Points to Consider when Establishing Drug Product Specifications for Parenteral Microspheres

Author:

Kumar Rajesh,Palmieri Michael J.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference12 articles.

1. Jalil R, Nixon JR. Biodegradable poly (lactic acid) and poly (lactide-co-glycolide) microcapsules: problems associated with preparative techniques and release properties. J Microencapsulation. 1990;7(3):297–325.

2. Tamilvanan S, Babu VR, Kannan K, Basu SK, Sa B. Manufacturing techniques and excipients used during the design of biodegradable polymer-based microspheres containing therapeutic peptide/protein for parenteral controlled drug delivery. PDA J Pharm Sci Technol. 2008;62(2):125–54.

3. D'Souza SS, DeLuca PP. Methods to Assess in vitro drug release from injectable polymeric particulate systems. Pharm Res. 2006;23(3):460–74.

4. http://www.vivitrol.com accessed May 14, 2009.

5. Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. 2000 May. http://www.emea.europa.eu/pdfs/human/ich/036796en.pdf . accessed May 14, 2009.

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