Handbook of pharmaceutical manufacturing formulations: Semisolid products (volume 4 of 6)

Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (Volume 4 of 6)

Volumn , Issue , 2004, Pages 1-265

  Niazi, Sarfaraz K ^a  

^a Pharmaceutical Scientist Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056035861     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book

References (74)

1. Bancroft, T.A., Analysis and inference for incompletely specified models involving the use of preliminary test(s) of significance, Biometrics, 20(3), 427–442, 1964.
2. Easterling, R.G., Discrimination intervals for percentiles in regression, J. Am. Stat. Assoc., 64, 1031–1041, 1969.
3. Fairweather, W.R., Lin, T.-Y.D., and Kelly, R., Regulatory, design, and analysis aspects of complex stability studies, J. Pharm. Sci., 84, 1322–1326, 1995.
4. Food and Drug Administration (FDA) Guideline, PAC-ATLS: Post Approval Changes: Analytical Testing Laboratory Sites, Center for Drug Evaluation and Research (CDER), April 1998.
5. FDA Guideline, SUPAC-MR, Modified Release Solid Oral Dosage Forms, Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, in vitro Dissolution Testing, in vivo Bioequivalence Documentation, CDER, September 1997.
6. FDA Guideline, Submission of Documentation in Drug Applications for Container Closure Systems used for the Packaging of Human Drugs and Biologics, CDER/CBER (Center for Biologics Evaluation and Research), draft guidance, July 1997.
7. FDA Guideline, SUPAC-SS, Non-Sterile SemiSolid Dosage Forms. Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, in vitro Release Testing, in vivo Bioequivalence Documentation, CDER, May 1997.
8. FDA Guideline, SUPAC-IR/MR: Immediate and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, draft guidance, April 1998.
9. FDA Guideline, SUPAC-IR, Immediate Release Solid Oral Dosage Form: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, in vitro Dissolution Testing, in vivo Bioequivalence Documentation, CDER, November 1995.
10. Haynes, J.D., Worldwide virtual temperatures for product stability testing, J. Pharm. Sci., 60(6), 927, 1971.
11. International Conference on Harmonisation (ICH), Q1A Stability Testing for New Drug Substances and Products, September 1994.
12. ICH, Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, July 1996.
13. ICH Guideline, Q1C Stability Testing for New Dosage Forms, November 1996.
14. ICH Guideline, Q1B Photostability Testing of New Drug Substances and Products, May 1997.
15. Lin, K.K., Lin, T.-Y.D., and Kelley, R.E., Stability of drugs: room temperature tests, in Buncher C.R. and Tsay J.-Y., Eds., Statistics in the Pharmaceutical Industry, Marcel Dekker, New York, 1994, p. 419–444.
16. U.S. Department of Health and Human Services, Public Health Service, FDA Guideline, Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endot-oxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices, December 1987.
17. Yoshioka, S. et al. Quinine actinometry as a method for calibrating ultraviolet radiation intensity in light-stability testing of pharmaceuticals, Drug Dev. Industrial Pharm., 20(13), 2049–2062, 1994.
18. Note: All references citing FDA or ICH or U.S. Department of Health and Human Services are available at http://www.fda.gov.
19. Carstensen, J.T., “Stability and Dating of Solid Dosage Forms,” Pharmaceutics of Solids and Solid Dosage Forms, Wiley-Interscience, New York, 1977, p. 182–185.
20. Ruberg, S.J. and Stegeman, J.W., Pooling data for stability studies: testing the equality of batch degradation slopes, Biometrics, 47, 1059–1069, 1991.
21. Ruberg, S.J. and Hsu, J.C., Multiple comparison procedures for pooling batches in stability studies, Techno-metrics, 34, 465–472, 1992.
22. Shao, J. and Chow, S.C., Statistical inference in stability analysis, Biometrics, 50, 753–763, 1994.
23. Murphy, J.R. and Weisman, D., Using random slopes for estimating shelf-life, Proc. Am. Stat. Assoc. Biopharm. Sect., 1, 196–200, 1990.
24. Yoshioka, S., Aso, Y., and Kojima, S., Assessment of shelf-life equivalence of pharmaceutical products, Chem. Pharm. Bull., 49, 1482–1484, 1997.
25. Chen, J.J., Ahn, H., and Tsong, Y., Shelf-life estimation for multi-factor stability studies, Drug Inf. J., 31, 573–587, 1997.
26. Fairweather, W., Lin, T.D., and Kelly, R., Regulatory, design, and analysis aspects of complex stability studies, J. Pharm. Sci., 84 (11), 1322–1326, 1995.
