To what Extent can Results of Experimental Studies be Extrapolated in Predicting Adverse Side Effects of Drugs in Man?
A new potential antiinflammatory substance serves as an example that substantiates the necessity of carrying out concurrent comparative pharmacokinetic and biotransformation studies of new drugs in experimental animals and man during the preclinical research stage, with adherence to all safety precautions. Such a procedure will facilitate the choice of an animal model that approaches human metabolism and pharmacokinetics as closely as possible. This serves in the further development of the test drug, and thus enhances the validity of the transfer of experimental data to man, especially from the toxicological aspect.
Key wordsBenzofenac Toxicology Pharmacokinetics Biotransformation
Unable to display preview. Download preview PDF.
- Garret ER (1971) Pharmakokinetik. Das Medizinische Prisma, ed. Boehringer Ingelheim BRD: 1–20Google Scholar
- Jankü I, Roubal Z, Grimová J, Verner P, Némecek O (1981) Pharmacokinetic of benzofenac, new nonsteroidal antiinflammatory drug, in experimental animals and man. Ceskosl Farm 30: 93–102Google Scholar
- Jelínek R, Rychter Z (1979) Morphogenetic systems and the central phenomena of teratology. Advances in the study of birth defects TVN Persaud ed, MTP Press Lancaster 2: 41–67Google Scholar
- Koruna I, Ryska M, Roubal Z, Kuchaf M, Grimová J (1981) The metabolites of 4-benzyloxy-3-Cl-phenylacetic acid in the animals and man. Ceskosl Farm 30: 257–262Google Scholar
- Kuchaf M, Brdnovâ B, Rejholec V, Grimovâ J, Némecek O (1977) Substituted benzyloxyarylacetic acids: synthesis and quantitative relationships between structure and antiinflammatory activity. Coll Czech Chem Commun 42: 1723–1735Google Scholar