38. USP, USP 29–NF 24 (US Pharmacopeial Convention, Rockville, MD, 2006).
39. K.R. Morris et al., "An Integrated Approach to the Selection of Optimal Salt Form for a New Drug Candidate," Int. J. Pharm.
105 (3), 209–217 (1994).
40. R. Teraoka, M. Otsuka, and Y. Matsuda, "Effects of Temperature and Relative Humidity on the Solid-State Chemical Stability
of Ranitidine Hydrochloride," J. Pharm. Sci.
82 (6), 601–604 (1993).
41. H.Y. Ando and G.W. Radebaugh, "Preformulation," in Remington: The Science and Practice of Pharmacy, II, A.R. Gennaro, Ed. (Lippincott Williams and Wilkins, Baltimore, MD, 20th ed., 2002), pp. 700–720.
42. J.F. Remenar et al., "Salt Selection and Simultaneous Polymorphism Assessment via High-Throughput Crystallization: The
Case of Sertraline," Org. Proc. Res. Dev.
7 (6), 990–996 (2003).
43. C.R. Gardner, C.T. Walsh, and ö. Almarsson, "Drugs as Materials: Valuing Physical Form in Drug Discovery," Nat. Rev. Drug. Discov.
3 (11), 926–934 (2004).
44. "Ophthalmic/Otic Dosage Forms,"
http://www.cop.ufl.edu/safezone/prokai/pha5100/eye.htm, accessed Dec. 20, 2006.
45. Solvias, "Introduction: Solid-State Development,"
http://www.solvias.com/documents/Dokumente/Downloads_news/Solvias_Salt_and_Polymorphism_Programs.pdf, accessed Dec. 30, 2006.
46. European Agency for the Evaluation of Medicinal Products, "Note for Guidance on the Investigation of Bioavailability
and Bioequivalence" (EMEA, London, UK, 2001).
47. FDA, Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (FDA, Rockville, MD, 2000).
|
