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.
