Generic Equivalence and Inequivalence of Oral Products

Melnick D. Hochberg M. Oser B. L. : Physiological Availability of the Vitamins, J. Nutrition 30: 67–69, 1945.

Oser B. L. Melnick D. Hochberg M. : Physiological Availability of the Vitamins. Study of Methods for Determining Availability in Pharmaceutical Products, Ind. Eng. Chem. Anal. Educ. 17: 401–411, 1945.

Chapman D. G. Crisafio R. Campbell J. A. : The Relationship Between in Vitro Disintegration Time of Sugar Coated Tablets and Physiological Availability of Riboflavin, J. Am. Pharm. Assoc. Sci. Ed. 43: 297–304, 1954.

Chapman D. G. Crisafio R. Campbell J. A. : The Relationship Between in Vitro Disintegration Time of Sugar-Coated Tablets and Physiological Availability of Sodium p-Aminosalicylate, J. Am. Pharm. Assoc. Sci. Ed. 45: 374–378, 1956.

Anon.: 24 Reasons Why Rx Brand Names Are Important to You, National Pharmaceutical Council, Inc., 610 Fifth Avenue, Rockefeller Center, New York, N. Y., 1957.

Anon.: The Importance of Pharmaceutical Know-How, National Pharmaceutical Council, Inc. (address above), year of publication not recorded.

Anon.: Misconceptions About So-Called “Generic Equivalent” Drugs, National Pharmaceutical Council, Inc. (address above), year of publication not recorded.

Schlager J. McGinn J. T. Hennessy D. : Comparative Theophylline Blood Levels Following Oral Administration of Three Different Theophylline Preparations, Am. J. Med. Sci. 233: 296–302, 1957.

Juncher H. Raaschou F. : The Solubility of Oral Preparations of Penicillin V, Antibiot. Med. Clin. Therapy 4: 497–507, 1957.

Morrison A. B. Chapman D. G. Campbell J. A. : Further Studies on the Relation Between in Vitro Disintegration Time and the Urinary Excretion Rates of Riboflavin, J. Am. Pharm. Assoc. 48: 634–637, 1959.

Shenoy K. G. Chapman D. G. Campbell J. A. : Sustained Release in Pelleted Preparations as Judged by Urinary Excretion and in Vitro Methods, Drug Std. 27: 77–84, 1959.

Morrison A. B. Campbell J. A. : The Relationship Between Physiological Availability of Salicylates and Riboflavin and in Vitro Disintegration Time of Enteric Coated Tablets, J. Am. Pharm. Assoc. Sci. Ed. 49: 473–478, 1960.

Losinski E. : Physiological Availability of Dicoumarol, Can. Med. Assoc. J. 83: 177–178, 1960.

Levy G. : Comparison of Dissolution and Absorption Rates of Different Commercial Aspirin Tablets, J. Pharm. Sci. 50: 388–392, 1961.

Catz B. Ginsburg E. Salenger S. : Clinically Inactive Thyroid U.S.P.: A Preliminary Report, New Engl. J. Med. 266: 136–137, 1962.

Nelson E. Knoechel E. L. Hamlin W. E. Wagner J. G. : Influence of the Absorption Rate of Tolbutamide on the Rate of Decline of Blood Sugar Levels in Normal Humans, J. Pharm. Sci. 51: 509–514, 1962.

Schroeter L. C. Tingstad J. E. Knoechel E. L. Wagner J. G. : The Specificity of the Relationship Between Rate of Dissolution and Disintegration Time of Compressed Tablets, J. Pharm. Sci. 51: 865–874, 1962.

Atkinson R. M. Bedford C. Child K. J. Tomich E. G. : The Effect of Griseofulvin Particle Size on Blood Levels in Man, Antibiot. Clin. Therap. 12: 232–238, 1962.

Atkinson R. M. Bedford C. Child K. J. Tomich E. G. : Effect of Particle Size on Blood Griseofulvin Levels in Man, Nature 193: 588–589, 1962.

Marvel J. R. Schlichting D. A. Denton C. Levy E. J. Cahn M. M. : The Effect of a Surfactant and of Particle Size on Griseofulvin Plasma Levels, J. Invest. Dermatol. 37: 197–203, 1963.

Carter A. K. : Substitution for Brand-Name Drugs, Can. Med. Assoc. J. 88: 98, 1963.

