Biopharmaceutical regulatory aspect

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. 

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,... 

A number of regulatory guidance documents touch on various aspects of the transition from preclinical to clinical study of a novel biopharmaceutical. The primary guidance documents describing the conduct and use of preclinical safety evaluation in supporting the initial clinical trials are as follows ... 

This chapter provides an overview of specific analytical aspects for biopharmaceuticals, and also refers to the quality standards required by regulatory authorities. Due to the wide variety of different product classes in the field of biopharmaceuticals, this overview will be based... 

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