Testing fast-track

As noted in Chapter 1, the priorities in batch processes are often quite different from those in large-scale continuous processes. Particularly when manufacturing specialty chemicals, the shortest time possible to get a new product to market is often the biggest priority (accepting that the product must meet the specifications and regulations demanded and the process must meet the required safety and environmental standards). This is particularly true if the product is protected by patent. The period over which the product is protected by patent must be exploited to its full. This means that product development, testing, pilot plant work, process design and construction should be fast tracked and carried out as much as possible in parallel. 

Clinical Trial Application (CTA) has to be submitted to Health Canada seeking permission to conduct clinical trials. The submission should include information regarding drug characteristics, test data, animal studies, and clinical protocol. A clinical trial may be stopped when either it is shown to be unsafe or dramatic benefits are obtained. The approval process may be fast-tracked if a drug is shown to have substantial benefits, such as for treatment of life-threatening or severely debilitating conditions. 

BOX 4.7. NONTRADITIONAL CLINICAL TESTING PATHWAYS—FAST-TRACK CLINICAL TESTING AND FDA REVIEW... 

A tiered testing process will be phased in over a twenty year period, and is expected to cost industry approximately 2.5 billion, with an administrative staff of almost 200, to be paid for by a service fee levied on industry. Of major concern with HPPs is a fast track authorization provision for PBTs. As already noted in Sec. 24.3.4 above, HPP producers and importers must ensure accuracy of the definition of PBTs as (P-i-B-i-T)s or face the specter of across-the-board regulatory restrictions on their products due to exercise of the Precautionary Principle. 

The purpose of an inspection and test plan (ITP) is to summarise and present in a user friendly tabular form the complete programme of inspections and tests for the whole contract scope or for a section thereof, based on information extracted from the relevant drawings, specifications, codes, standards and regulations. It is intended for day-to-day ready reference on site. The ITP can be produced contractually by the construction contractor, which has the advantage that it will in effect own the document and benefit from having produced it. Alternatively, it could be produced by the EPCM contractor. This latter option would be appropriate in a fast-track project where there would be little time to prepare the document before putting it into application. 

Additional practical changes that would shift the balance back towards local production include effective implementation by TFDA of their formal commitment to fast tracking of tests and registrations for local products (which may require additional TFDA resources). Providing trade credit for local suppliers to public procurement, as well as to overseas importers, would also rebalance the incentive structure, as would more timely funding by the Ministry of Finance for procurement by MSD of locally contracted supplies. 

The current route for drug development is outlined in Figure 1 and can be found on the web at http //www.FDA.gov/cder/handbook. In 1988-89 regulations were loosened with respect to drugs proposed for the treatment of AIDS-related illnesses so that new drugs could be prescribed before all of the extensive testing was finished. This is referred to as the "fast" or "parallel track". 

The main difficulty encountered in testing the various models of Ps formation arises due to the fact that they involve fast processes (in the range of subpicoseconds) of radiation chemistry, in a medium (the terminal track of the positron) that is clearly not in thermal equilibrium. In addition, the only parameter generated in an experiment is the o-Ps intensity, which depends in a complex way on many competing processes, which are very difficult to control. 

The analysis of the data is till under investigation. So far the whole MX-42(X) dataset was analysed with respect to the number of satellites for each epoch. At the time of the experiment six satellites were visible. In about 90 % of the epochs the receiver was tracking 4 or more satellites and there were only very few with no or one satellite due to the obstructions mentioned above. This shows that the receiver was able to reaquire satellites very fast after obstraction even in this difficult environment. It can be concluded from this first test, that in case of a more suited environment like in an aircraft or a ship the receiver would perform very well. Table 1 summarizes the availabilty of satellites during the navigation test. 

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