Carminetsky S. : Substitution for Brand-Name Drugs, Can. Med. Assoc. J. 88: 950, 1963.

Campagna F. Cureton G. Mirigian R. Nelson E. : Inactive Prednisone Tablets U.S.P. XVI, J. Pharm. Sci. 52: 605–606, 1963.

Levy G. Hall N. A. Nelson E. : Studies on Inactive Prednisone Tablets U.S.P. XVI, Am. J. Hosp. Pharm. 21: 402 only, 1964.

Corbus H. F. : Enteric Coated Thyroid as a Cause of Relapse in Myxedema, Calif. Med. 100: 364–365, 1964.

Braverman L. E. Ingbar S. H. : Anomalous Effects of Certain Preparations of Desiccated Thyroid on Serum Protein-Bound Iodine, New Engl. J. Med. 270: 439–442, 1964.

Brudney N. Stewart D. J. Eustice B. T. : Rate of Dissolution of Tolbutamide Tablets, Can. Med. Assoc. J. 90: 980–981, 1964.

Nelson E. Long S. Wagner J. G. : Correlation of Amount of Metabolite Excreted and Its Excretion Rate with Available Surface Area of Tolbutamide in Dosage Form, J. Pharm. Sci. 53: 1224–1227, 1964.

Middleton E. J. Davies J. M. Morrison A. B. : Relationship Between Rate of Dissolution, Disintegration Time, and Physiological Availability of Riboflavin in Sugar-Coated Tablets, J. Pharm. Sci. 53: 1378–1380, 1964.

Levy G. Hollister L. E. : Failure of the U.S.P. Disintegration Test to Assess Physiological Availability of Enteric Coated Tablets, N. Y. J. Med. 64: 3002–3005, 1964.

Leonards J. L. Levy G. : Absorption and Metabolism of Aspirin Administered in Enteric Coated Tablets, J. Am. Med. Assoc. 193: 99–104, 1965.

Clark R. L. Lasagna L. : How Reliable are Enteric Coated Aspirin Preparations?, Clin. Pharmacol. Therap. 6: 568–574, 1965.

Lu F. C. Rice W. B. Mainville C. W. : A Comparative Study of Some Brands of Tolbutamide in Canada Part II. Pharmaceutical Aspects, Can. Med. Assoc. J. 92: 1166–1169, 1965.

Morrison A. B. Campbell J. A. : Tablet Disintegration and Physiological Availability of Drugs, J. Pharm. Sci. 54: 1–8, 1965.

Slesser A. E. : The Myth of Drug Product “Equivalency,” reprint of an address given on June 1, 1965, at a meeting of the Hillsboro County Medical Association in Tampa, Florida.

Spivak J. : Drug-Buying Policies in Medicare Draw Fire; Costs, Quality at Issue, Wall Street J. October 26, 1966, pp. 1.

Faculty of the Department of Pharmacy, School of Pharmacy, University of California: Generic Equivalence and Therapeutic Efficacy, presented by Dr. Jere E. Goyan of the Subcommittee on Health, Education, and Welfare Services to the Assembly Interim Committee on Ways and Means Hearing on Drug Prices, November 22, 1966, Sacramento, California.

Young B. A. Kellock T. D. : Risk of Changing from Ox to Pig Insulin, Lancet 2: 910–911, 1966.

Wagner J. G. : Design and Data Analysis of Biopharmaceutical Studies in Man, Can. J. Pharm. Sci. 1: 55–68, 1966.

Levy G. : Case History of a Pharmaceutical Formulation Failure, Clin. Pharmacol. Therap. 8: 887–889, 1967.

Knoechel E. L. Sperry C. C. Lintner C. J. : Instrumented Rotary Tablet Machines II Evaluation and Typical Applications in Pharmaceutical Research, Development and Production Studies, J. Pharm. Sci. 56: 116–130, 1967.

Cooper J. D. : Military's Experience Shows Generic-Equivalency Failures, Med. News, April 17, 1967.

Anon: Public Health Service Backing Two “Drug Equivalencey” Tests, Drug Trade News, May 8, 1967, pp. 1.

Carey F. : Military to Stiffen Drug-Buying Rules, Kalamazoo Gazette, May 13, 1967, pp. 8.

