Dangers of Overcompliance: Preserving the Future of Drug Development, Grand Rounds, Leukemia Department, University of Texas MD Anderson Cancer Center, Houston, TX, 6/7/06.

Approaching Sources of Funding for Product Development First International Symposium on Translational Clinical Research for Inherited and Orphan Diseases, sponsored by the National Neurovision Research Institute, 11/04.

How To Avoid Clinical Failure in Small-Company and Biotech Drug Development First International Symposium on Translational Clinical Research for Inherited and Orphan Diseases, sponsored by the National Neurovision Research Institute, 11/04.

Regulatory Capture in Reverse: Overcompliance Is Strangling Drug Development, AAPP, 11th Annual Meeting, Atlanta, 11/04.

Molecular Diagnostics and Therapeutic Drugs: Understanding and Validating the Clinical Claims and the Evidence Needed To Support Them, Molecular Diagnostics Symposium, Center for Business Intelligence, Arlington, VA, 11/04.

Expedited Drug Approval Pathways: Do they substantially expedite drug development and approval? In: "Expedited Drug Approval Pathways: Strategic Planning, Implementing and Achieving Faster Product Approval." Barnett International Symposium, Philadelphia (Wardell: Speaker & Session Chair), 11/03.

Accelerating Clinical Drug Development: Strategically & Tactically. 
NJ Association of Pharmaceutical Licensing Executives, Basking Ridge, 11/99.

Accelerating Phase III trials. IIR Mtg. a) Strategically; b) Tactically / Operationally, IRR Workshop, Philadelphia, 11/99.

Strategic Global Drug Development: a CRO perspective. In: Key Issues In Pharmaceutical R&D Management: Managing a Global Submission & Developing an Integrated Global Strategy, Tufts CSDD Workshop, Philadelphia, 11/99.

Accelerating Clinical Development: "Standards of evidence for approval / Is there a 'Silver Standard'?" (Panel Debate with Dr Robert Temple, FDA), DIA Annual Meeting, 6/99.

Accelerating Clinical Trials, DIA Annual Meeting, 6/99.

Accelerating Clinical Trials: increasing success rates, earlier approvals, DIA Annual Meeting, 6/99.

Use of Metrics in Improving Clinical Trials, DIA Annual Meeting, 6/99.

Developing the Portfolio: clinical development and regulatory approval; and Optimizing the process: How problems in the drug development process are being addressed" Both given at: Wharton - Windhover Pharmaceutical Executive MBA course, 4/99.

The Food & Drug Modernization Act - Business Opportunities for a CRO Pharmacoeconomics of Botanicals & The Public Health (Poster), 3/99. 

The Strategic Product Development Plan: Use of the PDP in Business Development: Creating the initial SPDP for a compound in early development (Poster), 3/99.

The Strategic Product Development Plan: Use of the SPDP in Business Development: Creating the initial SPDP for a compound in early development Innovations meeting: Philadelphia, 3/99.

Rationale for facilitated early human study of drug candidates in the US. PhRMA/ FDA DRUSAFE DC, 9/96.

Therapeutics and Culture. Drug Information Association Annual Meeting, San Diego, CA, 6/92.

II. Regulation and Regulatory Reform

The "New" Drug Approval / Utilization System: Do we have it already? Will it speed Drug Development & Approval while maintaining Safety? ASCPT Annual Meeting (Wardell: Speaker and Session Chair), 3/02.

The FDA as a Consulting Firm: A comparative view across products, companies and Agencies/Continents" In Tufts CSDD workshop on "Seeking FDA Advice to Speed New Drug Development: In: The Role of FDA/Sponsor Mtgs", Philadelphia, 2/99.

Plan for Reforming Regulation of the US Drug and Device Development Process. PFF, Washington, DC, 2/96 - presentation and book.

Approval Standards for Drug Efficacy in the Future: PhRMA Clinical/Regulatory Annual Update, DC, 4/95.

What Information is Needed to Support a Dose for Registration? ICH-1 & 2. PhRMA rep. & speaker on Efficacy Expert Working Group, Dose-Response topic. Also given at DIA Annual Meeting, Arlington,VA, 7/92. 

