Bracketing guidelines

Part II consists entirely of systematic names of specific compounds according to Chemical Abstracts nomenclature (see the Index Guide in Chemical Abstracts, Volume 76, 1972). Each compound is listed under the parent name as it would appear in Chemical Abstracts, and each entry from Volumes 56 through 59 is followed by the registry number in brackets. Entries from Volumes 58 and 59 are, for the most part, taken from the appendices which follow the procedures. When the Chemical Abstracts name differs in Collective Indices 8 and 9, both names have been included. Some compounds in the appendices of this volume have been omitted from the index in accord with the guidelines given for Part I. 

ICH Harmonized Tripartite Guideline—Bracketing and Matrixing Designs for Stability Testing of New Drug Substance and Products QID, 2002. 

The risk of lactate accumulation should be appreciated in patients with renal insufficiency, liver dysfunction and after acute illness with hypoxia, when therapy should be stopped. Although metformin is often bracketed with phenformin in the context of lactacidosis, different pharmacodynamics and adherence to prescribing guidelines render such a comparison unwarranted (Bailey and Nattrass, 1988). 

The reader will note many uses of qualitative terms to predict the behavior of these complex systems. As in the entire field of crystallization, these wide brackets around possibilities (e.g., will it crystallize, will it form an oil first, will it stay amorphous, will it grow, will it nucleate, what is good mixing, what is low supersaturation, etc. ) are necessary because of the extreme species and conditions dependency of the crystallization of organic molecules. The guidelines offered are intended as such and, in addition, to provide a framework for experimentation to determine where a particular system may fit in the wide scope of crystallization behavior possibilities. 

The use of experimental design to reduce the amount of testing has been accepted and is enshrined in the ICH guideline on bracketing and matrixing, so there is certainly some scope to further explore the options in this area. 

When one uses the ideas or words of another author, proper attribution is made in the report. A mark (superscript number, number in brackets, or author name and date in parentheses) is shown in the text at the point where the work is used. The complete citation is given either in a foomote at the bottom of the page or at the end of the body of the report in a separate section. The format for the text mark and for the citation are set in the guidelines of the organization and must be followed. 

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