Cooper J. D. : Hospital Prescribing Trend Spurs Use of Generic Names, Med. News, May 15, 1967, pp. 16.

Hall D. G. : The “Generic” Drug Controversy, Congressional Record-House May 17, 1967, pp. H5682–H5685.

Pfeiffer C. C. Goldstein L. Murphee B. B. Hopkins M. : Bioassay of Different Formulations of Aspirin by Means of Human EEG, J. Pharm. Sci. 56: 1338–1340, 1967.

Searl R. D. Pernarowski M. : The Biopharmaceutical Properties of Solid Oral Dosage Forms, Can. Med. Assoc. J. 96: 1513–1520, 1967.

Feldmann E. G. : Statement of the National Formulary of the American Pharmaceutical Association to the Select Committee on Small Business—Subcommittee on Monopoly of the Senate of the United States, 90th Congress, 1st Session, June 8, 1967.

Anon.: Agenda of the Task Force on Prescription Drugs. Meeting on Therapeutic Equivalence, July 20, 1967.

Anon.: Britain Is Urged to Ban Drug Brand Names, Make Firms Negotiate Prices with Agency, Wall Street J. September 29, 1967.

Rowe T. D. : The Role of Pharmacy in the Next Century, Univ. Michigan Med. Center J. 33: 165–166, 1967.

Apple W. S. : Pharmacist's Position at Stake, A.Ph.A. Newsletter 6: 1, 6, 1967.

Anon.: Gilman Views Draw Fire at Nelson Drug Hearing, Hosp. Tribune 1: 1–22, 1967.

Anon.: Therapeutic Equivalence Question Unsettled, Chem. Eng. News, December 11, 1967, pp. 38–40.

Anon.: Generic Chloramphenicol Must Match Chloromycetin, Chem. Eng. News, January 1, 1968, pp. 11.

Anon.: GAO Likes Generic Approach, Chem. Eng. News, January 29, 1968, pp. 76–77.

Anon.: Goddard sees '68 Action on Generics and Labeling, Hosp. Tribune 2: 1, 4, 1968.

Hodges R. M. : Biopharmaceutic Equivalency and the Role of the Food and Drug Administration, Am. J. Hosp. Pharm. 25: 121–127, 1968.

Feldmann E. G. : Biopharmaceutics and Drug Standards, Am. J. Hosp. Pharm. 25: 111–119, 1968.

Martin C. M. Rubin M. O'Malley W. E. Garagusi V. F. McCauley C. E. : Comparative Physiological Availability of “Brand” and “Generic” Drugs in Man: Chloramphenicol, Sulfisoxazole and Diphenylhydantoin, Pharmacologist 10: 167, 1968.

Middleton E. J. Chang H. S. Cook D. : The Physiological Availability and in Vitro Dissolution Characteristics of Some Solid Formulations of Para-Aminosalicylic Acid and Its Salts, Can. J. Pharm. Sci. 3: 97.101, 1968.

Feldmann E. G. : Pharmacy's ‘Hawks’ and ‘Doves’, J. Am. Pharm. Assoc. NS8: 393–394, 1968.

Goddard J. L. : The Equivalency Debate, J. Clin. Pharmacol. J. New Drugs 8: 205–211, 1968.

Pharmaceutical Manufacturers Association: Bibliography on Biopharmaceutics, Washington, D.C., July, 1968.

Glazko A. J. Kinkel A. W. Alegnani W. C. Holmes E. L. : An Evaluation of the Absorption Characteristics of Different Chloramphenicol Preparations in Normal Human Subjects, Clin. Pharmacol. Therap. 9: 472–483, 1968.

Anon.: Brand, Generic Drugs Differ in Man, J. Am. Med. Assoc. 205: 23, 24, 30, 1968.

Murray W. : Comparative Performance of Equivalent Drugs, presented at the 1968 Scientific Assembly of the Medical Society of the District of Columbia, Washington Hilton Hotel, November 22, 1968 and reprinted with permission of the Medicals Annals of the District of Columbia.

Varley A. B. : The Generic Inequivalence of Drugs, J. Am. Med. Assoc. 206: 1745–1748, 1968.

Anon.: Diphenylhydantoin Overdosage, Clin-Alert, December 31, 1968, No. 287.

