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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.
In the European Union, a biological medicinal product [31] is one of the active substance(s) produced from or extracted from a biological (living) system, and requires, in addition to physicochemical testing, biological testing for full characterisation. The characterisation of a biological medicinal product is a combination of testing the ...
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Concerning the investigation of the prospects of the industry to contribute to national development in terms of contribution to growth as a leading sector and promotion of self-reliance through net export earnings, findings show that the sector's prospects are poor in this respect as it is not above average for the Nigerian economy.
A former Tennessee teacher who got pregnant after raping a 12-year-old boy pleaded guilty and has been sentenced to 25 years in prison with no parole. On Dec. 20, Alissa McCommon, 39, of Covington ...