Statement before the Committee on the Approval Process for Drugs for Cancer and AIDS ("Lasagna Committee"), 4/90 (Representing ASCPT).

III. Specialized Drug Development Areas (Biotechnology and Small Companies, PharmacoGenomics, Botanicals)

IIIA. Biotechnology and Small Companies

Australasian Small Companies in the US Environment: Planning the Most Efficient Drug Development Program, for the BioRelationships 2006 Conference of the American Australian Association, Boston, MA, 4/5/06.

The Small-Company Model in Early-Phase Drug Development: What Small Companies Must Do To Survive, for the Association of Clinical Pharmacology Units, Bethesda, MD, 10/18/05.

Decisions Emerging Companies Must Make: What We Can Learn About Success and Failure Factors from Small-Company Development Experience, & Writing Product Development Plans, Seminar for Drexel University Executive MBA program in Drug Development, Philadelphia, October 2004 and 2005.

Avoiding Drug-Development Failures in Biotech and Emerging Companies , Harvard Business School Club: Seminar, NYC Chapter, 11/02.

Setting the Strategic Path: Decisions Emerging Companies Must Make. In: session on "Strategy & Outsourcing for Small Companies," DIA Annual Meeting, 6/02.

Optimizing Success, Failure & Attrition in Drug Development: What have we learned from the Biotech experience to date?"
Hoffman La Roche, Nutley NJ; Clinical Pharmacology Drug Development Seminar Series; Professor Pieter Joubert, Head of Clinical Pharmacology, 1/99.

Predicting Success Rates in Biotechnology Drug Development: ASCPT 
Annual Meeting, Orlando, 3/96.

Contribution of Biotechnology to the Pharmaceutical Pipeline: Biotechnology Drugs Meet Regulatory Reality - What Happened? Why? American College of Clinical Pharmacology annual meeting, Boston, 10/94.

Clinical Drug Development in Biotechnology: Reconciling Scientific Realities with Investor Needs IBC, Philadelphia, 9/94.

Clinical Drug Development in Biotech Companies vs Pharmaceutical Companies: IRB perspective. PRM&R/Tufts, Boston, 10/93.

IIIB. PharmacoGenomics

Personalized Medicine: Where Are the Real Opportunities? TiECON East 2007 (The Indus Entrepreneurs’ East Coast Annual Conference), Moderator, Hynes Convention Center, Boston, 6/15/07.

The Zen of Theranostics: Can Pharmacogenetics Deliver the Goods? Medical History Society of NJ, Princeton, NJ, 5/23/07.

Genomics: Can Pharmacogenomics Deliver on Its Extravagant Claims? Understanding the Realities of Therapeutics, for SCBA/BioPharm 2005 Annual conference: “Tackling the Challenges in Drug Research, Development and Commercialization”, Rutgers University, Piscataway, NJ, 12/4/05.Rutgers University, Piscataway, NJ, 12/4/05

Implementing the Claims of PharmacoGenomics in the Real World of Graded Dose/Exposure-Response Relationships. In: "Optimizing Dose & Exposure Response Studies," Barnett International, Philadelphia, 4/04.

'Personalized Medicines' and 'Individualized Therapeutics': Scrutinizing the Extraordinary Claims of PharmacoGenomics. Medical Rounds, Hackensack Hospital, 3/04.

Validating and Implementing PharmacoGenomic Hypotheses: How shall we recognize, prove, and develop a feasible clinical claim? Session on: Commercializing PharmacoGenomics, DIA Annual Meeting, 6/03.

PharmacoGenomics in Clinical Development, Therapeutics, and the Market: Key Issues, with Reference to Pulmonary Examples. In: "Drug Development in Pulmonary Diseases, PERI, Baltimore, 6/02.

Converting PharmacoGenomic Knowledge into Therapeutic Advances and Market Success: PharmacoGenomics in the Real World, 12/01; and 11 prior presentations in various venues, including FDA and AAPS. 
View PowerPoint Presentation

Where's the "Pharm" in PharmacoGenomics? US Food & Drug Administration, Rockville, 8/01.

