Follow-on studies

Follow-on studies are also recommended as needed. These include determination of potential test article effects on blood or tissue immunophenotypes (by flow cytometry or immunohistochemistry), natural killer cell, macrophage, or neutrophil function, host resistance to infection or tumors, and cell-mediated immunity. The important issue in all of these guidelines is this do not ignore signs of immunotoxicity, and assess these findings when observed. 

In a follow-on study, Silberston categorized three groups of industries for when patents are essential, very important or less important on the basis of both survey responses and objective analyses (patent and R D intensity). He concluded that, "The first category consists of one industry only, pharmaceuticals." Edwin Mansfield surveyed the R D director of 100 U.S. corporations on what fraction of the inventions they introduce, between 1981 and 1983 would not have been developed without patent protection. For pharmaceuticals, the value was 60%, while the average across all industries was 14%. ... 

Myriad Genetics reports that Flurizan is a selective amyloid-lowering agent (SALA) that reduces levels of the peptide amyloid beta 43 in cultured human cells and in animal models. Results of a completed Phase II follow-on study of Flurizan in patients with mild AD were presented in July 2006 at the International Conference on Alzheimer s Disease and Related Disorders. According to Myriad Genetics, results from this study reportedly... 

In anthropogenically impacted systems, Cotter-Howells Thornton (1991) used SEM-EDS to characterize soil grains from a Derbyshire, UK, mining village where Pb mining historically occurred. Many of the soil grains were chloro-pyromorphite. EXAFS was used to identify pyro-morphite in mine-waste-contaminated soils in follow-on studies (Cotter-Howells et al. 1994). 

Gabapentin is effective as an adjunct against partial seizures and generalized tonic-clonic seizures at dosages that range up to 2400 mg/d in controlled clinical trials. Open follow-on studies permitted... 

Trace mineralization including sporadic arsenic enrichment is present within the Illinois Basin, particularly in the southern portion and along its western edge (Erickson et al., 1987). Follow on studies failed to detect elevated trace-element contents in rocks of the central Illinois Basin (Goldhaber, unpubhshed data). However, data from further north suggests enrichment in elements related to MVT deposits including arsenic extending into southeast Minnesota, based on chemical analysis of acid insoluble residues from that area (Lively et al., 1997). 

To extend this Scunple eind to replicate our analysis, the National Science Foundation commissioned two follow-on studies, one by Robert R. Nathan Associates and one by Foster Associates. Nathan, based on its sample of 20 innovations, found the median social rate of return to be 70 percent emd the mediein private rate of return to be 36 percent. Foster, based on its sample of 20 innovations, found the median social rate of return to be 99 percent and the private rate of return to be 24 percent. Thus, their results, like ours, indicate that the median social rate of return tends to be very high, and much higher them the private rate of return. (The private rate of return is, of course, the rate of return to the firm that introduced the innovation.)... 

The PHL report is generally a narrative with a summary that highlights significant risks and recommendations. It should also contain a brief project description, a discussion of the PHL methodology used including the risk assessment matrix, requirements for additional information, recommendations for follow-on studies or analyses, and the PHL worksheets. 

Saiman L, Mayer-Hamblett N, Anstead M, Lands LC, Kloster M, Goss CH, et al. Open-label, follow-on study of azithromycin in pediatric patients with CF uninfected with Pseudomonas aeruginosa. Pediatr Pulmonol 2012 47(7) 641-8. 

In 1998 Harrison reported the synthesis and characterization of water-soluble, dynamic, cobalt-coordinated carcerand 16 (Fig. 9.7) [64]. A follow-on study 7 years later found that 16 can entrap a range of guests [65]. Competition studies revealed that anisole and p-xylene were the strongest binders both had an encapsulation preference 20,000 times stronger than the poorest guest, m-xylene. Harrison extended this work using the same cavitand complexed with Fe (II) [66]. The resulting carcerands were also water-soluble and were found to contain six waters. In the presence of bromobenzene-saturated water, the aromatic preferentially bound. 

The results of two follow-on studies performed on a broader scale are now on record, and these are summarized in Table 2 in terms of IC50 values. In addition to HeLa and LNCaP, the screens include the Colo 320 DM line. 

Pharmaceutical companies have attacked the problem from both ends. We mention briefly here that efforts to expand markets, reduce price controls, extend product lifecycles, and to shrink time to market, regulatory burden, and follow-on studies are key strategies for the pharmaceutical industry. The focus of this discussion however, is on the complementary issue of pharmaceutical R D itself. 

C. A. Anderson, Jr., 1000 MWe LMFBR Follow-On Study, Task I. USAEC Rep. WARD-2000-33, Westinghouse Electric Corp. (1969). 

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