How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider-Reference-Cited by-同舟云学术

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

Published:2013-09-25 Issue:1 Volume:16 Page:15-21
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Schellekens Huub,Stegemann Sven,Weinstein Vera,de Vlieger Jon S. B.,Flühmann Beat,Mühlebach Stefan,Gaspar Rogério,Shah Vinod P.,Crommelin Daan J. A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-013-9533-z.pdf

Reference25 articles.

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3. Holloway C, Mueller-Berghaus J, Lima BS, Lee SL, Wyatt JS, Nicholas JM, et al. Scientific considerations for complex drugs in light of established and emerging regulatory guidance. Ann N Y Acad Sci. 2012;1276:26–36. doi: 10.1111/j.1749-6632.2012.06811 .

4. Chang HI, Yeh MK. Clinical development of liposome-based drugs: formulation, characterization, and therapeutic efficacy. Int J Nanomed. 2012;7:49–60.

5. Mamidi RNVS, Weng S, Stellar S, Wang C, Yu N, Huang T, et al. Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products? Cancer Chemother Pharmacol. 2010;66:1173–84.

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