For long, the majority of medicinal products developed were small molecules produced by chemical synthesis. Now, the majority are biotechnology-derived, larger molecules. Experience is available, for instance with safety testing of various peptides and proteins, including monoclonal antibodies and vaccines. Medicinal expertise offered also includes in vivo ADME and pharmacology models and in vitro transporter and bioavailability studies.
The level of biocompatibility testing required for medical devices depends on their contact with the body. Medical devices are a diverse and growing category. Even a product for slimming that is ingested, but not absorbed, may be registered in the EU as a medical device.
Systems biology and -omics
Molecular biology and IT are developing and integrating rapidly. Systems biology and ‘-omics’ offer new ways to monitor individual health. The concept of ‘one size fits all’ in healthcare and, possibly, also in nutrition is likely to be refined to the individual level.