What Clinical Information Is Needed To Place PharmacoGenomic Claims into a Drug Label? Conference on: SNPs for Disease Association & Drug Response: Creating Medical Value Through SNPs. Global Business Research, San Diego, 3/00.

Translating Pharmacogenomic claims into Drug labeling & Market Advantage: Clinical methodologies & Issues. (Also: Panel discussion "Impact of PharmacoGenomics - an Industry Perspective.") 
PHARMACOGENOMICS IMPACT Meeting: Center for Business Intelligence, San Francisco, 12/99.

PharmacoGenomics: "What is the unmet need for the Drug Industry?" In: Applying Genetics in Drug Development to Maximize Success & Market Potential of New Pharmaceuticals. IBC, Boston, 7/99.

IIIC. Developing Botanical Medicines to US IND/NDA Standards

Scrutinizing Herbal Medicines: What have we learned in the last millennium, century, and decade? Medical History Society of New Jersey, 5/04.

Experiences and Lessons-Learned in Developing Botanical TCM Products to FDA's IND-NDA Standards, Bio-2001: US Taiwanese Scientists Annual Meeting, Newark, 11/01.
View PowerPoint Presentation

Alternative Medicine & Herbal Remedies: Can they be developed to modern evidentiary standards? American Academy of Pharmaceutical Physicians (AAPP), Regional Meeting @ SmithKline Beecham, Philadelphia, 9/99.

Developing Herbal Medicines up to modern pharmaceutical standards of evidence. (Part of Covance Laboratories Workshop), Nutracon: Annual Meeting, Las Vegas, 7/99.

Evaluating botanicals by modern standards: Principles & lessons: in: Nutritional supplements in Managed Care. DIA, Washington, DC, 3/99.

IV. Medical Device Development and Regulation

Lessons from Drug and Device Development: What can each learn from the other? BioWest 11/95; BioEast, 1/96; IBC, 6/96.

Technology Assessment of New Devices: What evidence should be required to admit novel devices to the market? 2nd Annual Conference on Health Services Research in Radiology, U.Penn, 9/95.

Responsible Reform of US Regulation of Development & Approval ofDrugs & Devices: AEI, DC, 3/95.

V. Statements / Participation in Congressional Committees & Government Panels

What Information Is Needed to Support a Dose for Registration? Keynote speech for US PMA/FDA delegation at the Efficacy section, First International Conference on Harmonization (ICH-1); Brussels.

Role of Regulations in Drug Development and Therapeutics. Statement representing the American Society for Clinical Pharmacology and Therepeutics, (ASCPT) before HHS Review Panel on New Drug Regulation ("Lasagna Committee").

"Current Trends and State of New Drug Development in the United States" Commission on the Federal Drug Approval Process.

Member of the Pharmaceutical Panel of the Committee on Technology and International Economic and Trade Issues, National Academy of Engineering/National Academy of Sciences.

"Legislative and Regulatory Environment That Might Affect Biotechnology" Library of Congress Congressional Research Service, Science Policy Research Division, Workshop on Biotechnology for the House Committee on Science and Technology. 

"Pharmaceutical Patent Life and Innovation" Subcommittee on Investigations and Oversight of the US House Committee on Science and Technology: Hearings on the Waxman-Hatch Bill.

"FDA's New-Drug Approval Process" U.S. House of Representatives, Science, Research and Technology Subcommittee: (review of the General Accounting Office Drug Lag Study).

U.S. House of Representatives, Health Subcommittee: Statements on Sections 108e, g, h and Section 185 of the Drug Regulation Reform Act of 1978 (H.R. 11611).

U.S. House Health Subcommittee: Testimony on the Drug Regulation Reform Act of 1978 (H.R. 12980) as Chairman of the Drug Regulatory Committee of ASCPT (jointly with Dr. Arthur Hayes).

Food and Drug Administration: Testimony as Chairman of the Drug Regulatory Committee (ASCPT) on the Drug Regulation Reform Act of 1978 (S.2755).

