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Value in global standardization of outbred rats for regulatory pharmaceuticals studies


, : Value in global standardization of outbred rats for regulatory pharmaceuticals studies. Experimental Animals 53(4): Suppl 57-63

As a result of a revolution in globalization over the last 10 years, few pharmaceutical companies conduct their non-clinical studies within a single region and virtually none conduct all non-clinical studies in house. The increased activity of product in-licensing at all stages of development results in further segmentation of toxicological source information. Juxtaposed to this segmental collection of toxicology information is the nature of toxicological testing for pharmaceuticals, an iterative process, carefully building subsequent testing designs and analyses upon the foundation of previously identified outcomes and associated safety issues. As a consequence of the segmentation of global product development, today's analyses of toxicological outcomes for single pharmaceutical projects often involve a conglomeration of results from studies conducted in several world regions using a variety of sources of animals. Such practices can lead to discordant study results and difficulty in understanding or rationalizing a compound's toxicological and pharmacological profile, and eventually how this relates to human risk. Despite the variety in source information, an integration of the total toxicology/pharmacology data must be made by industry, and/or by health authorities. To improve this integration, the development and use of better standardized genetics for rodent species used in pharmaceutical testing is more imperative today than in the past, as a result of a constellation of changes in industry policies.

US$29.90

PMID: 15356908


Other references

Baker C.H., 1969: Blood flow and volume distribution with elevated venous pressure. Physiologist 12(3): 163

Courtois B.; Gilbert J.C.; Koechlin R., 1970: Experiment using a sagem 8 200 teleprinter installed in nancy france for interrogation of the elliott 41 30 of the programming institute of paris with regard to a documentation file system. Genie Biologique et Medical 1(3): 87-89

Mateescu, R.G.; Burton-Wurster, N.I.; Tsai, K.; Phavaphutanon, J.; Zhang, Z.; Murphy, K.E.; Lust, G.; Todhunter, R.J., 2008: Identification of quantitative trait loci for osteoarthritis of hip joints in dogs. Objective - To identify quantitative trait loci (QTL) associated with osteoarthritis (OA) of hip joints of dogs by use of a whole-genome microsatellite scan. Animals - 116 founder, backcross, F<sub>1</sub>, and F<sub>2</sub>...

Daruwalla, E.; Lokhande, H.; Padhye, M., 1970: Spectral studies on deuterated celluloses in 3mu region. Cellulose chemistry and technology: 4 (1) 107-110

Leroy, J.L.; Mutter, D.; Forgione, A.; Inoue, H.; Vix, M.; Bailey, C.; Marescaux, J., 2006: The new 4DDome prosthesis: an original light and partially absorbable composite mesh for hernia repair. The use of non-absorbable meshes for the repair of inguinal hernias has become standard; however, these meshes have been associated with complications including long-term postoperative pain. To this end, a new partially absorbable composite mesh h...

Patil,R.S.; Pawar,B.V.; Shinde,U.S.; Bhalekar,M.N.; Kolse,R.H., 2008: Investigation of physical mutagene on M1 seed crop in onions. The M<sub>1</sub> onion seed bulbs obtained by treated with 10 kR gamma irradiation was evaluated for plant, floral and seed characteristics. The adverse effect of gamma radiation was observed especially on floral and seed parameters....

Mahdavi, G., 1991: Conditions for increasing fertilizer use. The point of view of an agricultural development officer. The increase in use of mineral fertilizers in intensive cotton cultivation in francophone Africa is discussed and the potential improvement of local over-exploited soils for other crops by mineral fertilizer application is considered with emphasis...

Nidecker, A.; Hartweg, H., 1983: Rare localizations of calcifying tendopathies. 5 case-reports illustrate 2 rare locations of calcifying peritendinitis: The insertion of the deltoid tendon in the proximal humerus and the insertion of the gluteus maximus tendon in the femur. Knowledge of these insertion sites on one hand and t...

Anonymous, 2007: Nick Lipley reports from this year's RCN emergency care association. NlmCategory="UNASSIGNED">Emergency nurses have been called on to 'involve and empower' patients so they can help develop new services.

Anonymous, 1970: Abortion incorporated. JAMA 214(2): 362-362