Recommendations development process

For PK assays, it is generally believed that most matrix effects are due to the sample matrix (typically plasma). While this is correct in many cases, this assumption has some exceptions (vide infra). One of the most useful tools for avoiding matrix effects is studying the sample matrix and proposed assay by using the post-column infusion technique described by Bonfiglio et al.14S This technique allows visualization of the portion of the chromatographic step affected by ion suppression.161721 Xu et al.101 recommended inclusion of this step in the method development process for drug discovery PK assays. 

The period in the drug development process at which results of these studies are required varies somewhat from country to country, but recommendations are made in the ICH guidelines. In most instances, Stage B studies are required prior to phase 2 clinical studies, the Stage A study is required prior to phase 3, and the Stage C study is needed for the NDA. Circumstances for an individual drug or requirements of certain countries may warrant a modification of this schedule. 

This approach is not recommended for process safety incident investigation. If the team conducting the incident investigation has been chosen for their experience, technical knowledge, and skills, they are best placed to develop the recommendations to prevent a recurrence. 

Contrary to what one would wish to see in an efficient clinical development process, the de-facto requirements for an IND continue to rise to the point where, in complexity and size, an IND today exceeds the size of some NDAs in the past. We recommend simplifying the IND requirements, so that key safety and early efficacy studies can be performed very early in humans with the same protections, but at less time and cost than they are today. 

Chao et al. [50] describe a systematic approach to process optimization through process understanding. They recommend developing a process summary that comprises four basic steps ... 

Some of the information in this paper was prepared for and taken from a US NIST project in process, an IT Security Standards and Guidelines Roadmap. For more details on becoming a standards draft reviewer and in fact on all levels of involvement in the development processes, please refer to the NIST document once it becomes available. It is also recommended that the NIST document be referenced for descriptions of types of SDO s, for SDO methods and processes, for SDO membership requirements, and for an overview of salient standards and guidelines important to IT Security. 

F/24 Use normal developing time recommended for processing without prehardener at 68F/20C... 

The system consists of two parts. The first part involves using either available information from the drug development process or making reasonable speculations to characterize the potential hazards to the workforce from exposure to the compounds. The second step involves using that information to assess the risk of exposure and recommend controls that prevent exposure. There is more than one suitable control method that can control most exposure points, and several examples have been provided. Finally, case studies have been provided to demonstrate the effectiveness of some of these control methods. 

The Chlorine Institute developed and released Pamphlet 86, Recommendations to Chlor-Alkali Manufacturing Facilities for the Prevention of Chlorine Releases, [16] in October 1990. This 15-page pamphlet acknowledges the ORC report Recommendations for Process Hazards Management of Substances with Catastrophic Potential was one of the primary documents used to develop it. 

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