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Fairweather, WR. Evaluation of alternative approaches to preliminary testing in stability studies with missing data. In preparation

_____________ Calculating the expiration dating period of a stability study that includes missing values. In preparation.

_____________ The imputers model:Different model possibilities with the same data and how to proceed. In preparation.

_____________ A computer-assisted, multiple-choice approach to learning Japanese kanji. Submitted for publication.

Fairweather WR. (2013). Preliminary testing in multifactor stability studies. Statist. Biopharm. Research, 5(4), 338-344.

________________(2012). Rejoinder to Buck and Altan, J. Biopharm. Statistics, 22(01), 211-212.

_____________ (2012). Corrigenda, J. Biopharm. Statistics, 22(01), 221-221.

_____________ (2011). Ambiguous assignment of release values in stability studies. Jnl Biopharm Statist. 21(03), 453-471.

Murugesan, SR; King, CR; Osborn, R; Fairweather, WR; O’Reilly, EM; Thornton, MO; and Wei, LL. (2009) Combination of human tumor necrosis factor-alpha gene delivery with gemcitabine is effective in models of pancreatic cancer, Cancer Gene Therapy, 1-7.

Posner, M; Chang, KJ; Stephenson, J; Khan, M; Reid, T; Fisher, W; Thornton, M; Kovacevic, M; Fairweather, W; Thompson J; Rosemurgy, A. Multi-center Phase II/III Randomized Controlled Clinical Trial using TNFerade(tm) gene delivery combined with chemoradiation in patients with locally advanced pancreatic cancer: Interim survival analysis trend favors TNFerade(tm). Cancer Gene Therapy 16, 841-847 (November 2009) | doi:10.1038/cgt.2009.32

Thompson, R; Ackerman, SJ; Watrous, RL. (2008) The impact of computer-assisted auscultation on physician referrals of asymptomatic patients with heart murmurs. (Statistical contribution by Fairweather, W). Clin. Cardiol. 31(2),79-83.

Fairweather WR (2005). An application of the Mantel-Haenszel statistic in process validation. J. Biopharm. Statist. 15 253-264.

__________ (2003). A quantitative assessment of factors influencing the probability of Postmarketing out-of-specification observations. J.Biopharm.Statist. 13(3) 415-423.

__________, R Mogg, PS Bennett, J Zhong, C Morrissey, and TL Schofield (2003). Monitoring the stability of human vaccines. J.Biopharm.Statist. 13(3) 395-413.

__________ (2001). Comments on ICH Q1D. Position paper submitted to rapporteur of International Conference on Harmonisation.

Knatterud, GL, F Rockhold, SL George, FB Barton, CE Davis, WR Fairweather, T Honohan, R Mowery and RT O'Neill (1998). Guidelines for quality assurance in multicenter trials: A position paper. Controlled Clinical Trials, 19(5) 477-493.

Fairweather, WR and TY Lin (1998). Statistical and Regulatory Aspects of Drug Stability Studies. Chapter 5 of International Stability Guidelines, edited by D Mazza, Buffalo Grove IL: Interpharm Press, Inc.

__________ (1998). FDA review. Panel discussion in Workshop on Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision- Making. Institute of Medicine of National Academy of Sciences.

___________, A Bhattacharyya, PP Ceuppens, G Heimann, LA Hothorn, RL Kodell, KK Lin, H Mager, BJ Middleton, W Slob, KA Soper, N Stallard, J Ventre, J Wright (1998). Biostatistical methodology in carcinogenicity studies. Drug Information Journal,32(2):401-421.

Contrera, J, A Jacobs, J DeGeorge, CH Chen, JB Choudary AF DeFelice, WR Fairweather, et al. (1998) Carcinogenicity testing and the evaluation of regulatory requirements, Virtual Journal of the Center for Drug Evaluation & Research, 1.

Fleming, GA, WR Fairweather, JG Levine and J Woodcock. (1998) FDA review of the metformin New Drug Application, Virtual Journal of the Center for Drug Evaluation & Research, 1.

Fairweather, WR (1996). Integrated safety analysis: Statistical issues in the assessment of safety in clinical trials. Drug Information Journal, 30, 875-9.

___________ (1996). Regulatory, design and analysis aspects of complex stability studies - A US perspective. Invited paper presented at conference on Stability Testing - Design and Interpretation of Data for International Registration of Pharmaceuticals for Human and Veterinary Use. London, Great Britain.

___________ (1996). Issues in carcinogenicity analyses - An FDA perspective. Invited paper presented at Drug Information Association Workshop on Statistical Methodology in Nonclinical and Toxicological Studies, Brugge Belgium.

___________ (1995). Integrated safety analysis: Statistical issues in the assessment of safety in clinical trials. Paper presented at 31st Annual Drug Information Association meeting. Orlando FL.