27. Berger, R.S. and Bowman, J.P., A reappraisal of the 21-day cumulative irritation test in man, J. Toxicol. Ot. Ocular Toxicol., 1(2), 109–115, 1982.
28. Holdiness, M.R., A review of contact dermatitis associated with transdermal therapeutic systems, Contact Dermatitis, 20(1), 3–9, 1989.
29. Lanman, B.M., Elvers, E.B., and Howard, C.J., The role of human patch testing in a product development program, Joint Conference on Cosmetic Sciences, The Toilet Goods Association (currently, the Cosmetic, Toiletry and Fragrance Association), Washington, D.C., April 21–23, 1968.
30. Patel, S.M., Patrick, E., and Maibach, H.I., Animal, human, and in vitro test methods for predicting skin irritation, in Dermatotoxicology, 5th ed., Marzulli, F.N. and Maibach, H.I., Eds., Taylor and Frances, 1977, chap. 33.
31. Smith, K.C., Ed., The Science of Photobiology, 2nd ed., Plenum Press, New York, 1989.
32. Kochevar, I.E., Pathak, M.A., and Parrish, J.A., Photo-physics, photochemistry, and photobiology, in Dermatology in General Medicine, Fitzpatrick, T.B., Eisen, A.Z., Wolff, K., Freedburg, I.M., and Austen, K.F., Eds., 4th ed., McGraw-Hill, New York, 1993, pp. 1627–1638.
33. Megaw, J.M. and Drake, L.A., Photobiology of the Skin and Eye, Marcel Dekker, New York, 1986.
34. Kornhauser, A., Wamer, W.G., and Lambert, L.A., Cellular and molecular events following ultraviolet irradiation of skin, in Dermatotoxicology, 5th ed., Taylor and Francis, Washington, DC, 1996, pp. 189–230.
35. Hessel, A., Siegle, R.J., Mitchell, D.L., and Cleaver, J.E., Xeroderma pigmentosum variant with multisystem involvement, Arch. Dermatol. 128(9), 1233–1237, 1992.
36. Kraemer, K.H., Lee, M.M., Andrews, A.D., and Lambert, W.C., The role of sunlight and DNA repair in melanoma and nonmelanoma skin cancer—the xeroderma pigmentosum paradigm, Arch. Dermatol., 130(8), 1018–1021, 1994.
37. Lindahl, T., Karran, P., and Wood, R.D., DNA excision repair pathways, Curr. Opin. Genet. Dev., 7(2), 158–169, 1997.
38. Holzle, E., Neumann, N., Hausen, B., Przybilla, B., Schauder, S., Honigsmann, H., Bircher, A., and Plewig, G., Photopatch testing: the 5 year experience of the German, Austrian, and Swiss Photopatch Test Group, J. Am. Acad. Dermatol., 25, 59–68, 1991.
39. Johnson, B.E., Light sensitivity associated with drugs and chemicals, Physiol. Pathophysiol. Skin, 8, 2542–2606, 1984.
40. Penn, I., Tumors of the immune compromised patient, Ann. Rev. Med. 39, 63–73, 1988.
41. Physicians’ Desk Reference, 54th ed., Medical Economics Co., Montvale, NJ, 2000.
42. Stern, R.S. and Lunder, E.J., Risk of squamous cell carcinoma and methoxsalen (psoralen) and UV-A radiation (PUVA). A meta-analysis, Arch. Dermatol., 134(12), 1582–1585, 1998.
43. Abel, E.A., Cutaneous manifestations of immunosup-pression in organ transplant recipients, J. Am. Acad. Dermatol., 21(2 part 1), 167–179, 1989.
44. Frezza, E.E., Fung, J., and van Thiel, D.H., Non-lym-phoid cancer after liver transplantation, Hepatogastro-enterology, 44(16), 1172–1181, 1997.
45. Gibbs, N.K., Young, A.R., and Magnus, I.A., Failure of UVR dose reciprocity for skin tumorigenesis in hairless mice treated with 8-methoxypsoralen, Photochem. Photobiol., 42(1), 39–42, 1985.
46. Moan, J., Dahlback, A., and Setlow, R.B., Epidemiological support for an hypothesis for melanoma induction indicating a role for UVA radiation, Photochem. Photobiol., 70(2), 243–247, 1999.
47. International Agency for Research on Cancer, Solar and ultraviolet radiation, IARC Monographs on the Evaluation of Carcinogenic Risk to Humans, Vol. 55, IARC, WHO, 1992.
48. Anderson, R.R. and Parrish, J. A., The optics of human skin, J. Invest. Dermatol., 77, 13–19, 1981.
49. Serup, J., Winther, A., and Blichmann, C., A simple method for the study of scale pattern and effects of a moisturizer—qualitative and quantitative evaluation by desquame tape compared with parameters of epidermal hydration, Clin. Experiment. Dermatol., 14, 277–282, 1989.
50. Marzulli, F.N. and Maibach, H.I., Eds., Dermatotoxicology, 4th ed., Taylor and Francis, New York, 1991, p. 585.
51. Baynes, R.E., Browne, C., Freeman, H., and Riviere, J.E., In vitro percutaneous absorption of benzidine in complex mechanistically defined chemical mixtures, Toxicol. Appl. Pharmacol., 141, 497–506, 1996.
52. Kaidbey, K. and Kligman, A., Topical photosensitizers: influence of vehicles on penetration, Arch. Dermatol., 110, 868–870, 1974.
