Biopharmaceutical studies, drug guidelines

A tabular listing (ETA) of all biopharmaceutical studies conducted is recommended. Brief narrative descriptions (e.g., similar to an abstract for a journal article) are to share relevant features and outcomes of each study that provided important in vitro or in vivo data and information relevant to the BA and/or BE of a drug candidate. These narratives can be abstracted from clinical study reports (i.e., the synopsis of reports prepared according to ICE guideline E3) and should include reference to the full report. A comparison of results across studies, using both text and tables, is to pay particular attention to differences in in vitro dissolution, BA, and comparative BA results. This comparison is to consider... 

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. 

The features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... 

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