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Bioinequivalence and drug toxicity. How great is the problem and what can be done?

作者信息

Gleiter C H, Gundert-Remy U

机构信息

Abteilung Klinische Pharmakologie, Zentrum für Pharmakologie und Toxikologie der Universität, Göttingen, Germany.

出版信息

Drug Saf. 1994 Jul;11(1):1-6. doi: 10.2165/00002018-199411010-00001.

DOI:10.2165/00002018-199411010-00001

PMID:7917077

Abstract

摘要

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Bioinequivalence and drug toxicity. How great is the problem and what can be done?

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[Original brands and generic preparations].

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本文引用的文献

Clinical and statistical issues in therapeutic equivalence trials.

Eur J Clin Pharmacol. 1993;45(1):1-7. doi: 10.1007/BF00315342.

A decomposition product of a contaminant implicated in L-tryptophan eosinophilia myalgia syndrome affects spinal cord neuronal cell death and survival through stereospecific, maturation and partly interleukin-1-dependent mechanisms.

J Pharmacol Exp Ther. 1993 Aug;266(2):1029-35.

On population and individual bioequivalence.

Stat Med. 1993 Jun 30;12(12):1109-24. doi: 10.1002/sim.4780121202.

Standards for bioequivalence of inhaled products.

Clin Pharmacokinet. 1994 Jan;26(1):1-6. doi: 10.2165/00003088-199426010-00001.

Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies.

J Pharm Sci. 1993 Nov;82(11):1186-9. doi: 10.1002/jps.2600821125.

Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data.

J Pharmacokinet Biopharm. 1981 Oct;9(5):635-51. doi: 10.1007/BF01061030.

Therapeutic nonequivalence of oxytetracycline capsules.

JAMA. 1969 May 19;208(7):1189-90.

Outbreak of anticonvulsant intoxication in an Australian city.

Br Med J. 1970 Oct 31;4(5730):271-3. doi: 10.1136/bmj.4.5730.271.

Variation in biologic availability of digoxin from four preparations.

N Engl J Med. 1971 Dec 9;285(24):1344-7. doi: 10.1056/NEJM197112092852403.

Therapeutic non-equivalence of digoxin tablets in the United Kingdom: correlation with tablet dissolution rate.

Br Med J. 1973 Dec 29;4(5895):763-6. doi: 10.1136/bmj.4.5895.763.

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Bioinequivalence and drug toxicity. How great is the problem and what can be done?

作者信息

Gleiter C H, Gundert-Remy U

机构信息

Abteilung Klinische Pharmakologie, Zentrum für Pharmakologie und Toxikologie der Universität, Göttingen, Germany.

出版信息

Drug Saf. 1994 Jul;11(1):1-6. doi: 10.2165/00002018-199411010-00001.

DOI:10.2165/00002018-199411010-00001

PMID:7917077

Abstract

摘要

相似文献

Bioinequivalence and drug toxicity. How great is the problem and what can be done?

Drug Saf. 1994 Jul;11(1):1-6. doi: 10.2165/00002018-199411010-00001.

Interchangeability of Generics-Experiences and Outlook Toward Pharmacokinetics Variability and Generic-Generic Substitution.

Clin Pharmacol Ther. 2019 Feb;105(2):292-294. doi: 10.1002/cpt.1250. Epub 2018 Nov 20.

Generic equivalence and non-equivalence of drugs.

Lancet. 1972 Sep 9;2(7776):528-30. doi: 10.1016/s0140-6736(72)91919-8.

FDA moves closer to new requirements for NTI drugs.

Am J Health Syst Pharm. 2011 Sep 1;68(17):1568-9, 1570. doi: 10.2146/news110059.

[Special generic drugs in Spain].

Med Clin (Barc). 1999 Mar 13;112(9):337-9.

On Drugs: Preemption, Presumption, and Remedy.

J Leg Med. 2018 Jul-Dec;38(3-4):365-385. doi: 10.1080/01947648.2018.1473188.

Eur J Clin Invest. 2004 Dec;34(12):797-9. doi: 10.1111/j.1365-2362.2004.01428.x.

Bioequivalence and narrow therapeutic index drugs.

Pharmacotherapy. 1995 Jul-Aug;15(4):433-40.

Bioequivalence and interchangeability of narrow therapeutic range drugs. Canadian Society for Pharmaceutical Sciences discussion.

J Pharm Pharm Sci. 1998 Jan-Apr;1(1):2-7.

Bioequivalence of generic drugs.

J Clin Psychiatry. 2015 Sep;76(9):e1130-1. doi: 10.4088/JCP.15f10300.

引用本文的文献

Exploring the opinions and experiences of patients with generic substitution: a representative study of Polish society.

Int J Clin Pharm. 2015 Feb;37(1):68-75. doi: 10.1007/s11096-014-0041-8. Epub 2014 Nov 27.

Patient-reported outcomes of therapy with two brands of ibuprofen.

Pharm Pract (Granada). 2008 Jul;6(3):136-41. doi: 10.4321/s1886-36552008000300005. Epub 2008 Sep 15.

Does knowledge of medication prices predict physicians' support for cost effective prescribing policies.

Can J Clin Pharmacol. 2008 Summer;15(2):e286-94. Epub 2008 Jul 19.

[Original brands and generic preparations].

Med Klin (Munich). 2000 Jan 15;95(1):26-30. doi: 10.1007/BF03044977.

本文引用的文献

Clinical and statistical issues in therapeutic equivalence trials.

Eur J Clin Pharmacol. 1993;45(1):1-7. doi: 10.1007/BF00315342.

J Pharmacol Exp Ther. 1993 Aug;266(2):1029-35.

On population and individual bioequivalence.

Stat Med. 1993 Jun 30;12(12):1109-24. doi: 10.1002/sim.4780121202.

Standards for bioequivalence of inhaled products.

Clin Pharmacokinet. 1994 Jan;26(1):1-6. doi: 10.2165/00003088-199426010-00001.

Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies.

J Pharm Sci. 1993 Nov;82(11):1186-9. doi: 10.1002/jps.2600821125.

Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data.

J Pharmacokinet Biopharm. 1981 Oct;9(5):635-51. doi: 10.1007/BF01061030.

Therapeutic nonequivalence of oxytetracycline capsules.

JAMA. 1969 May 19;208(7):1189-90.

Outbreak of anticonvulsant intoxication in an Australian city.

Br Med J. 1970 Oct 31;4(5730):271-3. doi: 10.1136/bmj.4.5730.271.

Variation in biologic availability of digoxin from four preparations.

N Engl J Med. 1971 Dec 9;285(24):1344-7. doi: 10.1056/NEJM197112092852403.

Therapeutic non-equivalence of digoxin tablets in the United Kingdom: correlation with tablet dissolution rate.

Br Med J. 1973 Dec 29;4(5895):763-6. doi: 10.1136/bmj.4.5895.763.