Biopharmaceuticals regulatory guidelines

In addition, tests for mutagenicity and carcinogenicity are not likely required for most biopharma-ceutical substances. The regulatory guidelines and industrial practices relating to biopharmaceuti-cal preclinical trials thus remain in an evolutionary mode, and each product is taken on a case-by-case basis. An overview of the main preclinical tests undertaken for a sample biopharmaceutical... 

For both small molecules and biopharmaceuticals, regulatory guidelines state that nonclinical safety testing should be conducted in both a rodent and a nonrodent species (ICH M3R2, 2009 ICH S6R1, 2011). For some... 

Like other potential biopharmaceutical products, FDA, Center for Biologies Evaluation and Research (CBER) regulates the production, testing and use of AAV vectors in human clinical trials, in the US. Many regulatory documents are available to help guide the researcher. These documents are available via the Internet on http //www.fda.gov.cber/guidelines.htm. Review of these documents prior to significant work towards production of vector for... 

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 major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

Points-to-Consider document helps industry scientists and regulatory reviewers understand the ICH S6 guideline. In particular, it is helpful for the clarification of case-by-case approaches to preclinical programs depending on the biopharmaceutical type. However, further updates of the Japanese Points-to-Consider document may be needed as newer types of biopharmaceuticals, technologies, and assays have developed. 

The biopharmaceutical industry is a highly regulated industry where many of the activities and tasks performed by company staff are defined by regulations and guidelines issued by international regulatory authorities. The training requirements for clinical staff of pharmaceutical companies or sponsors can be relatively well defined. 

---