53. Dearman, R.J., Cumberbatch, M., Hilton, J., Clowes, H.M., Fielding, I., Heylings, J.R., and Kimber, I., Influence of dibutyl phthalate on dermal sensitization to fluorescein isothiocyanate, Fundam. Appl. Pharmacol., 33, 24–30, 1996.
54. Asker, A.F. and Harris, C.W., Influence of certain additives on the photostability of physostigmine sulfate solutions, Drug Dev. Industrial Pharm., 14(5), 733–746, 1988.
55. Islam, M.S. and Asker, A.F., Photoprotection of dauno-rubicin hydrochloride with sodium sulfite, PDA J. Pharm. Sci. Technol., 49(3), 122–126, 1995.
56. Marti-Mestres, G., Fernandez, G., Parsotam, N., Niel-loud, F., Mestres, J.P., and Maillols, H., Stability of UV filters in different vehicles: solvents and emulsions, drug development industry, Pharmacy, 23(7), 647–655, 1997.
57. Wrench, R., Epidermal thinning: evaluation of commercial corticosteroids, Arch. Dermatol. Res., 267, 7–24, 1980.
58. Chaquor, B., Bellon, G., Seite, S., Borel, J.P., and Fourtanier, A., All trans-retinoic acid enhances collagen gene expression in irradiated and non-irradiated hairless mouse skin, J. Photochem. Photobiol. B: Biology, 37, 52–59, 1997.
59. Chellquist, E.M. and Gorman, W.G., Benzoyl peroxide solubility and stability in hydric solvents, Pharm. Res., 9(10), 1341–1346, 1992.
60. Becker, L., Eberlein-Konig, B., and Przybilla, B., Phototoxicity of non-steroidal antiinflammatory drugs: in vitro studies with visible light, Acta Derm. Venereol., 76(5), 337–340, 1996.
61. Navaratnam, S. and Claridge, J., Primary photophysical properties of ofloxacin, Photochem. Photobiol., 72(3), 283–290, 2000.
62. Marzulli, F.N. and Maibach, H.I., Photoirritation (phototoxicity, phototoxic dermatitis), in Dermatotoxicology, 5th ed., Marzulli, F.N. and Maibach, H.I., Eds., Taylor and Francis, New York, 1996, p. 231–237.
63. Marzulli, F.N. and Maibach, H.I., Eds., Dermatotoxicology Methods, Taylor and Francis, New York, 1998.
64. Lambert, L.A., Wamer, W.G., and Kornhauser, A., Animal models for phototoxicity testing, in Dermatotoxicology, 5th ed., Marzulli, F.N. and Maibach, H.I., Eds., Taylor and Francis, New York, 1996, pp. 515–529.
65. Spielmann, H., Balls, M., Dupuis, J., Pape, W.J., Pecho-vitch, G., et al., The international EU/COLIPA In Vitro Phototoxicity Validation Study: results of phase ii (blind trial): part 1: the 3T3 NRU phototoxicity test, Toxicol. In Vitro, 12(3), 305–327, 1998.
66. Jacobs, A., Avalos, J., Brown, P., and Wilkin, J., Does photosensitivity predict photococarcinogenicity? Int. J. Toxicol., 187(4), 191–198, 1999.
67. Learn, D.B., Sambuco, C.P., Forbes, P.D., and Hober-man, A.M., Phototoxicology: photocarcinogenesis historical control data as a key interpretative element, Toxicologist, 54(No. 1, pt. 2), 145, 2000.
68. Cosmetic Ingredient Review, Final report on the safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolate, methyl, ethyl, propyl, and butyl glycolate, and lactic acid, ammonium, calcium, potassium, sodium, and TEA-lactate, methyl, ethyl, iso-propyl, and butyl lactate, and lauryl, myristyl, and cetyl lactate, Int. J. Toxicol., 17(Suppl. 1), 1–241, 1998.
69. Burren, R., Scaletta, C., Frenk, E., Panizzon, R.G., and Applegate, L.A., Sunlight and carcinogenesis: expression of p53 and pyrimidine dimers in human skin following UVA I, UVA I +II and solar simulating radiations, Int. J. Cancer, 76, 201–206, 1998.
70. Lavker, R. and Kaidbey, K., The spectral dependence for UVA-induced cumulative damage in human skin, J. Invest. Dermatol., 108(1), 17–21, 1997.
71. Katiyar, S.K., Matsui, M.S., and Mukhtar, H., Kinetics of UV light-induced cyclobutane pyrimidine dimers in human skin in vivo: an immunohistochemical analysis of both epidermis and dermis, Photochem. Photobiol., 72(6), 788–793, 2000.
72. ICH, Guidance for Industry S1B Testing for Carcinogenicity of Pharmaceuticals. Available at: http://www.fda.gov/der/guidance/index.htm.
73. Johnson, B.E., Gibbs, N.K., and Ferguson, J., Quinolone antibiotic with potential to photosensitize skin tumorigenesis, J. Photochem. Photobiol. B: Biology, 37, 171–173, 1997.
74. FDA, Topical Dermatological Corticosteroids: In Vivo Bioequivalence, June 2, 1995. Van Buskirk, G.A., Shah, V.P., Adair, D., et al., Workshop report: scale-up of liquid and semi-solids disperse systems, Pharm. Res., 11, 1216– 1220, 1994.