___________, D Lin and R Kelly (1995). Regulatory, design and analysis aspects of complex stability studies. J.Pharm.Sci. 84 no 11., 1322-1326.

DeMets, DL, D Anbar, WR Fairweather, TA Louis and RT O'Neill (1995). Training the next generation of biostatisticians. The American Statistician, 48, 280-5.

Fairweather, WR (1994). TQM in Drug Development. Discussant for three papers at American Statistical Association Winter Meeting, Atlanta GA.

___________ (1994). Design of Stability Studies: FDA Statistical Perspective. Invited paper presented at American Association of Pharmaceutical Scientists Workshop on Stability Guidelines for Testing Pharmaceutical products, Arlington VA.

___________ (1994). Statistical analysis of stability data according to the new requirements. Invited paper presented at conference on Statistical Testing - Design & Interpretation of Data for International Registration of Pharmaceuticals, London, Great Britain. Also presented at Medicines Control Agency, Department of Health, London.

___________ (1994). Statistical Issues of Chemistry and Manufacturing Controls. Discussant for four papers at Joint Meetings of the American Statistical Association, Toronto Canada.

___________ and SD Dubey (1994). Statisticians, the FDA and a time of transition. Keynote address presented at Pharmaceutical Manufacturer's Association Education and Research Institute course in Non-Clinical Statistics, Washington DC.

___________, D Lin and R Kelly (1994). Regulatory and design aspects of complex stability studies. Presented at the Pharmaceutical Research and Manufacturers of America Biostatistics Subsection/Clinical Data Management Group Joint Meeting, Washington DC.

___________ and SD Dubey (1993). Statisticians, the FDA and a time of transition. Keynote address presented at Pharmaceutical Manufacturer's Association Education and Research Institute course in Non-Clinical Statistics, Washington DC.

___________ and RT O'Neill (1993). Training the next generation of biostatisticians - A view from Government. Presented at Joint Meeting of the Biometric Society, ENAR. Philadelphia PA.

___________ (1992). TQM at FDA. Invited paper presented at the national meeting of the American Statistical Association, Boston MA.

___________ and SD Dubey (1992). Statisticians, the FDA and a changing world. Keynote address presented at Pharmaceutical Manufacturer's Association Education and Research Institute course in Non-Clinical Statistics, Washington DC.

___________ (1991). Does "one size fits all" apply to animal carcinogenicity studies? Paper presented at Regulatory Affairs Professional Society meeting on International Toxicology Guidance: Scientific and Regulatory Aspects. Lucca, Italy.

___________ and DJ Schuirmann (1991). Outliers in bioequivalence studies - Should they be included? Paper presented at the Drug Information Association workshop on Bioavailability/ Bioequivalence: Pharmacokinetic and Statistical Considerations. Bethesda MD.

Lin, D and WR Fairweather (1991). Experimental design assumptions for alternative stability studies. Paper presented and the annual meeting of the Pharmaceutical Manufacturers Association Biostatistics Subsection. Alexandria VA.

Dubey, SD and WR Fairweather (1991). The FDA and its structure. Paper presented at Pharmaceutical Manufacturer's Association Education and Research Institute course in Non-Clinical Statistics, Washington DC.

Fairweather, WR (1989). Computer assisted review of tumorigenicity studies. Paper presented at 25th Annual Drug Information Association meeting. Boston MA.

___________ (1989). Statistical issues in the evaluation of biological growth factors. Paper presented at 25th Annual Drug Information Association meeting. Boston MA.

___________ (1988). Computer-Assisted NDA Review of toxicology and pharmacology data. Paper presented at Joint PMA/FDA-sponsored meeting on CANDAR. Baltimore MD.

___________ (1988). Statistical considerations in tumorigenicity study review. Paper presented at 24th Annual Drug Information Association meeting. Toronto, Canada.

Temple, R, WR Fairweather, V Glocklin, RT O'Neill (1988). The case for blinded slide reading. Comments Toxicology, 2, 99-109.

Fairweather, WR (1987). Comparing proportion exposed in case-control studies using several control groups. Am. J. Epid, 126 No 2, 170-178.

___________ (1987). Analysis of multiple tumors in carcinogenicity studies. Paper presented at Tenth Annual Midwest Biopharmaceutics Workshop, Muncie IN.

___________ (1987). The future of statistics. Paper presented at Tenth Annual Midwest Biopharmaceutics Workshop, Muncie IN.

___________ (1987). Estimating changes in bioavailability due to generic substitution of drugs. Paper presented at the annual meeting of the American Statistical Association, San Francisce CA.

Hurwitz, ES, MJ Barrett, WJ Gunn, D Bregman, P Pinsky, LB Schonberger, JS Drage, RA Kaslow, DB Burlington, GV Quinnan, JR LaMontagne, WR Fairweather, D Dayton, WR Dowdle (1987). Public Health Service Study of Reye Syndrome and medications--Report of the main study. JAMA, 257 No 14, 1905-1911.

