Biological validation

Mai, A., Valente, S., Cheng, D., Perrone, A., Ragno, R., Simeoni, S. et al. (2007) Synthesis and biological validation of novel synthetic histone/protein methyltransferase inhibitors. ChemMedChem, 3, 987-991. 

The replacement of the anomeric oxygen by a CF2 has been considered to obtain hydrolytically stable difluoro-C-glycosides, difluoro-C-disaccharides and difluoro-C-glycopeptides. These compounds have been synthesized [65-68], but their use as inhibitors does not seem to have been biologically validated. 

The goal of the biological validation procedure depends on the nature of the process. If the process is intended to sterilize only, the probability of survival approach is used. In this case, validation studies must determine a dry-heat cycle that will assure that the probability of survival of the microbial indicator is not greater than 10 If the process is intended to sterilize and depyrogenate, which occurs when the materials can withstand excessive heat, the overkill approach is used. The goal here is to validate a heating cycle that can produce a 12-log reduction in the biological indicator population. 

Equations that apply for determining log reductions or survival probabilities are Eq. (11) and Eq. (12), respectively. Information that must be known prior to initiating biological validations include the D value of the biological indicator to be used, the change in its heat resistance as temperature is changed (Z value), and the presterilization microbial load on the commodity being steri-... 

Caputo, R. A., Rohn, K. J., Macoli, C. C. Biological validation of an ethylene oxide sterilization process. Dev Indus Microbio 22 357-362 (1981). 

Brohm, D., Metzger, S., Bhargava, A., Muller, O., Lieb, F., and Waldmann, H. (2002) Natural products are biologically validated starting points in structural space for compound library development solid phase synthesis of dysidiolide-derived phosphatase inhibitors. Angew. Chem. Int. Ed. 41, 307-311. 

Transcribed sequence with weak similarity to MOST-1 Protein What can you do with this information Is it possible to link a function to this hypothetical protein How much trust can you even have in this sequence Is it really a gene, or could it just be an error on the array Figure 8 and the following sections detail the steps that can be taken to assess the potential biological validity and functionality of this target gene. 

For the use in safety pharmacology, selection of a specific method for determination of the FSH receptor concentration is not important, however biological validation of the method is very important. In reference experiments, the effect of a preceding treatment on the concentration of FSH receptors should be detected, e.g. reduction in receptor concentration after inhibition of gonadotropin secretion. 

Type of genotoxic lesion Ecological realism Biological validity... 

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