Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition

Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition

Volumn , Issue , 2009, Pages 1-648

  Bolton, Sanford ^a   Bon, Charles ^b  

^a Biostudy Solutions LLC ^*  (United States)

^b Biostudy Solutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85132472291     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9781420074239     Document Type: Book

References (185)

1. Berkow R. The Merck Manual, 14th ed. Rahway, NJ: Merck Sharp & Dohme Research Laboratories, 1982.
2. Tukey J. Exploratory Data Analysis. Reading, MA: Addison-Wesley, 1977.
3. Yule GU, Kendall MG. An Introduction to the Theory of Statistics, 14th ed. London: Charles Griffin, 1965.
4. Sokal RR, Rohlf FJ. Biometry. San Francisco, CA: W.H. Freeman, 1969.
5. Colton T. Statistics in Medicine. Boston, MA: Little, Brown, 1974.
6. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
7. United States Pharmacopeia, 9th Supplement. Rockville, MD: USP Convention, Inc., 1990:3584–3591.
8. Graham SJ, Lawrence RC, Ormsby ED, et al. Particle Size Distribution of Single and Multiple Sprays of Salbutamol Metered-Dose Inhalers (MDIs). Pharm Res 1995; 12:1380.
9. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy, 3rd ed. Philadelphia, PA: Lea & Febiger, 1986.
10. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989.
11. Rothman ED, Ericson WA. Statistics, Methods and Applications. Dubuque, IA: Kendall Hunt, 1983.
12. Fisher RA. Statistical Methods for ResearchWorkers, 13th ed. New York, Hafner, 1963.
13. Schmid CF. Statistical Graphics. New York:Wiley, 1983.
14. Tufte ER. The Visual Display of Quantitative Data. Chelshire, CT: Graphics Press, 1983.
15. Gibaldi M, Perrier D. Pharmacokinetics, 2nd ed. New York: Marcel Dekker, 1982.
16. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
17. Hald A. Statistical Theory and Engineering Applications. New York: Wiley, 1965.
18. United States Pharmacopeia, 23rd Rev., and National Formulary, 18th ed. Rockville, MD: USP Pharmacopeial Convention, Inc., 1995.
19. Ostle B. Statistics in Research, 3rd ed. Ames, IA: Iowa State University Press, 1981.
20. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
21. Feller W. Probability Theory and Its Applications. Wiley and Sons, NY:Wiley, 1950:218.
22. http://en.wikipedia.org/wiki/Negativebinomialdistribution.
23. Stockham JD, Fochtman EG, eds. Particle Size Analysis. Ann Arbor, MI: Ann Arbor Science, 1977.
24. Jillavenkatesa A, Dapkunas S, Lum LH. Particle Size Characterization. Washington, D.C.: Material Science and Engineering Laboratory, U.S. Department of Commerce, National Institute of Standards and Technology, 2001:960–961.
25. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989.
26. The Rand Corporation. A Million Random Digits with 100,000 Normal Deviates. New York: The Free Press, 1966.
27. Cochran WG. Sampling Techniques, 3rd ed. New York:Wiley, 1967.
28. Stuart A. Basic Ideas of Scientific Sampling. London: Charles Griffith & Co., Ltd., 1976.
29. Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics 1976; 32:741–744.
30. Westlake WJ. Bioavailability and bioequivalence of pharmaceutical formulations. In: Peace KE, ed. Statistical Issues in Drug Research and Development. New York: Marcel Dekker, 1990.
31. Snedecor GW, Cochran WG. Statistical Methods, 6th ed. Ames, IA: Iowa State University Press, 1967.
32. Cochran WG. Sampling Techniques, 3rd ed. New York:Wiley, 1967.
33. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989.
34. D’Agostino RB, Chase W, Belanger A. The appropriateness of some common procedures for testing the equality of two independent binomial populations. Am Stat 1988; 42:198
35. Fleiss J. Statistical Methods for Rates and Proportions, 2nd ed. New York:Wiley, 1981.
36. Hauck W, Anderson S. A comparison of large sample CI methods for the difference of two binomial probabilities. Am Stat 1986; 40:318.
37. Cowdery S, Michaels T. Pharmacopeial Forum. 1980:614.
38. United States Pharmacopeia, 23rd rev, and National Formulary, 18th ed. Rockville, MD: USP Pharmacopeial Convention, Inc., 1995.
39. U.S. Department of Defense Military Standard. Military Sampling Procedures and Tables for Inspection by Attributes (MIL-STD-105E). Washington, DC: U.S. Government Printing Office, 1989.
