Recommendations development attributes

These data show clearly that the structure-property relationships which apply to hydrophobic organic chemicals such as the chloro- and alkyl-aromatics also apply to the phenols, but the relationships are more scattered and less well defined. The absolute values of properties differ greatly. This scatter is probably attributable, in part, to insufficient experimental data or errors in experimental measurements, to dissociation and to the greater polar character of these chemicals. It is not recommended that correlations developed for non-polar organic chemicals be applied to the phenols. Separate treatment of each homologous series is required. 

This chapter develops characteristics of high quality recommendations necessary for achieving successful implementation. The first section is a presentation of the major concepts related to recommendations, such as attributes of good recommendations, management of change, and inherent safety. The second section expands on the attributes and presents a systematic discussion of the flowchart for recommendations. 

The attributes of successful recommendations are addressed in detail in Chapter 10. The incident investigation team has the responsibility to develop and submit the recommendations. It is management s responsibility to act on and resolve the recommendations. Management usually determines target dates and assignment of responsibility. 

Evaluate liver function tests at the start of and during the course of voriconazole therapy. Monitor patients who develop abnormal liver function tests during voriconazole therapy for the development of more severe hepatic injury. Discontinuation of voriconazole must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to voriconazole. Hepatic function impairment It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) receiving voriconazole. 

For the use of M oleifera leaves as nutritional snpplement, we propose the following initial standards for moringa, thns providing to users and international community recommendations for consistent and defined products (Table XV). The development of clear grades and standards for moringa should provide a foundation upon which researchers, processors, and prodncers can objectively define this product and then compare final qnahty and nntritional attributes. 

Herbal substitutes for dru [s of abuse A variety of herbal mixtures are offered for sale in magazines, on the internet and in so-called smart , eco or head shops. Many are marketed as herbal Ecstasy and the plants included in the formulations include Yohimbe bark, Kava-Kava (Piper methysticum),Y-3 e.emi, Hops, Jaborandi and Alisma. One product contains Kava-Kava, Guarana, Uva Ursi and Cascara bark. Many of the products sold as herbal Ecstasy contain either Ephedra sinica (Ma huang) or the Indian plant Sida cordifolia which both contain the alkaloid ephedrine (see R03c, Chapter VI). Other alkaloids may also occur, such as pseudoephedrine, norephedrine and norpseudoephedrine. The side-effects of ephedrine include tachycardia, anxiety, insomnia and arrythmias and a hypotensive crisis may develop if monamine oxidase inhibitors are also taken. Many adverse reactions and more than 20 deaths have been attributed to ephedrine and Ephedra consumption. Research conducted in the US shows that the daily intake of some Ephedra products would give ephedrine levels well above the recommended therapeutic doses. 

Once the discovery project team s recommendation for preclinical development of a lead candidate is accepted by management, this team is either disbanded or continues its efforts to discover other compounds with attributes that could identify a next-generation lead. Many of the discovery project team members become members of the more formal preclinical development project team. 

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