Generic antibiotics in Japan

Journal of Infection and Chemotherapy

Volumn 18, Issue 4, 2012, Pages 421-427

  Fujimura, Shigeru ^a,b   Watanabe, Akira ^a  

^a TOHOKU UNIVERSITY   (Japan)

^b TOHOKU PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

Antibiotics; Generic antibiotics; PK PD

Indexed keywords

AMPHOTERICIN B; ANTIBIOTIC AGENT; CEFOTIAM; CEFTAZIDIME; CLARITHROMYCIN; GENERIC DRUG; IMIPENEM; LEVOFLOXACIN; MEROPENEM; TEICOPLANIN; VANCOMYCIN;

AREA UNDER THE CURVE; BACTERIAL MENINGITIS; BIOEQUIVALENCE; DRUG COST; DRUG FORMULATION; DRUG INDICATION; DRUG MEGADOSE; DRUG POTENCY; DRUG SOLUBILITY; DRUG USE; ESCHERICHIA COLI; FEBRILE NEUTROPENIA; HELICOBACTER INFECTION; INFECTION; JAPAN; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MINIMUM INHIBITORY CONCENTRATION; PLASMA CONCENTRATION-TIME CURVE; PNEUMONIA; PRESCRIPTION; PSEUDOMONAS AERUGINOSA; REVIEW; SEPSIS; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE;

EID: 84865124770     PISSN: 1341321X     EISSN: 14377780     Source Type: Journal    
DOI: 10.1007/s10156-012-0437-0     Document Type: Review

References (19)

1. RG Frank 2007 The ongoing regulation of generic drugs N Engl J Med 357 1993 1996 18003956 10.1056/NEJMp0781931:CAS:528:DC%2BD2sXhtlWis73E (Pubitemid 350106706)
2. MG Duerden DA Hughes 2010 Generic and therapeutic substitutions in the UK: are they a good thing? Br J Clin Pharmacol70 335 341 20716231 10.1111/j.1365-2125.2010.03718.x
3. Ministry of Health, Labour and Welfare, Japan. Survey of generic drugs 2011. 2011.http://www.mhlw.go.jp/bunya/iryou/kouhatu-iyaku/dl/111205-01.pdf.
4. G Steinkraus R White L Friedrich 2007 Vancomycin MIC creep in non-vancomycin-intermediate Staphylococcus aureus(VISA), vancomycin-susceptible clinical methicillin-resistant S. aureus (MRSA) blood isolates from 2001-05 J AntimicrobChemother 60 788 794 17623693 10.1093/jac/dkm258 1:CAS:528: DC%2BD2sXht1ygtbjM (Pubitemid 47434257)
5. Ministry of Health Labour Welfare. Vancomycin hydrochloride. The Japanese Pharmacopoeia. 15th ed. Tokyo: Ministry ofHealth, Labour and Welfare; 2006. p. 865.
6. United States Pharmacopeial Convention, Inc. Chemistry and compendia requirements; vancomycin. Approved drug productsand legal requirements, vol. III. 21st ed. Montvale: Micromedex USP DI; 2001. p. IV/567-8.
7. S Fujimura A Watanabe K Fuse T Kikuchi K Gomi Y Tokue 2008 In vitro susceptibility of clinical isolates ofmethicillin-resistant Staphylococcus aureus (MRSA) to manufactured generic drugs compared with the brand vancomycin Int JAntimicrob Agents 31 391 392 18308516 10.1016/j.ijantimicag.2008.01.002 1:CAS:528:DC%2BD1cXjs1Kgt7k%3D (Pubitemid 351400375)
8. S Fujimura K Fuse H Takane Y Nakano K Gomi T Kikuchi, et al. 2011 Antibacterial effects of brand-name teicoplanin andgeneric products against clinical isolates of methicillin-resistant Staphylococcus aureus J Infect Chemother 17 30 3320665064 10.1007/s10156-010-0094-0 1:CAS:528: DC%2BC3MXhvV2itbY%3D
9. Japan Antibiotics Research Association: teicoplanin for injection. Requirements for antibiotics products of Japan.Tokyo: Jiho Co.; 2000. p. II-39.
10. MD Tacca G Pasqualetti AD Paolo A Virdis G Massimetti G Gori, et al. 2009 Lack of pharmacokinetic bioequivalencebetween generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers Br J ClinPharmacol 68 34 42 19660001 10.1111/j.1365-2125.2009.03399.x
11. V Petraitis R Petraitience P Lin K Calis AM Kelaher HA Muray, et al. 2005 Efficacy and safety of generic amphotericinb in experimental pulmonary aspergillosis Antimicrob Agents Chemother 49 1642 1645 15793161 10.1128/AAC.49.4.1642-1645.20051:CAS:528:DC%2BD2MXjt1Gjt7c%3D (Pubitemid 40463411)
12. Ministry of Health, Labour and Welfare, Japan. Survey of medical care activities in public health insurance 2009.2009. http://www.mhlw.go.jp/english/ database/db-hss/dl/smcaphi-2009.pdf.
13. C Chu E Rudant M Bonvalet H Agostini P Cavalie L Bonhomme-Faivre, et al. 2011 Generic drug prescriptions followinghospital discharge: a prospective study in France Eur J Intern Med 22 45 49 10.1016/j.ejim.2011.01.016
14. ZN Mammo JG Flanagan DF James GE Trope 2012 Generic versus brand-name North American topical glaucoma drops Can JOphthalmol 47 55 61 22333853
15. BA Chabner 2011 Drug shortages: a critical challenge for the generic-drug market N Engl J Med 365 2147 2149 2204016710.1056/NEJMp1112633 1:CAS:528:DC%2BC3MXhs1WqsL3M
16. Pharmacy blog. Why a Boehringer unit really has drug shortages. http://pharmacyblogbuy.com/tag/bedford-laboratories.
17. CH Kefalas AA Ciociola 2011 The FDA's generic-drug approval process: similarities to and differences from brand-namedrugs Am J Gastroenterol 106 1018 1021 21637264 10.1038/ajg.2011.29
18. A Van der Meersch A Dechartres P Ravaud 2011 Quality of reporting of bioequivalence trials comparing generic to brandname drugs: a methodological systematic review PLoS ONE 6 1 7
19. AK Singh SS Narsipur 2011 Cyclosporine: a commentary on brand versus generic formulation exchange J Transplant 2011 16 10.1155/2011/480642