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23 FDA: Waiver of in vivo bioavailability & bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system, in, 2000

24 McLachlan A: Personal communication

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30 WHO: Good Manufacturing Practices for pharmaceutical products: Main principles. Annex 4 in WHO Technical Report Series No. 908, 2003

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38 WHO (EDM): The International Pharmacopoeia, 2003

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40 ICH: Impurities in new drug substances (revised), http://www.ich.org, 2002

41 ICH: Impurities in new drug products (revised), www.ich.org, 2003

42 Various authors: Analytical profiles of drug substances & excipients, Academic Press, Various dates of publication