Banes D. : Therapeutic Equivalence of Drugs—FDA Viewpoints, paper presented at the 5th National Meeting of the A.Ph.A. Academy of Pharmaceutical Sciences, Washington, D.C., November 17–20, 1968.

Feldmann E. G. : Brand Versus Generic Drugs, J. Am. Pharm. Assoc. NS9: 8–12, 1969.

Castle W. B. Astwood E. B. Finland M. Keefer C. S. . (Subcommittee of the Policy Advisory Committee, Drug Efficacy Study), “White Paper on the Therapeutic Equivalence of Chemically Equivalent Drugs,” J. Am. Med. Assoc. 208: 1171–1172, 1969.

Task Force on Prescription Drugs. Final Report, Department of Health, Education, and Welfare, 1969, pp. X.

Bartelloni P. J. Calia F. M. Minchew B. H. Beisel W. R. Ley H. L. Jr. : Absorption and Excretion of Two Chloramphenicol Products in Humans After Oral Administration, Am. J. Med. Sci. 258: 203–208, 1969.

Brice G. W. Hammer H. F. : Therapeutic Non-equivalence of Oxytetracycline Capsules, J. Am. Med. Assoc. 208: 1189–1190, 1969.

Schamberg I. L. : Therapeutic Equivalence of Prescription Drugs, J. Clin. Pharmacol. J. New Drugs 9: 205–216, 1969.

Levy G. : Comparative Performance of Equivalent Drugs—Some Questions and Answers, Med. Ann. District Columbia 38: 301–303, 1969.

Schneller G. H. : Hazard of Therapeutic Nonequivalency of Drug Products, J. Am. Pharm. Assoc. NS9: 455–459, 1969.

Barr W. H. : Factors Involved in the Assessment of Systemic or Biologic Availability of Drug Products, Drug Information Bull. 3: 27–45, 1969.

Macdonald H. Pisano F. Burger J. Dornbush A. Pelcak E. : Physiological Availability of Various Tetracyclines, Drug Information Bull. 3: 76–81, 1969.

Several authors: Symposium on Formulation Factors Affecting Therapeutic Performance of Drug Products, Drug Informotion Bull. 3: 6–119, 1969.

Gelber R. Jacobsen B. A. Levy L. : A Study of the Availability of Six Commercial Formulations of Isoniazid, Clin. Pharmacol. Therap. 10: 841–848, 1969.

Several authors: Papers from the Symposium on “The Physiological Equivalence of Drug Dosage Forms,” presented by the Food and Drug Directorate in Ottawa, Canada, on June 26 and 27, 1969, published by authority of the Hon. John Monro, Minister of National Health and Welfare, Queen's Printer for Canada, Ottawa, Canada, 1970, Cat. No. H44-2969.

Anon.: FDA Commissioner Edwards Discusses Therapeutic Equivalency, A. Ph.A. Newsletter 9: 3, 1970.

A.Ph.A. Academy of Pharmaceutical Sciences: Drug Product Quality, J. Am. Pharm. Assoc. NS10: 107–116, 1970.

Several authors: Compilation of Symposia Papers Presented at the 5th National Meeting of the A.Ph.A. Academy of Pharmaceutical Sciences, American Pharmaceutical Association, Academy of Pharmaceutical Sciences, Washington, D.C., 20037, 1970, 465 pp.

Foldes E. G. Campbell K. N. Wohlman A. : Comparative Blood Level Study of Different Brands of Chlordiazepoxide Hydrochloride and Their Coadministration with Chymotrypsin, Intern. J. Clin. Pharmacol. 3: 338–343, 1970.

Blair D. C. Barnes R. W. Wildner E. L. Murray W. J. : Biological Availability of Oxytetracyline Hydrochloride Capsules. A Comparison of all Manufacturing Sources Supplying the United States Market, J. Am. Med. Assoc. 215: 251–254, 1971.

Wagner J. G. Welling P. G. Lee K. P. Walker J. E. : Studies on the in Vivo and in Vitro Availability of Some Commercial Warfarin Tablets, J. Pharm. Sci. in press, 1971.

Welling P. G. Lee K. P. Patel J. A. Walker J. E. Wagner J. G. : Urinary Excretion of Ephedrine in Man without pH Control Following Oral Administration of Three Commercial Ephedrine Sulfate Preparations, J. Pharm. Sci. in press, 1971.