"Regulation and Pharmaceutical Innovation: A Review of the Relationship Between Government [Safety] Regulation and Innovation Leading to Medically Useful Drugs" Subcommittee on Regulation, Advisory Group on Contributions of Technology to Economic Strength (National Science Foundation).

Member, Scholarly Adjunct to the Special Study Panel, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Consultant, Federal Trade Commission.

"Role of Regulations in Drug Development & Therapeutics" HEW Review Panel on New Drug Regulations.

BOOKS:

Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century (Monograph): Epstein R, Lenard T, Miller H, Tollison R, Viscusi K, & Wardell, W; PFF, Washington, DC, 1996.

Drug Development, Regulatory Assessment, and Postmarketing Surveillance. Wardell, W.M., Velo, G.P. (editors): New York, New York: Plenum Publishing Company, 1982.

Controlling the Use of Therapeutic Drugs: An International Comparison. Wardell, W.M. (ed.). Washington, D.C.: The American Enterprise Institute for Public Policy Research, 1978. (Also published in Japanese in Japan.)

Regulation and Drug Development. Wardell, W.M., Lasagna, L. Washington, D.C.: The American Enterprise Institute for Public Policy Research, 1975.

PAPERS & BOOK CHAPTERS (Selected):

Wardell William, Vodra William, Jones Judith K, and Spivey Richard, Evolution and Future Prospects of Pharmaceutical Industry Regulation. Chapter 12 in: Handbook of Pharmaceutical Public Policy, Thomas R. Fulda and Albert I. Wertheimer (Editors). Pharmaceutical Products Press, Binghamton, NY, 2007.

Wardell William, Baumbauer Eberhard, [Review of] Arthur A. Daemmrich, Pharmacopolitics: Drug Regulation in the United States and Germany. In The International History Review, XXVIII, 2, June 2006.

Spivey Richard N, Jones Judith K, Wardell William, Vodra William. The US FDA in the Drug Development, Evaluation and Approval Process. Chapter 21 in: The Textbook of Pharmaceutical Medicine 5th Edition, Griffin John P, O'Grady John (Editors), BMJ Books, London, 2006.

Wardell William, Vodra William, Jones Judith K, Spivey Richard N. Past Evolution and Future Prospects of the Pharmaceutical Industry and Its Regulation in the USA. Chapter 22 in: The Textbook of Pharmaceutical Medicine 5th Edition, Griffin John P, O'Grady John (Editors), BMJ Books, London, 2006.

Wardell, William, Approaching Sources of Funding for Product Development, & How To Avoid Clinical Failure in Small Company and Biotech Drug Development, First International Symposium on Translational Clinical Research for Inherited and Orphan Diseases, sponsored by the National Neurovision Research Institute, Supplement to RETINA, 2005

Wardell W, Toland Susan, and Fox Anthony W. What Pharmaceutical Medicine Is and Who Does It. In: Principles and Practice of Pharmaceutical Medicine, Fletcher Andrew J, Edwards Lionel D, Fox Anthony W, Stonier Peter (Editors), John Wiley & Sons, Ltd, West Sussex and NY, 2002.

Spivey Richard N, Lasagna Louis, Jones Judith K, Wardell William. The US FDA in the Drug Development, Evaluation and Approval Process. In: The Textbook of Pharmaceutical Medicine 4th Edition, Griffin John P, O'Grady John (Editors), BMJ Books, London, 2002.

Wardell WM, Given K & Wilson, R. Drug Regulation in the U.S.A. in: The Textbook of Pharmaceutical Medicine 3rd edition. Griffin JP, O'Grady J, & D'Arcy, PF.(Editors) Queens University, Belfast, 1998.

New Drug Development Can Get Boost From Managed Care. Wardell,WM. Drug Benefit Trends 10 40-42(1998).

The Changing Environment within Contract Research Organizations. Clinical Research & Regulatory Affairs 14 265-274, 1997.

Cost of Discovering, Developing, Manufacturing and Marketing Biotechnological Products. In: The Clinical Pharmacology of Biotechnological Products; Amsterdam: Elsevier Science Publishers B.V.; 1992.

