Biological drug

Figure 6 The iterative drug discovery process integrating structural biology, drug design, synthetic chemistry, biological testing, and additional input from other related research areas.

Another hydrophilic polymer that has received attention is poly(vinyl alcohol) (PVA). This material holds tremendous promise as a biological drug delivery device because it is nontoxic, hydrophilic and exhibits good mucoadhesive properties (Peppas, 1987). In one of the first applications of this material, Langer and Folkman (1976) investigated the use of copolymers of PHEMA (Hydron ) and PVA as delivery vehicles for polypeptide drugs. 

FDA (Food and Drug Administration). (1987b). New drug, antibiotic, and biologic drug produce regulations. 21 CFR Parts 312, 314, 511, and 514, Federal Register, 52(53) 8798-8857. 

Pendergast, W. (1984). Biological drug regulation. In The Seventy-fifth Anniversary Commemorative Volume of Food and Drug Law. Edited and Published by the Food and Drug Law Institute, Washington, D.C., pp. 293-305. 

The long-term toxicities of concern are opportunistic infections, lymphoproli-ferative disorders, and immunogenicity, manifesting as tachyphylaxis and/or allergic reactions. Preclinical approaches which serve to identify these as potential hazards to humans of a biologic drug moiety are thus needed. 

Hancock, A.A. (1996) a 1-Adrenoceptor adrenoceptor subtypes a synopsis of their pharmacology and molecular biology. Drug Development Research, 39, 54-107. 

Source Biologic Drug Report, http //www.biologicdrugreport.com/leading.htni [accessed May 25, 2007]. 

Biologies License Applications (BLAs) for therapeutic biologic drugs... 

The CBER regulates nontherapeutic biologies—drugs that are described in Chapter 4—which are not regulated by the CDER. These include the following ... 

This section is limited to drugs regulated under the FD C Act. Biological drugs are considered in the next section. 

Anakinra is the first biologic drug that has been developed specifically as an interleukin (IL)-l receptor antagonist and is derived from an endogenous IL-IRa. The drug blocks the activity of IL-1 in synovial joints, reducing the infiammatory and joint destructive processes associated with rheumatoid arthritis. It is administered subcutaneously and is generally well tolerated. Injection-site reactions are the most commonly reported adverse event. 

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