AUTHOR INDE

It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

See, for example, Wolfgang Ostwald, Kolloid Z., 1, 331 (1907) Z. Chem. Ind. Kolloide, 3, 28 (1908) An Introduction to Theoretical and Applied Colloid Chemistry, 2d Amer. ed., trans. by M. H. Fischer (John Wiley and Sons, New York, 1922). See also various texts by other authors, for example, A. W. Thomas, Colloid Chemistry (McGraw-Hill, New York, 1934), pp. 1-8. 

While not officially required, the FDA does have the authority to request, on a case-by-case basis, specific tests it feels may be necessary to address a point of concern. A genetic toxicity test could be part of such a request. In general, therefore, companies deal with genetic toxicity (after screening ) on a case-by-case basis, dictated by good science. If more than a single administration is intended, common practice is to perform the tests prior to submitting an IND. 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

A hrm or institution, called a Sponsor, is responsible for submitting the IND apphcation. The relevant authorities are the Center for Drug Evaluation and... 

Phase I, II, and III Trials An IND is submitted for each phase of clinical trial. Phases I to III. At any stage of the trial, the FDA has the authority to put clinical hold on the trial until deficiencies or safety issues are resolved. The Sponsor can request meetings with the FDA at various stages ... 

Most of the information sought is similar to the FDA s IND requirements. One major difference is that a Qualihed Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance. 

At pHsI, the Tafel slopes (Table I) for bare Cu emd Cu coated with PVI-1 or BTA are the same within experimental error. PVI-1 and BTA do not appear to affect the mechanism of 0 reduction on Cu. These results are supported by Heakal and Haruyama [12] who also found the Tafel slope of Cu with BTA present in a pH=3 solution of HNO ind 3% NaCl to be -0.18V/dec. These authors, however, do not cite a value for bare Cu. DDI-coated Cu shows a significantly different Tafel slope, -320mV/dec, indicating that a different mechetnlsm applies. 

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