Exploratory development definition

Many of the issues relating to the definition of nonchni-cal laboratory study were addressed in the discussion of GLP 58.1 (Scope). Field trials in animals includes all efficacy studies of new animal drugs. Such studies are outside the scope of the GLP regulations. This is consistent with the GLP exemption for human clinical trials. The exemption for basic exploratory studies carried out to determine whether a test article has any potential utility would extend to early screening studies of a test article, the results of which are used to determine whether a test article merits further development or not. 

The first step in the product development process is establishing specifications after exploratory research to bring a product to market. Specifications are the quality definition of an article (dosage forms or the related materials for production) upon which acceptance for eventual market distribution is based. The data for establishing pharmaceutical product specifications for both drug substances and dosage forms are defined by identity, purity, strength, and quality, derived from the preformulation study. 

The second task involves defining the boundaries within which the model was derived and can be expected, without further motivation, to be an adequate description of the data. Within these bounds the model can replace the raw data (after all, the model is supposed to capture all salient features of the data), which will be useful when presenting the knowledge summarized by the developed model to nonpharmacometricians. The definition of these bounds can be based on the inclu-sion/exclusion criteria of the study or the realized covariate distribution. In the latter case, some of the exploratory plots from the before-analysis phase are useful. 

The development of incendiary rockets proceeded slowly because the Army did not ask for them and the Navy was only mildly interested. Without a definite military requirement, the CWS was not justified in diverting men and funds fi-om crucial projects. The work done was exploratory in nature, and served to give engineers experience that would have been useful if theaters of operations had suddenly requested incendiary rockets to place beside HE rockets. 

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