Generic drug products development

Generic Drug Product Development Solid Oral Dosage Forms, edited by Leon Shargel and Izzy Kanfer... 

Ahmed, S. U., Naini, V, and Wadgaonkar, D. (2005), Scale-up, process validation and technology transfer, in Shargel, L., and Kanfer, I., Eds., Generic Drug Product Development Solid Oral Dosage Form, Marcel Dekker, New York, pp. 95-136. 

Generic Drug Product Development Bioequivalence Issues, edited by Isadore Kanfer and Leon Shargel... 

Act as a constant source for development of value-added generic drug products. 

It is important to note that generic drug products can be developed and approved more quickly than innovator drugs, because clinical trials are not typically required. A 505(b)(1) or 505(b)(2) NDA holder may delay approval of an ANDA due to patent or exclusivity considerations, however. These issues, however, while described briefly later, are beyond the scope of this chapter. 

R., Hauck, W.W. et al., An individual bioequivalence criterion regnlatory considerations, Stat. Med. 19, 2821-2842, 2000 Meyer, M.C., United States Food and Drug Administration requirements for approval of generic drug products, J. Clin. Psychiatry 62 (Suppl. 5), 4-9, 2001 Temple, R., Policy developments in regulatory approval, Stat. Med. 21, 2939-3048, 2002 Gould, A.L, Substantial evidence of effect, J. Biopharm. Stat. 12, 53-77, 2002 Chen, M.L., Panhard, X., and Mentre, F, Evaluation by simulation of tests based on nonlinear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over clinical trials, Stat. Med. 24,1509-1524,2005 Bolton, S., Bioequivalence studies for levothy-roxine, AAPS J. 7, E47-E53, 2005. 

A preservative is a substance that prevents or inhibits microbial growth and extends the shelf life of the drug products. In most pharmaceutical drug products, only a few compounds are typically selected as preservatives. For efficiency, a generic method should be developed for the types of preservatives that are more commonly used. For example, butylated hydroxytoluene (BHT) is an antioxidant commonly used in many solid dosage formulations to retard oxidative degradation of the excipients. 

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