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Drug interactions regulatory considerations

REGULATORY CONSIDERATIONS OF DRUG METABOLISM AND DRUG INTERACTION STUDIES... [Pg.203]

It is not hard to predict that with the output of genomics and proteomics, the number of proteins that can be related to specific diseases will increase tremendously in the next few years. Therefore methods that are able to screen combinatorial libraries in the search for interacting drugs are desperately required. Furthermore, efforts to re-examine known drugs for potential interactions with newly identified target proteins will increase, because it lowers costs considerably if a drug that has already passed the regulatory procedures can also be applied to cure a further disease. [Pg.245]

R., Hauck, W.W. et al., An individual bioequivalence criterion regnlatory considerations, Stat. Med. 19, 2821-2842, 2000 Meyer, M.C., United States Food and Drug Administration requirements for approval of generic drug products, J. Clin. Psychiatry 62 (Suppl. 5), 4-9, 2001 Temple, R., Policy developments in regulatory approval, Stat. Med. 21, 2939-3048, 2002 Gould, A.L, Substantial evidence of effect, J. Biopharm. Stat. 12, 53-77, 2002 Chen, M.L., Panhard, X., and Mentre, F, Evaluation by simulation of tests based on nonlinear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over clinical trials, Stat. Med. 24,1509-1524,2005 Bolton, S., Bioequivalence studies for levothy-roxine, AAPS J. 7, E47-E53, 2005. [Pg.225]


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Regulatory considerations

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