Literature DB >> 11032086

Japanese guidance on bioavailability and bioequivalence.

N Aoyagi1.   

Abstract

The guideline of bioequivalence tests for generic drugs in our country was recently revised (1), and guidelines for formulation change and different strengths were published in February 2000. This paper describes those guidelines briefly.

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Year:  2000        PMID: 11032086     DOI: 10.1007/BF03190053

Source DB:  PubMed          Journal:  Eur J Drug Metab Pharmacokinet        ISSN: 0378-7966            Impact factor:   2.441


  1 in total

1.  Bioavailability of sugar-coated tablets of thiamine disulfide in humans. I. Effect of gastric acidity and in vivo-in vitro correlation.

Authors:  N Aoyagi; H Ogata; N Kaniwa; M Koibuchi; T Shibazaki; A Ejima; M Mizobe; K Kohno; M Samejima
Journal:  Chem Pharm Bull (Tokyo)       Date:  1986-01       Impact factor: 1.645

  1 in total
  1 in total

1.  Bioequivalence testing by statistical shape analysis.

Authors:  Luis Marcelo Pereira
Journal:  J Pharmacokinet Pharmacodyn       Date:  2007-06-07       Impact factor: 2.410

  1 in total

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