Fairweather, WR (1986). Statistical considerations for data format and analysis: An FDA perspective. Paper presented at the Drug Information Association meeting on Organization of Nonclinical Data for Effective Evaluation, Bethesda MD.

___________ and Rastogi SC (1986). General considerations for the review of animal tumorigenicity studies. Paper presented at the annual meeting of the Biostatistics Subsection of the Pharmaceutical Manufacturers Association, Washington, DC.

Shah, VP, JP Hunt, WR Fairweather, VK Prasad, and G Knapp (1986). Influence of dioctyl sodium sulfosuccinate on the absorption of tetracycline. Biopharmaceutics & Drug Disposition 7, 27-33.

Fairweather WR (l985). Current issues in the interpretation of animal tumorigenicity studies. Invited paper (welcoming address) presented at the Symposium on Long-term Animal Carcinogenicity Studies--A Statistical Perspective, Bethesda MD.

___________ (l985). Multiple comparisons in retrospective studies. Paper presented at the Spring Regional Meetings, Biometric Society, Raleigh NC.

___________ (1985). Comparing proportion exposed in case-control studies using several control groups. Paper presented at the International Conference on Foundations of Statistical Inference, Tel Aviv, Israel.

___________ and Harris ND (l985). Performance of Peto's test statistics in simulated tumorigenicity studies. Paper presented at the national meeting of the American Statistical Association, Las Vegas, NV.

Hurwitz, ES, MJ Barrett, D Bregman, WJ Gunn, LB Schonberger, WR Fairweather, et al (1985). Public Health Service study of Reye's syndrome and medications--Report of the pilot phase. New Eng J Med, 313, No.14, 849-857

Fairweather, WR (l984). FDA perspectives in process validation. Invited paper presented at the national meeting of the American Statistical Association, Philadelphia PA.

Krushat, WM, SA Edlavitch, GV Quinnan, Jr., E Barker, WR Fairweather, T Hayes, F Rosa, and DB Burlington (l983). Conditional logistic analysis of the reported association between salicylates and Reye Syndrome. Paper presented (by WM Krushat) to Society for Epidemiological Research, Winnipeg, Canada.

Fairweather, WR (l982). Quality control and statistics at FDA. Paper presented at meeting of the Quality Control Section of Pharmaceutical Manufacturers Association, Arlington, VA

__________ (1982). A model of antibiotic prescribing practices of US physicians: Treatment of URT infections. Paper presented at meeting of the Israel Statistical Association, Jerusalem, Israel.

__________ (l982). Statistical aspects of in-vivo/in-vitro correlation. Invited paper presented at 15th Annual Industrial Pharmacy Management Conference, Madison WI.

__________ (l98l). Distribution-free comparison of multiple tumor incidence in the presence of unrelated censoring. Amer. J. Math. Management Sci.,l, 267-288.

Anello, C and WR Fairweather (l98l). Statistical principles in the regulatory process. Pharm. Tech., November, 90-97.

Shosteck, H and WR Fairweather. (l979). A comparative analysis of physician response rates to mail and personal interview surveys. Public Opinion Quarterly 43, 206-2l7.

Fairweather, WR (l978). Some exact, one-sided contingency table tests. Paper presented at the national meeting of the American Statistical Association, San Diego, CA.

__________ (l977). Investigating relationships between in vivo and in vitro variables for the purpose of prediction. J. Pharmacok. Biopharm. 5, 405-4l8.

__________ (l976). Bioequivalence studies as examples of the use of crossover designs. Paper presented to the Biometric and Epidemiological Methodology Advisory Committee, Food and Drug Administration.

__________ (l976). Multiple comparisons and multiple testing for combination drugs. Paper presented to the Biometric and Epidemiological Methodology Advisory Committee, FDA.

__________ (l976). Growth curves and bioequivalence--an empirical investigation. Paper presented at the Ninth International Biometric Conference, Boston, MA.

__________ (l974). Comments on papers by Metzler and Lyon. Paper presented at the Gordon Research Conference, NH.

__________ (1973). A test for multivariate normality based on a characterization. Dissertation submitted in partial fulfillment of the requirements for the Doctor of Philosophy, University of Washington, Seattle WA.

__________ (l972). A method of obtaining an exact confidence interval for the common mean of several normal populations. Appl. Statist. 2l, 229-233.

__________ (l972). A test for multivariate normality based on a characterization (preliminary report). Bull. Instit. Math. Statist. l, l37.

Lee, HG, AW Cheever and WR Fairweather (l97l). Influence of parasite strain on chemotherapy of murine infections with Schistosoma mansoni. Bull. Wld. Hlth. Org. 45, l47-l55.

Fairweather, WR (l968). Some extensions of Somerville's procedure for ranking means of normal populations. Biometrika 55, 4ll-418.

 

 

 

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