What Information is Needed to Support a Dose for Registration? Proceedings of the First International Conference on Harmonization (ICH-1); Brussels: 1992. pp. 478-491.

Multicenter Diltiazem Propranolol Infarction Trial (MDPIT). New England Journal of Medicine, 1988. (Wardell Chairman of the Data Monitoring & Safety Board).

Cox, C., Davis, H.T., Wardell, W.M., Calimlim, J.F. and Lasagna, L.: Graphical analysis of multivariate pain data in analgesic trials. Controlled Clinical Trials 7:53-64, 1986.

Mattison, N., Thomas E., Trimble, A.G., Wardell, W.M. The development of self-originated new drugs by Swiss pharmaceutical firms, 1960-1980. European Journal of Clinical Pharmacology. 

Wardell, W.M., Sheck, L. Is pharmaceutical innovation declining? Interpreting measures of pharmaceutical innovation and regulatory impact in the USA, 1950-1980. Proceedings of the Arne Ryde Symposium on Pharmaceutical Economics, 27-28 September 1982, Helsingborg, Sweden.

Wardell, W.M., May, M.S., Trimble, A.G. New drug development by United States pharmaceutical firms, with analyses of trends in the acquisition and orign of drug candidates, 1963-1979. Clinical Pharmacology and Therapeutics 32(4):407-417, 1982.

Calimlim, J.F., Wardell, W.M., Sriwatanakul, K., Lasagna, L., Cox, C. Analgesic efficacy of parenteral metkephamid acetate in the treatment of post-operative pain. The Lancet i:1374-1375, 1982.

Wardell, W.M., Mattison, N. The assessment of medical technologies using risk-benefit, cost-benefit and cost-effectiveness analysis. In: Proceedings of World Medical Association (WMA) Follow-Up Committee on Development and Allocation of Medical Care Resources. Tokyo, Japan: Japan World Medical Association, 1982, pp. 84-98.

Wardell, W.M. Can improved postmarketing surveillance (Phase IV) permit earlier drug approval? Chapter 6 in: Society and Medication: Conflicting Signals for Prescribers and Patients (J.P. Morgan and D.V. Kagan, eds.). Lexington, Massachusetts: Lexington Books, D.C. Heath & Company, 1983, pp.73-81.

Wardell, W.M. [sections in The Merck Manual]:
(a) Preclinical and clinical evaluation of toxicity. 
(b) Adverse drug reactions. 
(c) Carcinogenesis. 
(d) Benefit-to-risk ratio. 
In: The Merck Manual of Diagnosis and Therapy (14th Edition) (R. Berkow, ed.). Rahway, New Jersey: Merck Sharp & Dohme Research Laboratories, 1982, pp. 2292-2293.

Wardell, W.M. Drug testing in humans. Chapter 7 in: Modern Pharmacology (C.R. Craig and R.E. Stitzel, eds.). New York, New York: Little, Brown and Company, 1981, pp. 75-80.

Eisman, M.M., Wardell, W.M. The decline in effective patent life of new drugs. Research Management XXIV(1):18-21, 1981.

PARIS (Persantine-Aspirin Reinfarction Study) Research Group: Persantine and aspirin in coronary heart disease. Circulation 62(3):449-461, 1980.

PARIS Research Group: Persantine-Aspirin Reinfarction Study (PARIS): Design, methods and baseline results. (W.M. Wardell is member of the Data Monitoring Committee.) American Heart Association Monograph 71. Circulation 62(3):1-42 1980.

DiRaddo, J., Wardell, W.M. Research activity on systemic contraceptive drugs by the U.S. pharmaceutical industry. Contraception 23(4):345-366, 1981.

Wardell, W.M., DiRaddo, J., Trimble, A.G. Development of new drugs originated and acquired by United States-owned pharmaceutical firms, 1963-1976. Clinical Pharmacology and Therapeutics 28(2):270-278, 1980.