40. Guenther WC. Sample size formulas for normal theory tests. Am Stat 1981; 35:243.
41. Fleiss J. Statistical Methods for Rates and Proportions, 2nd ed. New York:Wiley, 1981.
42. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
43. Phillips KE. Power of the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1991; 18:137.
44. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, 1992.
45. Dilletti E, Hauschke D, SteinijansVW. Sample size determination: Extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43. Int J Clin Pharmacol Toxicol 1991; 29:1.
46. Draper NR, Smith H. Applied Regression Analysis, 2nd ed. New York:Wiley, 1981.
47. Youden WJ. Statistical Methods for Chemists. New York:Wiley, 1964.
48. U.S. Food and Drug Administration. Current Good Manufacturing Practices (CGMP) 21 CFR. Washington, DC: Commissioner of the Food and Drug Administration, 2006:210–229.
49. Davies OL, Hudson HE. Stability of drugs: Accelerated storage tests. In: Buncher CR, Tsay J-Y, eds. Statistics in the Pharmaceutical Industry. New York: Marcel Dekker, 1994:445–479.
50. Tootill JPR. A critical appraisal of drug stability testing methods. J Pharm Pharmacol 1961; 13(suppl): 75T–86T.
51. Davis J. The Dating Game. Washington, DC: Food and Drug Administration, 1978.
52. Norwood TE. Statistical analysis of pharmaceutical stability data. Drug Dev Ind Pharm 1986; 12:553–560.
53. International Conference on Harmonization Bracketing and matrixing designs for stability testing of drug substances and drug products (FDA Draft Guidance) Step 2, Nov 9, 2000.
54. Nordbrock ET. Stability matrix designs. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics. New York: Marcel Dekker, 2000:487–492.
55. Murphy JR. Bracketing Design. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics. New York: Marcel Dekker, 2000:77.
56. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989.
57. Weisberg S. Applied Linear Regression. New York:Wiley, 1980.
58. duToit SHC, Steyn AGW, Stumpf RH. Graphical Exploratory Data Analysis. New York: Springer, 1986.
59. Shah VP, Prasad VK, Alston T, et al. In vitro in vivo correlation for 100 mg phenytoin sodium capsules. J Pharm Sci 1983; 72:306.
60. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989.
61. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
62. Scheff´e H. The Analysis of Variance. New York:Wiley, 1964.
63. Dunnett C, Goldsmith C. When and How to do multiple comparisons. in: Buncher CR, Tsay J-Y, eds. Statistics in the Pharmaceutical Industry, 2nd ed. New York: Marcel Dekker, 1993:481–512.
64. Steel RGD, Torrie JH. Principles and Procedure of Statistics. New York: McGraw-Hill, 1960.
65. Dubey SD. Adjustment of P-values for multiplicities of Intercorrelating Symptoms. In: Buncher CR, Tsay J, eds. Statistics in the Pharmaceutical Industry, 2nd ed. New York: Marcel Dekker, 1993:513–528.
66. Comelli M. Multiple Endpoints. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics, Multiple Endpoints. New York: Marcel Dekker, 2000:333–344.
67. Snedecor GW, Cochran WG. Statistical Methods, 8th ed. Ames, IA: Iowa State University Press, 1989:273.
68. Permutt T. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics, Adjustments for Covariates. New York: Marcel Dekker, 2000:1–3.
69. FDA Stability Program, Moh-Jee Ng, Div. of Biometrics, Center for Drug Evaluation and Res., FDA 1992.
70. Davies OL. The Design and Analysis of Industrial Experiments. New York: Hafner, 1963.
71. Chariot M, Frances GA, Lewis D, et al. A factorial approach to process variables of extrusionspheronisation of wet powder masses. Drug Dev Ind Pharm 1987; 13(9–11):1639–1649.
72. Beyer WH, ed. Handbook of Tables for Probability and Statistics. Cleveland, OH: The Chemical Rubber Co., 1966.
73. Box GE, Hunter WG, Hunter JS. Statistics for Experimenters. New York:Wiley, 1978.
74. Plaizier-Vercammen JA, De Neve RE. Interaction of povidone with aromatic compounds II: Evaluation of ionic strength, buffer concentration, temperature, and pH by factorial analysis. J Pharm Sci 1981; 70:1252.
75. Bolton S. Factorial designs in pharmaceutical stability studies. J Pharm Sci 1983; 72:362.
76. Ahmed S, Bolton S. Factorial design in the study of the effects of selected liquid chromatographic conditions on resolution and capacity factors. J Liq Chromatogr 1990; 13:525.
77. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, 1992:18.
78. Mosteller F, Youtz C. Tables of the Freeman–Tukey transformations for the binomial and Poisson distributions. Biometrika 1961; 48:433–440.
79. Sokal RR, Rohlf FJ. Biometry. San Francisco, CA: W. H. Freeman, 1969.
80. Weisberg S. Applied Linear Regression. New York:Wiley, 1980.
81. Ostle B. Statistics in Research, 3rd ed. Ames, IA: Iowa State University Press, 1981.
82. Youden WJ. Statistical Methods for Chemists. New York:Wiley, 1964.
83. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
84. E-178–75, American National Standards Institute, Z1.14, 1975, p. 183.
85. Barnett V, Lewis T. Outliers in Statistical Data, 2nd ed. New York:Wiley, 1984.
86. Bolton S. Outlier tests and chemical assays. Clin Res Practices Drug Reg Affairs 1993; 10:221–232.
87. Lund RE. Tables for an approximate test for outliers in linear regression. Technometrics 1975; 17(4):473–476.
88. SAS Institute, Inc., Cary, N.C. 27513.
89. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, 1992:280.
90. Department of Health, Education and Welfare. General Considerations for the Clinical Evaluation of Drugs (GPO 017–012–00245–5) (Pub. HEW (FDA) 77–3040). Washington, D.C.: FDA Bureau of Drugs Clinical Guidelines, U.S. Government Printing Office, 1977.
91. Cox DR. Planning Experiments. New York:Wiley, 1958.
92. Rodda BE, Tsianco MC, Bolognese JA, et al. Clinical Development. In: Peace KE, ed. Statistical Issues in Drug Research and Development. New York: Marcel Dekker, 1990.
93. Buncher CR, Tsay J-Y. Statistics in the Pharmaceutical Industry, 2nd ed. New York: Marcel Dekker, 1994.
94. Fisher LD, et al. Intention to treat in clinical trials. In: Peace KE, ed. Statistical Issues in Drug Research and Development. New York: Marcel Dekker, 1990: 331–349.
95. Snedecor GW, Cochran WG. Statistical Methods, 7th ed. Ames, IA: Iowa University Press, 1980.
96. Brown BW Jr. The crossover experiment for clinical trials. Biometrics 1980; 36:69.
97. Cochran WG, Cox GM. Experimental Designs, 2nd ed. New York: Wiley, 1957.
98. Grizzle JE. The two-period change-over design and its use in clinical trials. Biometrics 1965; 21:467, 1974; 30:727.
99. Guidance for Industry (Draft). Bioavailability and Bioequivalence Studies for Orally Administered Drug Products, General Considerations. Rockville, MD: FDA, CDER, 2003.
100. Haynes JD. Change-over design and its use in clinical trials. J Pharm Sci 1981; 70:673.
101. Schuirman DL. On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval. Biometrics 1981, 37:617.
102. FDA bioavailability/bioequivalence regulations. Fed Regist 1977; 42:1624.
103. FDA. Guidance for Industry, Appendix V. New York: Center for Drug Evaluation and Research, 1997.
104. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker, 1992:280.
105. Schuirman DL. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15:657–680.
106. Westlake WJ. Bioavailability and bioequivalence of pharmaceutical formulations. In: Peace KE, ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker, 1988:329–351.
107. Phillips KE. Power of the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1990; 18:137.
108. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1991; 29(1):1.
109. Boddy AW, Snikeris FC, Kringle RO, et al. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm Res 1995; 12:1865.
110. Committee For Proprietary Medicinal Products (CPMP). Note for Guidance on the Investigation of Bioavailability and Bioequivalence. London: The European Agency for the Evaluation of Medicinal Products, Evaluation of Medicines for Human Use, 2001.
111. Tothfalusi L, Endrenyi L, Midha KK, et al. Evaluation of the bioequivalence of highly variable drugs and drug products. Pharm Res 2001; 18:728.
112. Jones G, Kenward MG. Design and Analysis of Cross-over Trials. London: Chapman and Hill, 1989.
113. Sankoh AJ. Interim analyses: An update of an FDA reviewer’s experience and perspective. Drug Inf J 1995; 29:729.
114. Hyslop T, Hsuan F, Hesney M. A small sample confidence interval approach to assess individual bioequivalence. Stat Med 2000; 19:2885–2897.
115. Eckbohm, Melander H. The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics 1989; 45:1249–1254.
116. US Department of Health and Human Services. Statistical Approaches to Establishing Bioequivalence. Rockville, MD: FDA CDER, 2001.
