SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE
In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review article.
2. Azeem S and Sharma S, et al. Immediate release drug delivery systems: a review. Int J Biopharm Toxicol Res. 2011;1(1):24-46.
3. Lawrance MJ. Monographs & Excipients. In: Convection USP, editor. US 2008.
4. Wiley-Liss inc. The American Pharmacists Association. J Pharm Sci. 2000; 97:1350-60.
5. Carstensen JT, Rhodes CT. Drug Stability: Principles and Practices. 3rd ed; 2006. p. 227-35.
6. Expert Consultation for 2nd Addendum to the 3rd Edn of the Guidelines for Drinking-water Quality. Geneva; 15-19 May 2006.
7. Wiley-Liss inc. The American Pharmacists Association. J Pharm Sci. 2000; 97:1350-60.
8. WHO drug information book, Malta, Vol 12, 3rd ed; 1998.
9. Ashara KC, Paun JS, Soniwala MM, Chavda JR and Badjatiya JK. Nanoparticulate drug delivery system: A novel approach, International Journal of Drug Regulatory Affairs. 2013; 1(2): 39-48.
10. Patel R, Patel KR, Patel NM. Supac guidance for immediate release solid oral dosage forms. Internationale Pharmaceutica Sciencia. 2012; 2(2):35-44.
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