The conclusion drawn from our results is that the sensitivity to fosfomycin constitutes a test for differentiating Bacteroides from Sphaerophorus and that fosfomycin is ineffective in injections caused by Bacteroides, although it is an active antibiotic against infections caused by Sphaerophorus.1. The majority of these concentrations subsequently lie within therapeutic margins. On the other hand, all strains of Sphaerophorus were sensitive to lesser concentrations than the aforementioned. fragilis was tested, none of them were sensitive to concentrations of 200 mug/ml fosfomycin. The results obtained show that no matter what kind of B.

The sensitivities were determined by the progressive dilution method in a solid medium with a surface inoculation of the strain. in accordance with the scheme which we usually employ and which has previously been published. Identification was made morphologically and biochemically. Of the 178 strains that were tested, 156 were isolated from pathological products in our department and the remainder came from the following collections: NCTC, ATCC and the Institut fur Mikrobiologie of the University of Bonn. The sensitivity of 116 strains of Bacteroides fragilis and 60 strains of Sphaerophorus to fosfomycin was studied. Regulatory affairs professionals have a major role in identifying and resolving such issues at multidisciplinary interfaces, while also assuring that the method of resolution meets legal and regulatory requirements. Examples of pair-wise interfaces between disciplines are presented to illustrate the issues that must be identified, made subject to contingency plans, and resolved on an ongoing basis to assure efficient and successful drug development. In this paper, the basic mathematics of combinations is used to calculate the number of pair-wise interfaces among technical disciplines, as well as the number of interfaces among subsets of three disciplines. An increasing challenge for regulatory affairs professionals is to assure that an integrated, coherent, and nonconflicting set of information is developed across different disciplines The magnitude of this challenge is increased by the desire for more rapid drug development and the consequent increase in assumptions that are operative at any given time.

In the United States, a New Drug Application (NDA) must present apr integrated, coherent, and nonconflicting set of information both within each individual technical discipline and across all technical disciplines. Clinical sciences, 4 Human pharmacokinetics. Chemistry, manufacturing, and controls, 3.

Nonclinical pharmacology and toxicology, 2. The six broadly-defined technical disciplines that comprise drug regulatory applications are: 1. Successful, rapid, and efficient drug development depends on planning, coordinating, executing, and completing development activities in multiple technical disciplines.

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