Summary design guidelines

Summary of Design Guidelines for Multispecies Toxicity Tests... 

The analysis will also look for opportunities for hazard mitigation through identification of human error potential and improved information presentation by comparing the TA with HMI design guidelines from appropriate sectors. In summary, the CTA will enable the safety-related system developer to ... 

Design Guidelines and Techniques QuaUfication and Accelerated Testing Manulacturing Issues Summary... 

In designing wearable devices, there are several factors to consider. The main focus should be that it does not hinder the wearer s movements, unless intended for that purpose. Other important factors include the service life, reusability, the element of design, comfort level and functionality. Garment comfort and appearance is highly affected by the placement of the components. Table 9.2 shows a summary of design guidelines for wearable systems. 

A summary of evaluating hazardous materials can be found in the book Guidelines for Chemical Reactivity Evaluation and Application to Process Design (CCPS, 1995c) and Essential Practices for Managing Chemical Reactivity flaz-ards (CCPS, 2003d). For additional information, refer to IRInformation IM.1.8.0, Hazardous Materials Evaluation (Industrial Risk Insurers, 1998). 

The NCO should not be a mere repetition of the data presented in the narrative summaries a more analytical approach is needed to arrive at a robust risk-benefit balance. Any issues should be addressed and instances where the development program has deviated from the standard study designs or guidelines should be explained and justified. Negative findings should not be glossed over or omitted but should be dealt with openly and in an unbiased manner. Care should be taken to ensure that the NCO and written summaries are in agreement and do not contain any contradictions. 

EC) No. 440/2008, (43)). Deviations from the standard protocols should be reported in the robust study summary. Moreover, if a study does not comply with any specific guideline, all relevant information on the study design should be included in the summary so that the regulator can make conclusions on the reliability and significance of the study. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

Example templates for various tables recommended for inclusion in a marketing application are given in the ICH CTD guideline and these templates, or appropriate modifications of the templates, should be employed for summary presentations of results. A designation of ETA, for example template available, will be used throughout this chapter to alert sponsors that recommended table formats are available for their consideration. 

The criteria for process design for clean manufacturing focus on minimizing pollution, eneigy consumption, water consumption, secondary processes, or redundant processes. Table 5 provides a summary of suggested guidelines for materials selection and process design. 

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