolation. 

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