Research and development procedures

To identify areas in which modifications in technical requirements or greater mutual acceptance of research and development procedures... 

To identify areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety and... 

The ICH was formed in 1989 (Secard International Conference on Harmonization, 1994 Worden, 1995). It provides a forum for discussions about the internationally varied technical requirements for product registration and identifies where modification and mutual acceptance of research and development procedures could lead to more economical use of resources. Ostensibly harmonizing only between the United States, the European Union and Japan, several other national regulatory authorities send representatives to these meetings, and the ICH lead is thus followed widely around the globe. 

Over the last 60 years criteria and methods based upon resuits of catastrophic events have been used for the design of expl facilities. The criteria and methods did not include a detailed or reliable quantitative basis for assessing the degree of protection afforded by the protective facility. Recentiy, extensive research and development programs have been undertaken to establish procedures which permit a more sound and scientifically based approach to current and future design requirements (Refs 1 to 9)... 

To carry on an active program in research and development in order to improve the procedures for the understanding and the diagnosis of the disease process in the newborn. 

Persistent research and development of the new decontamination substances, equipment and means is important to facilitate the decontamination procedures and to improve the efficiency of the decontamination. 

These specific, and other broader, concerns in corporate compliance with TSCA s requirements were discussed by Diamond Shamrock Corporation s D. Harlow. He described how corporate structures and procedures, including those for research and development, for companies of all sizes, have been impacted by TSCA. These impacts are generally positive in that they reflect greatly increased awareness, resources and responsiveness to questions of chemicals effects on health and environment. These benefits are seen to be in balance with their costs, expressed in the increased costs of products and services. 

The development of an adequate mathematical model representing a physical or chemical system is the object of a considerable effort in research and development activities. A technique has been formalized by Box and Hunter (B14) whereby the functional form of reaction-rate models may be exploited to lead the experimenter to an adequate representation of a given set of kinetic data. The procedure utilizes an analysis of the residuals of a diagnostic parameter to lead to an adequate model with a minimum number of parameters. The procedure is used in the building of a model representing the data rather than the postulation of a large number of possible models and the subsequent selection of one of these, as has been considered earlier. That is, the residual analysis of intrinsic parameters, such as Cx and C2, will not only indicate the inadequacy of a proposed model (if it exists) but also will indicate how the model might be modified to yield a more satisfactory theoretical model. 

The CVMP operates in a similar fashion to the CPMP and is heavily involved in the review of centralized procedures for veterinary products. It has developed a broad range of new guidelines to assist applicants in topics related to research and development for which no guidance existed previously. 

TTie system described here was developed for use in the research and development area hut has been readily transferred to a quahty-assurance environment. The ruggedness of the DC Plasma Spectrometer greatly extends the usefulness of the modules and drastically reduces sample preparation procedures, which are time-consuming and error-prone. 

Current Analytical Chemistry can be considered to consist of three closely related parts, viz. (a) research and development (b) the arsenal of techniques, methods and procedures formerly referred to jointly as "Chemical Analysis" and (c) education [1]. Consequently, analytes and samples are no longer the targets of Analytical Chemistry they have been superseded by the analytical problems derived from economic and social problems posed... 

US EPA (2003a). Procedures for deriving equilibrium partitioning sediment benchmarks (ESBs) for the protection of benthic organisms endrin. EPA-600-R-02-009. Office of Research and Development, Washington, DC 20460. 

This book deals with a subject that is both fascinating and vitally important for the pharmaceutical industry—the procedures of transferring the results of research and development (R D) obtained on laboratory scale to the pilot plant and finally to production scale. 

Laboratory equipment and procedures must be qualified and validated. Every NDA/ANDA inspection will include both an evaluation of laboratory controls and procedures and an audit of some of the raw data used to generate results. These data may be located in research and development test logs. The authenticity and accuracy of data used in the development of a test method should be established. (See the Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993.)... 

The dissolution is an extremely exothermic process that can be violent if the bath temperature is not carefully controlled at —78°. A preferred procedure developed by Dr. A. E. Feiring, Central Research and Development Department, Du Pont Experimental Station, involves keeping the pyridine as cold as possible without freezing (ca. —40°), then slowly condensing the HF into the vessel so that the entire mixture remains liquid during the preparation. Stirring is also helpful. 

Soy isolate was prepared by the isoelectric precipitation procedure developed at the Food Protein Research and Development Center, Texas A M University System (23). A commercial soy isolate. Promine F (Central Soya Inc., Fort Wayne, IN), was also used in this study. 

A panel of researchers at the FDA studied both effects and developed procedures to calculate the chronic risk. The confirmation of the risk, albeit very small, led to special attention rightfully paid to implantable devices based on TDI. Due in part to the long history of implanted polyurethanes based on MDI, such polyurethanes... 

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