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Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy.
The National Institute for Pharmaceutical Research and Development (NIPRD) is a Nigerian institution charged with developing drugs, biological products, and pharmaceutical raw materials, conducting quality-assurance tests, research for locally manufactured medicines and constituting guidelines for their production.
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
Various other events throughout history have demonstrated the importance of drug and medicine regulation keeping up with scientific advances. In 2006, the challenges associated with TGN 1412 highlighted the shortcomings of animal models and paved the way for further advances in regulation and development for biological products.
The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with the production process and its control. For example: Production process – it can be derived from biotechnology or from other technologies.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
A long-run indicator of the ability of the country to provide food sustenance and avoid malnutrition is the rate of growth of per capita food production; from 1970 to 1990, the rate for Nigeria was 0.25%. [6] Though small, the positive rate per capita may be due to Nigeria's importing of food products.
The similarity-based [4] virtual screening (a kind of ligand-based virtual screening) assumes that all compounds in a database that are similar to a query compound have similar biological activity. Although this hypothesis is not always valid, [ 5 ] quite often the set of retrieved compounds is considerably enriched with actives. [ 6 ]