FDA (2004) ‘Draft Guidance for Industry. ANDAs: Pharmaceutical Solid Polymorphism. Chemistry, Manufacturing, and Controls Information’, 69 FR 75987–75988, 20th December, 2004, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0524-gdl0001.pdf.
2.
The public comment period was scheduled to end on 21st March, 2005.
3.
Guidance for industry, Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonisation (ICH), December 2000.
4.
ByrnS.R.PfeifferR.R.StowellJ.G. (1999) ‘Solid-State Chemistry of Drugs’, 2nd edn, SSCI, Inc., West Lafayette, IN.
5.
BrittainH.G.GrantD.J.W. (1999) ‘Effect of polymorphism and solid-state solvation on solubility and dissolution rate’, in BrittainH.G. (Ed.) ‘Polymorphism in Pharmaceutical Solids’, Marcel Dekker, Inc., New York, NY, pp. 279–330.
6.
Bioavailability (BA) is defined in 21 CFR 320.1(a) as: ‘The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action’. Bioequivalence (BE) is defined in 21 CFR 320.1(e) as ‘the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.’.
7.
Draft Guidance, lines 108–114.
8.
Section 505(j)(4)(A) provides that the FDA must approve an ANDA if, among other things, the methods used in, or the facilities and controls used for, the manufacture, processing and packing of the drug are adequate to assure and preserve its identity, strength, quality and purity.
9.
Draft Guidance, footnote 2.
10.
Draft Guidance, lines 10–12.
11.
See FDCA s. 505 (j)(2)(A) (same as 21 U.S.C. s. 355 (j)(2)(A)).
