Comparative biological response

See color plate) Effect of animal model and implant site on biologic response to polyurethane-coated stents. Comparable biologic responses to a bare-metal stent... 

Table III. Comparative Biological Response of 4 -(1,1,2,2-Tetratluoro-2-phenyletho) y)benzoylphenylureas...

Bioavailahility studies are used to compare different formulations of the drug product, or different batches of the same formulation and, as discussed in Chapter 8, generic copies of a reference drug. Their comparative value is based on the premise that, if similar amounts of identical active substance are delivered to the site of action at similar rates, then a similar biological response can be expected, which leads to the conclusion that the two preparations are bioequivalent. 

The uncertainty involved in the calculation of the energy dissipation rate makes it difficult to compare experimental results reported by different researchers. For the same reasons, so far it has proved difficult to assess flow induced effects in different items of process equipment using the common basis of equal energy dissipation rate. For example. Fig. 14 shows the biological response of (SF-9) insect cells as a function of the energy dissipation rates in a capillary tube and in a mechanically stirred vessel [99]. In these plots the calcula-... 

A recombinant IFN-P, IFN-pia (Rebif Serono and Avonex Biogen) is produced for commercial use in Chinese hamster ovary (CHO) cells. A synthetic mutant produced in bacteria has a substitution of serine for cysteine at amino acid 17, yielding IFN-pib Betaseron Berlex). Both IFN-pia and IFN-pib are approved by the FDA for treatment of multiple sclerosis (MS) and have shown comparable biological activity (see Section 7.3). In vivo IFN-a2 and IFN-alb show comparable biological activity as well as similar side effects [54,55]. However, IFN-P is eliminated faster, resulting in no detectable serum peak levels [56]. The clinical consequence of this is not known. Objective responses, whether partial or complete tumor regression, have been documented in patients with carcinoma of the breast, hairy-cell leukemia, and non-small-cell lung cancer [57,58]. 

Like IFN-a, IFN-co genes have duplicated to high copy numbers in ruminants but not in humans [64], Unlike IFN-a, IFN-co protein is 172 amino-acid residues long and is capable of eliciting similar biological responses in vitro as compared to other type I IFNs [36],... 

Rapidity. Sampling and analysis times should be short compared with biological response times, response time in 90% of samples should be less than 30 s, and output should be RS232 or the equivalent. 

Perry G., Taddeo M. A., Nunomura A., Zhu X. W., Zenteno-Savin T., Drew K. L., Shimohama S., Avila J., Castellani R. J., and Smith M. A. (2002). Comparative biology and pathology of oxidative stress in Alzheimer and other neurodegenerative diseases beyond damage and response. Comp. Biochem. Physiol. C-Toxicol. Pharmacol. 133 507-513. 

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