TY - JOUR
T1 - Bioavailability and genetic prescribing
AU - Mindel, Joel S.
N1 - Funding Information:
78. Smith TW, Butler VP, Haber E: Determina-resultedin this article. tion of therapeuticand toxic serum digoxin Supported in part by National Eye Institute concentrationsby radioimmunoassayN. Engl grant EY-00340.The authoris a ResearchCareer J Med 281:1212-12161, 969 Developmenat wardee.
PY - 1976
Y1 - 1976
N2 - Although oral drug bioinequivalence has been attributed to a number of causes (excipients, dosage form, variation in dissolution time, and aging) less is known about bioavailability problems of topical medications in ophthalmology. Factors that can alter drug absorption from solutions (pH, partition coefficient, container impurities, contact time, etc.) are noted, and cases in which bioavailability problems should be considered as causes of therapeutic failure are discussed. Various attitudes representing pharmaceutical companies, the federal government, pharmacists, consumers and physicians toward the related problems of bioinequivalence and generic prescribing are examined. Techniques for in vivo and in vitro drug testing and for establishing uniform conditions of drug manufacture and storage can contribute to identification and minimization of bioavailability problems. A rational program based on a combination of such techniques could, ultimately, lead to establishment of the terms "generic equivalency" and "therapeutic equivalency" as synonymous.
AB - Although oral drug bioinequivalence has been attributed to a number of causes (excipients, dosage form, variation in dissolution time, and aging) less is known about bioavailability problems of topical medications in ophthalmology. Factors that can alter drug absorption from solutions (pH, partition coefficient, container impurities, contact time, etc.) are noted, and cases in which bioavailability problems should be considered as causes of therapeutic failure are discussed. Various attitudes representing pharmaceutical companies, the federal government, pharmacists, consumers and physicians toward the related problems of bioinequivalence and generic prescribing are examined. Techniques for in vivo and in vitro drug testing and for establishing uniform conditions of drug manufacture and storage can contribute to identification and minimization of bioavailability problems. A rational program based on a combination of such techniques could, ultimately, lead to establishment of the terms "generic equivalency" and "therapeutic equivalency" as synonymous.
KW - bioavailability
KW - bioinequivalence
KW - drug control
KW - drugs
KW - generic prescribing
UR - http://www.scopus.com/inward/record.url?scp=0017194549&partnerID=8YFLogxK
U2 - 10.1016/0039-6257(76)90124-7
DO - 10.1016/0039-6257(76)90124-7
M3 - Review article
C2 - 13505
AN - SCOPUS:0017194549
SN - 0039-6257
VL - 21
SP - 262
EP - 275
JO - Survey of Ophthalmology
JF - Survey of Ophthalmology
IS - 3
ER -