117. Makuch R, Simon R. Sample size requirements for evaluating a conservative therapy. Cancer Treat Rep 1978; 62(7):1037.
118. Haidar SH, et al. Pharm Res 2008; 25:237–240.
119. Chinchilli VM. Clinical efficacy trials with quantitative Data. In: Peace KE, ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker, 1988:353–394.
120. Winer BJ. Statistical Principles in Experimental Design, 2nd ed. New York: McGraw-Hill, 1971.
121. Davis R, Huang I. Interim analysis. In: Buncher CR, Tsay J-Y, eds. Statistics in the Pharmaceutical Industry, 2nd ed. New York: Marcel Dekker, 1994:267–285.
122. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549.
123. Summary from “Issues with Interim Analysis in the Pharmaceutical Industry,” The PMA Biostatistics and Medical Ad Hoc Committee on Interim Analysis, 1990.
124. Berry DA. Statistical Methodology in the Pharmaceutical Sciences. NewYork: Marcel Dekker, 1990:294.
125. Geller N, Pocock S. Design and analysis of clinical trials with group sequential stopping rules. In: Peace KE, ed. Biopharmaceutical Statistics for Drug Development. New York: Marcel Dekker, 1988, Chapter 11.
126. Hauck WH, Anderson S. Measuring switchability and prescribability: When is average bioequivalence sufficient? J Pharmacokinet Biopharm 1994; 22:551.
127. Grant EL. Statistical Quality Control, 4th ed. New York: McGraw-Hill, 1974.
128. Duncan AJ. Quality Control and Industrial Statistics, 5th ed. Homewood, IL: Irwin, 1986.
129. U.S. Department of Defense. MIL-STD-105E, Military Sampling Procedures and Tables for Inspections by Attributes. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1989.
130. Allen PV, Dukes GR, Gerger ME. Determination of release limits: A general methodology. Pharm Res 1991; 8:1210.
131. U.S. Department of Defense. MIL-STD-414, Sampling Plans. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1989.
132. Haynes JD, Pauls J, Platt R. Statistical Aspects of a Laboratory Study for Substantiation of theValidity of an Alternate Assay Procedure, “The Green-Briar Procedure.” Final Report of the Standing Committee on Statistics to the PMA/QC Section, March 14, 1977.
133. Youden WJ. Statistical Methods for Chemists. New York:Wiley, 1964.
134. Mandel J. The Statistical Analysis of Experimental Data. New York: Interscience, 1964.
135. Bennet CA, Franklin NL. Statistical Analysis in Chemistry and the Chemical Industry. New York: Wiley, 1963.
136. Steel R, Torrie J. Principles and Procedures of Statistics. New York: McGraw-Hill Book Co., Inc., 1960.
137. United Stales v. Barr Labs, Inc., Consolidated Docket No. 92–1744 (AMW).
138. Bergum J, Utter M. Process validation. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics. New York: Marcel Dekker, 2000:422–440.
139. US Dept of Health and Human Services, FDA, CDER, 1997.
140. United States Pharmacopeia, 23, 1995 pp. 1791–1793.
141. Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production US Dept of Health and Human Services, FDA, CDER, Sept 1998.
142. Box GE, Hunter WG, Hunter JS. Statistics for Experimenters. New York:Wiley, 1978.
143. Guideline of General Principles of Process Validation. Rockville, MD: FDA, 1991.
144. Berry IR. Process validation: Practical applications to pharmaceutical products. Drug Dev Ind Pharm 1988; 14:377.
145. Berry IR, Nash R. Pharmaceutical Process Validation. New York: Marcel Dekker, 1993.
146. Nash R. In: Lieberman HA, Lachman L, Schwartz J, eds. Pharmaceutical Dosage Forms: Tablets, Vol 3, 2nd ed. New York: Marcel Dekker, 1990.
147. United States v. Barr Labs., Inc., Consolidated Docket No. 92–1744 (AMW) (Court Ruling 2/4/93).
148. Plackett RL, Burman J P. The design of optimum multifactorial experiments. Biometrika 1946; 33:305–325.
149. Lang JR, Bolton S. A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry, Part I. J Pharm Biomed Anal 1991; 9:357.
150. Lang JR, Bolton S. A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry–2. Statistical analyses. J Pharm Biomed Anal 1991; 9:435.
151. Schofield T. Assay validation. In: Chow S-C, ed. Encyclopedia of Pharmaceutical Statistics. New York: Marcel Dekker, 2000:21–30.
