Form 33 - Safety assessment

There are multiple phases involved in the safety assessment portion of the discovery, development and marketing process. The actual conduct of the studies in each phase forms the basis of the bulk of the chapters in this book. However, unless... 

Focus of the development process for a new pharmaceutical is an essential aspect of success, but is also difficult to maintain. Clinical research units generally desire to pursue as many or as broad claims as possible for a new agent, and frequently also apply pressure for the development of multiple forms for administration by different routes. These forces must be resisted because they vastly increase the work involved in safety assessment, and they may also produce results (in one route) that cloud evaluation [and impede Institutional Review Board (IRB) and regulatory approval] of the route of main interest. 

Chemical interactions are almost always detrimental to the product because they usually indicate an incompatibility that gives rise to chemical compounds that would be classified as degradation products under ICHa Q3B, thus leading to requirements for quantitation, identification, and ultimately qualification (some form of safety assessment) depending on the level found. 

Start the process by filling out a Safety Assessment Form such as Form 11—1 on p.263... 

All fraud is also misconduct by definition, but misconduct per se is not so clear-cut. It could be accidental, for example missing the due date for patient assessments, or carelessly completing case record forms, but the point where carelessness becomes misconduct and misconduct becomes fraud is indistinct. A safety assessment might be omitted because the research team forgot... 

Finally, the scheme has generally not been considered, even by its proponents, appropriate to apply to carcinogens. This view may stem from the legal stricture (which exists in the United States in the form of the Delaney clause of the Food, Drug and Cosmetic Act) that no ADI can be established for a carcinogenic additive, in which case no safety assessment scheme is needed. On the other hand, it may stem from a scientific view that the mode of action of carcinogens is such... 

The relatively turbulent discussions of food safety in the last generation led some of the leaders in the food industry to form the Food Safety Council, with a Board of Trustees drawn from both public and private sources, to generate and propose a system of safety assessment that might serve as a nucleus around which to crystallize a system of general applicability. It formed a Scientific Committee to generate the scientific component of this system, and the work of this committee is the basis of this chapter. 

The prediction phase of safety assessment is also coupled to activities concerned with waste treatment, selection of the final form of the waste, and selection of repository sites and designs. Results of the predictions can impact these activities. LITERATURE CITED... 

Substances not included in the final inventory are defined as new and must be notified to the Federal Ministry of the Environment, Youth and the Family befcse they are manufactured or imported, unless notified mere than 10 years neviously. The authorities will publish an annual list of those substances which were notified 10 years earlier. New substances supplied exclusively for testing purposes are exempt from notification. Also exempt are those exported to specified countries where there are equivalent regulations for the notification or safety assessment of new substances, although the Austrian authorities must be notified in writing of the substance s identity and the expected production and expmt quantities, as well as the classification, labelling and proposed uses of hazardous substances. Finally, polymers are not notifiable, unless they contain >2% (by weight) in chemically-bound form of a new substance monomer. 

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