76
Views
1
CrossRef citations to date
0
Altmetric
Antimicrobial Original Research Paper

Comparison of pharmaceutical quality of eight generic ganciclovir injections in China and Cymevene

&
Pages 310-315 | Received 23 Mar 2018, Accepted 20 Aug 2018, Published online: 11 Jan 2019

References

  • Fletcher CV, Balfour HH, Jr. Evaluation of ganciclovir for cytomegalovirus disease. DICP. 1989;23(1):5–12.
  • Erice A. Resistance of human cytomegalovirus to antiviral drugs. Clin Microbiol Rev. 1999;12(2):286–97.
  • Whitley RJ. The use of antiviral drugs during the neonatal period. Clin Perinatol. 2012;39(1):69.
  • Cochereaumassin I, Lehoang P, Lautierfrau M, Zazoun L, Marcel P, Robinet M, et al. Cytomegalovirus retinitis in aids - treatment with intravitreal injections of ganciclovir. Presse Med. 1990;19(28):1313–16.
  • Janoria KG, Mitra AK. Effect of lactide/glycolide ratio on the in vitro release of ganciclovir and its lipophilic prodrug (GCV-monobutyrate) from PLGA microspheres. Int J Pharm. 2007;338(1-2):133–41.
  • Tran TH, Ramasamy T, Poudel BK, Marasini N, Moon BK, Cho HJ, et al. Preparation and characterization of spray-dried gelatin microspheres encapsulating ganciclovir. Macromol Res. 2014;22(2):124–30.
  • Anand O, Yu LX, Conner DP, Davit BM. Dissolution testing for generic drugs: an FDA perspective. AAPS J. 2011;13(3):328–35.
  • Chang RK, Raw A, Lionberger R, Yu L. Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products. AAPS J. 2013;15(3):674–83.
  • Arnet I, Altermatt M, Roggo Y, Schnetzler G. Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia. J Chemother. 2015;27(6):337–42.
  • Lee SL, Saluja B, Garcia-Arieta A, Santos GM, Li Y, Lu S, et al. Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J. 2015;17(5):1285–304.
  • Agudelo M, Vesga O. Therapeutic equivalence requires pharmaceutical, pharmacokinetic, and pharmacodynamic identities: true bioequivalence of a generic product of intravenous metronidazole. Antimicrob Agents Chemother. 2012;56(5):2659–65.
  • Vial J, Cohen M, Sassiat P, Thiebaut D. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Curr Med Res Opin. 2008;24(7):2019–33.
  • Taylor PW, Keenan MHJ. Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane. Curr Med Res Opin. 2006;22(3):603–15.
  • Taylor PW, Arnet I, Fischer A, Simpson IN. Pharmaceutical quality of nine generic orlistat products compared with Xenical (R). Obesity Facts. 2010;3(4):231–37.
  • Gasser UE, Fischer A, Timmermans JP, Arnet I. Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar(R)/Prolopa(R). BMC Pharmacol Toxicol. 2013; 23(14):24.
  • Schito GC, Keenan MH. Predicting the clinical efficacy of generic formulations of ceftriaxone. J Chemother. 2005;17Suppl2:33–40.
  • Higginson R, Parry A. Phlebitis: treatment, care and prevention. Nursing Times. 2011;107(36):18–21.
  • Spivey JF, Singleton D, Sweet S, Storch GA, Hayashi RJ, Huddleston CB, et al. Safety and efficacy of prolonged cytomegalovirus prophylaxis with intravenous ganciclovir in pediatric and young adult lung transplant recipients. Pediatr Transplant. 2007;11(3):312–8.
  • Nalbantsoy A, Karabay-Yavasoglu NU, Deliloglu-Gurhan I. Determination of in vivo toxicity and in vitro cytotoxicity of lipopolysaccharide isolated from Salmonella Enteritidis and its potential use for production of polyclonal antibody. Food Agr Immunol. 2011;22(3):271–81.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.