152. Mooney CZ, Duval RD. Bootstrapping:ANonparametric Approach to Statistical Inference. Newbury Park, CA: Sage University Paper Series on Quantitative Applications in the Social Sciences, Sage Publications, Inc., 1993.
153. Blank S, Seiter C, Bruce P. Resampling Stats in Excel. Arlington, VA: Resampling Stats, Inc., 1999.
154. Simon JL. Resampling: The New Statistics, 2nd ed. Arlington, VA: Resampling Stats, Inc., 1998.
155. Simon JL. Resampling Stats: User’s Guide. Arlington, VA: Resampling Stats, Inc., 1999.
156. Snedecor GW, Cochran WG. Statistical Methods, 7th ed. Ames, IA: State University Press, 1980.
157. Wilcoxon F, Wilcox RA. Some Rapid Approximate Statistical Procedures. Pearl River, NY: Lederle Laboratories, 1964.
158. Hollander M, Wolfe DA. Nonparametric Statistical Methods. New York:Wiley, 1973.
159. Steinijens VW, Diletti E. Statistical analysis of bioavailability studies: Parametric and nonparametric confidence intervals. Ear J Clin Pharmacol 1983; 24:127–136.
160. Jones B, Kenward MC. Design and Analysis of Cross-Over Trials. London: Chapman and Hall, 1989.
161. Cornell RG. Evaluation of bioavailability data using nonparametric statistics. In: Albert KS, ed. Drug Absorption and Disposition, Statistical Considerations. Washington, DC: American Pharmaceutical Association, Academy of Pharmaceutical Sciences, 1980:51.
162. Koch G. The use of nonparametric methods in the statistical analysis of the two period change-over design. Biometrics 1972; 28:577–584.
163. Wallenstein S, Fisher AC. The analysis of the two-period repeated measurements crossover design with application to clinical trails. Biometrics 1977; 33:261.
164. Conover W. Practical Nonparametric Statistics, 2nd ed. New York: JohnWiley and Sons, 1980.
165. Sprent P. Applied Nonparametric Statistical Methods. New York: Chapman and Hall, 1989.
166. Quade D. J Am Stat Assoc 1967:1187.
167. Sokal RR, Rohlf FJ. Biometry. San Francisco:W.H. Freeman, 1969.
168. Fleiss JL. Statistical Methods for Rates and Proportions. New York:Wiley, 1980.
169. Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis, 3rd ed. New York: McGraw-Hill, 1969.
170. Koch GG, Edwards S. Summarization analysis, and monitoring of adverse experiences. In: Peace KE, ed. Statistical Issues in Drug Research and Development. New York: Marcel Dekker, 1990: 19–161.
171. Mantel N, HaenszelW. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Canc Inst 1959; 22:719.
172. Sprent P. Applied Nonparametric Statistical Methods. New York: Chapman and Hall, 1989:128.
173. Rice JA. Mathematical Statistics and Data Analysis. Pacific Grove, CA:Wadsworth and Brooks/Cole, Statistics/Probability Series, 1988.
174. Davies OL. The Design and Analysis of Industrial Experiments. New York: Hafner, 1963.
175. Ahmed S, Bolton S. Factorial design in the study of the effects of selected liquid chromatographic conditions on resolution and capacity factors. J Liq Chromatogr 1990; 13:525.
176. Daniel C. Use of half normal plots in interpreting factorial two-level experiments. Technometrics 1959; 1:311.
177. Box GE, Hunter WG, Hunter JS. Statistics for Experimenters. New York:Wiley, 1978.
178. Schwartz JB, Flamholtz JR, Press RH. Computer optimization of pharmaceutical formulations. I. General procedure. J Pharm Sci 1973; 62:1165.
179. Fonner DE Jr, Buck JR, Banker GS. Mathematical optimization techniques in drug product design and process analysis. J Pharm Sci 1970; 59:1587.
180. Lindberg N-O, Jonsson C, Holmquist B. Optimization of disintegration time and crushing strength of a tablet formulation. Drug Dev Ind Pharm 1985; 11(4):931–943.
181. Box GEP, Draper NR. Evolutionary Operations. New York:Wiley, 1969.
182. Spendley W, Hext GR, Himsworth FR. Sequential application of simplex designs in optimization and evolutionary operation. Technometrics 1962; 4:441.
183. Nelder JA, Mead R. A simplex method for function minimization. Comput J 1965; 7:308.
184. Shek E, Ghani M, Jones RE.Anew attempt to solve the scale-up problem for granulation using response surface methodology. J Pharm Sci 1980; 69:1135.
185. Gorman JW, Hinman JE. Simplex lattice designs for multicomponent systems. Technometrics 1962; 4:463.