Pharmacopeial harmonization in biotechnology.
There has been progress in the pharmacopeial harmonization initiative among the United States Pharmacopeia (USP), the European Pharmacopoeia and the Japanese Pharmacopoeia. Monographs on excipients and on biotechnology-derived products, as well as for General Chapters are progressing through the various stages of the harmonization process. An additional initiative, Concordance of Foreign Pharmacopeial Tests and Assays has been proposed by the USP.
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D001709:Biotechnology / Q000639:trends; D005060:Europe; D007564:Japan; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011643:Publishing; D014481:United States