Ricardo-Campbell, R., Eisman, M.M., Wardell, W.M., Crossley, R. Preliminary methodology for controlled cost-benefit study of drug impact: The effect of cimetidine on days-of-work lost in a short term trial in duodenal ulcer. Journal of Clinical Gastroenterology 2:37-41, 1980.

Wardell, W.M. Methotrexate, azaribine and PUVA in the treatment of severe refractory psoriasis: A case study of the regulation of therapies that are effective but toxic. Chapter in: Current Concepts in Cutaneous Toxicity (V.A. Drill and P. Lazar, eds.). New York, New York: Academic Press, 1980, pp. 271-288.

Wardell, W.M. Scientific criteria and methods of drug assessment: Postmarketing surveillance. Chapter in: Drug Assessment: Criteria and Methods (J.Z. Bowers and G. Velo, eds.). Amsterdam, Holland: Elsevier/North Holland Biomedical Press, 1979, pp. 229-234.

Wardell, W.M. Scientific criteria and methods of drug assessment: Requirements in the United States of America. Chapter in: Drug Assessment: Criteria and Methods (J.Z. Bowers and G. Velo, eds.). Amsterdam, Holland: Elsevier/North Holland Biomedical Press, 1979, pp. 91-100.

Wardell, W.M., DiRaddo, J., Weintraub, M. The measurement of therapeutic value. Journal of Clinical Pharmacology 20(2&3):77-90, 1980.

Wardell, W.M., DiRaddo, J. The measurement of pharmaceutical innovation. Journal of Clinical Pharmacology 20(1):1-9, 1980.

DiRaddo, J., Wardell, W.M. Innovation and availability in the United States of drugs for tropical diseases. Conference: Pharmaceuticals for Developing Countries. Division of International Health, Institute of Medicine/National Academy of Sciences, Washington, D.C., January 1979. Publication Proceedings IOM-79-001:260-279, 1979.

Sundaresan, P., Wardell, W.M., Weintraub, M., Lasagna, L. Methodology for demonstrating sustained efficacy of hypnotics: A comparative study of triazolam and flurazepam. Clinical Pharmacology and Therapeutics 25(4):391-398, 1979.

Wardell, W.M., Tsianco, M.C., Anavekar, S.N., Davis, H.T. Postmarketing surveillance of new drugs. II. Case Studies. Journal of Clinical Pharmacology 19(4):169-184, 1979.

Wardell, W.M. The drug lag revisited: Comparison by therapeutic area of patterns of drugs marketed in the United States and Great Britain from 1972 through 1976. Clinical Pharmacology and Therapeutics 24(5):499-527, 1978. (6):161-168, 1979.

Wardell, W.M. Innovation in antiepileptic drug therapy. In: Workshop on Antiepileptic Drug Development. National Institute of Neurological and Communicative Disorders. DHEW (NIH)78-186. Monograph 21, Appendix VI:29-41, 1979.

Anavekar, S.N., Saunders, R.H., Wardell, W.M., Shoulson I., Emmings, F.G., Cook, C.E., Gringeri, A.J. Parotid versus whole saliva in the prediction of serum total and free phenytoin concentrations. Clinical Pharmacology and Therapeutics 24(6):629-637, 1978.

Wardell, W.M., Hassar, M., Anavekar, S.N., Lasagna, L.: The rate of development of new drugs in the United States, 1963-1975. Clinical Pharmacology and Therapeutics 24(2):133-145, 1978. Reprinted as Die Entwicklungsrate neuer Arzneimittel in den USA zwischen 1963 und 1975. Pharm. Ind. 42(8):786-794, 1980.

Karch, F.E., Wardell, W.M. Effect of halofenate on the serum binding of phenytoin. British Journal of Clinical Pharmacology 4:625-626, 1977.

Petursson, S.R., Wardell, W.M. Curran, J.P. National rates and patterns of consumption of antihypertensive drugs in relation to their availability in the United States, the United Kingdom, Australia and New Zealand. In Mild Hypertension: To Treat or Not to Treat (H. Mitchell Perry Jr. and W. McFate Smith, eds.). New York, New York: Annals of the New York Academy of Sciences (1-485) 304:320-330, 1978.

