Generic drugs/products

Generic drug product equivalence current status, Am. J. Manag. Care, 4, 1183 (1998). 

The study did not provide data on whether, or how, the suggested recommendations might affect brand-name companies and generic apphcant s incentives to enter the market with new brand-name or generic drug products. 

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. 

In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a generic drug product, the biobatch or biobatches are required to be manufactured in production facilities, using production equipment, by production personnel, and the facility is to be in conformance with cGMPs. Accurate documentation is essential so that the production process... 

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. 

An ANDA contains data that, when submitted to the FDA s CDER, Office of Generic Drugs, provide for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the American public. 

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

Abbreviated applications should be sent to the Division of Generic Drug Products. 

Another example in which the excipient reacts with the API is the reaction between lactose and fluoxetine hydrochloride (refer to Figure A15-6 in the Addendum of this chapter). This is a typical example of the Maillard reaction [9]. Another example of the Maillard reaction is presented where Prozac (fluoxetine hydrochloride) and two generic drug products of Prozac were compared at accelerated conditions (40°C/75% RH), and the amount of degradation products (analyzed by HPLC) were found to be very different between the studied formulations (refer to Table 15-2) [10]. The authors... 

Application review and ultimate approval of a generic drug product. This document does... 

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. 

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