REMARK guidelines

As concluding remarks for this Guidelines book on chemical reactivity concerns, a few notes on future trends and issues regarding chemical process saftey are presented as follows ... 

The study objectives, hypothesis/aim of the study, and the genes or polymorphisms to be assessed shonld be stated in advance of the stndy (see Note 1). It should be made clear whether the study is retrospective or prospective. If REMARK (35) guidelines have been followed, this shonld be stated and referenced. 

In the REMARK system, estimated effects (e.g., hazard ratios) with confidence intervals for the marker were recommended for univariant and key multivariable analyses, and a Kaplan-Meier plot was recommended to represent the effect of a tumor marker in a time-to-event outcome. The discussion section should interpret the results in the context of the pre-specified hypothesis and describe limitations of the study as well as implications for future research and clinical value. These guidelines were advocated for reporting of tumor marker studies in breast cancer research and treatment (63). 

Hayes DF, Ethier S, Lippman ME. New guidelines for reporting of tumor marker studies in breast cancer research and treatment REMARK. Breast Cancer Res Treat 2006 100 237-238. 

There is a remarkable degree of harmonisation between the USP approach and the ICH 3 Note for Guidance on validation of analytical methods for the pharmaceutical industry and the NMLK No. 4 guidelines for the food industry. 5 The requirements for the latter two are given in Table 12. For more detailed discussion of the pharmaceutical requirements see ref. 28. 

Remark 1 The above guidelines assume that we have one hot and one cold utility each located at the top and bottom respectively of the temperature range. In the case, however, where there exist multiple hot and cold utilities then we first identify the hottest hot utility and the coldest cold utility and define the rest of the utilities as intermediate hot and intermediate cold utilities. Subsequently, we treat the intermediate hot and cold utilities as hot and cold process streams for purposes of the partitioning into temperature intervals. In other words, we have to apply the two aforementioned guidelines for both the hot and cold process streams and intermediate hot and cold utilities. Another pictorial representation of the four temperature intervals is shown in Figure 8.3 along with the hot and cold stream data. 

Remark 3.4. In the context of the present chapter (and of the remainder of the book), the term hierarchical control structure reflects the use of two (or multiple) coordinated tiers of control action, and should not be confused with hierarchical plant-wide controller design strategies (see, e.g. Ponton and Laing 1993, Luyben et al. 1997, Zheng et al. 1999, Antelo et al. 2007, Scattolini 2009, and references therein), which use the term hierarchy to denote a set of guidelines, to be followed in sequence, for designing the control system for a chemical plant. 

This simple and useful guideline implies however several remarks ... 

In fact, these recommendations are drawn from the Draft Guidelines for-Investigators System Validation (USFDA, 1998) and private and public remarks of FDA spokesperson Mr. David J. Bergeson, 1998-1999. 

One critical remark on this topic is this According to EDA guidelines, an electronic signature shall be equivalent to a handwritten signature. The approver certifies with the signature that he read, understood, and accepted the entire content of a document. With electronic systems it is common practice to apply signatures... 

Remarks a) Guideline For non-regulated a) Potential for adverse RW (Richtwert) ... 

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