Wardell, W.M. Postmarketing surveillance, drug monitoring and adverse drug reactions: A case-study approach to the analysis of problems and possible solutions. In Drug Monitoring (F.H. Gross and W.M.W. Inman, eds.). Academic Press, 1977, pp. 241-254.

Calimlim, J.F., Wardell, W.M., Davis, H.T., Lasagna, L., Gillies, A.J. Analgesic efficacy of an orally administered combination of pentazocine and aspirin: With observations on the use and statistical efficiency of GLOBAL subjective efficacy ratings. Clinical Pharmacology and Therapeutics 21(1):34-43, 1977.

Blackwell, B., Stolley, P.D., Buncher, R., Klimt, C.R., Temple, R., Venn, D., Wardell, W.M. Clinical trial of drugs: Phase IV investigations. Clinical Pharmacology and Therapeutics 18:653-656, 1975.

Wardell, W.M. Consultative services in clinical pharmacology. Journal of Clinical Pharmacology 15:721-724, 1975.

Wardell, W.M. Preclinical and clinical evaluation of toxicity. Chapter 7 in The Merck Manual of Diagnosis and Therapy (13th edition). Rahway, New Jersey: Merck Sharp & Dohme Research Laboratories, 1977, pp. 1811-1812.

Wardell, W.M. A clinical approach to drug interactions. Chapter 6 in The Merck Manual of Diagnosis and Therapy (13th edition). Rahway, New Jersey: Merck Sharp & Dohme Research Laboratories, 1977, pp. 1804-1809.

Wardell, W.M. The assessment of the benefits, risks and costs of medical progress. Proceedings of a symposium held in London, March 1974. Chapter in Benefits and Risks in Medical Care (David Taylor, ed.). London: Office of Health Economics, 1974, pp. 93-104.

Wardell, W.M. Drug development, regulation and the practice of medicine. Journal of the American Medical Association 229:1457-1461, 1974.

Calimlim, J.F., Wardell, W.M., Lasagna, L., Gillies, A.J., Davis, H.T. Effect of naloxone on the analgesic activity of methadone in a 1:10 combination administered orally: The time and cost of flirting with the null hypothesis in tests of equivalence. Clinical Pharmacology and Therapeutics 15:556-564, 1974.

Wardell, W.M. Clinical pharmacology at university medical centers: I. Functions and organization. Journal of Clinical Pharmacology 14:309-324, 1974.

Wardell, W.M. Redistributional drug interactions: A critical examination of putative clinical examples. Chapter in Drug Interactions (P.L. Morselli, S. Garattini, S.N. Cohen, eds). New York, New York: Raven Press, 1974, pp. 123-124.

Morgan, J.P., Wardell, W.M., Lasagna, L., Mazzullo, J., Weintraub, M., Mudholkar, G., Mietlowski, W. Mebutamate as a hypnotic: Clinical trial and statistical considerations. Clinical Pharmacology and Therapeutics 14:1001-1012, 1973.

Wardell, W.M. Therapeutic implications of the drug lag. Clinical Pharmacology and Therapeutics 15:73-96, 1974.

Wardell, W.M. Introduction of new therapeutic drugs in the United States and Great Britain: An international comparison. Clinical Pharmacology and Therapeutics 14:773-790, 1973.

Stetson, J.B., Robinson, K., Wardell, W.M., Lasagna, L. Analgesic activity of oral naproxen in patients with postoperative pain. Scandinavian Journal of Rheumatology Suppl. 2:50-55, 1973.

McQueen, E.G., Wardell, W.M. Drug displacement from protein binding: Isolation of a redistributional drug interaction in vivo. British Journal of Pharmacology 43:312-324, 1971.

Wardell, W.M., Yule, A.G., Ballard, L., Forsyth, A.J. Modification of the pH method to enable rapid microbiological assay of a wide range of antibiotics. Medical Journal of Australia 1:383-386, 1971.

Prout, B.J., Wardell, W.M. Sweating and peripheral blood flow in patients with phaeochromocytoma. Clinical Science 36:109-117, 1969.