Regulatory aspects systems

Workshop on the Biopharmaceutics Classification System Scientific and Regulatory Aspects in Practice, London, 2001. 

The last section of this chapter is devoted to the regulatory aspects of oral drug absorption and in particular to the biopharmaceutics classification system and the relevant FDA guideline. At the very end of the chapter, we mention the difference between randomness and chaotic behavior as sources of the variability encountered in bioavailability and bioequivalence studies. 

In this section, the development of a few of the currently approved protein drugs is examined with emphasis on the choice of expression system, method of purification, and other factors that have had an influence on their commercialization. At least one drug produced through each of the expression systems is considered to illustrate the rationale for the choice and the influence of this choice on production, purification, and regulatory aspects. 

Kanfer, I. (2002) Report on the International Workshop on the Biopharmaceutics Classification System (BCS) scientific and regulatory aspects in practice. Journal of Pharmacy ej Pharmaceutical Sciences,... 

REGULATORY ASPECTS OF HPLC ANALYSIS HPLC SYSTEM AND METHOD VALIDATION... 

The use of plasmid model systems with site-specific defined DNA lesions has proven to be a powerful tool in elucidating the mechanism of TLS. Further studies are needed to elucidate the identity of DNA polymerases involved in TLS across other significant DNA lesions. Moreover, such systems can be also useful to elucidate regulatory aspects of TLS. The big challenge for the future is to harness the power of chemically defined lesions to the development of novel TLS assays in mammalian chromosomes. 

In summary, the criteria for the choice of an expression system in pharmaceutical production [82] are the existing expertise, the available physiological and genetic know-how and tools, the patent situation, and to avoid delays of product launch and commercialization, regulatory aspects like the acceptance by the approving authorities. 

Pilalis, E., Chatziioannour, A., Thomasset, B., Kolisis, R, 2011. An in silico compartmentalized metabolic model of Brassica napus enables the systemic study of regulatory aspects of plant central metabolism. Biotech. Bioeng. 108, 1673-1682. 

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