A pharmacopoeia is an official compendial publication containing medicinal products, their components and composition, thereby providing specifications and quality standards. In this thesis the... Show moreA pharmacopoeia is an official compendial publication containing medicinal products, their components and composition, thereby providing specifications and quality standards. In this thesis the results are presented of an investigation of national pharmacopoeias, six editions and revised reprints, issued in the Netherlands between 1851 and 196,6 were studied and analyzed extensively. The thread in this study was derived from the ambition of the national commissions, who were composing the Pharmacopoeias, to update the text in conformity with ‘the present state of science’.Historical and political aspects of the Netherlands in relation to the editing of the new pharmacopoeia were also described. The legal significance of these official standards was discussed. Surrounding countries issued also a pharmacopoeia on a regular base, so the international context was reviewed as well. Already in 1865 practitioners and scientists promoted the drawing of an international pharmacopoeia. In 1902 harmonization of the potency of highly effective pharmaceuticals was realized by governmental cooperation through the Brussel Convention. This initiated further cooperation between national pharmacopoeia authorities in the League of Nations, after the Second World War in the World Health Organization. In 1964 the Council of Europe published the Convention on the Elaboration of a European Pharmacopoeia. It resulted in the end of publishing independent Dutch editions of the pharmacopoeia. Show less
This thesis focuses on drug development and drug manufacturing for special (small) patient populations in academic institutions. Reaching the patient via the commercial route of marketing approval ... Show moreThis thesis focuses on drug development and drug manufacturing for special (small) patient populations in academic institutions. Reaching the patient via the commercial route of marketing approval (licensing) does mostly not apply to these academic products. The first category of these drugs, the advanced therapy medicinal products (ATMPs), belongs to a new complex group of medicinal products, of which the process of acquiring marketing authorization is relatively unexplored. The second category is the unlicensed tailor made pharmaceutical preparations, which have been used in clinical care in hospitals for decades. Despite long-term experience, it seems that commercialization of these pharmaceutical preparations, via licensing, has never been the main goal for academia. The aim of this thesis is to explore the development field of these academic medicinal products and the role of the academic developers and manufacturers for providing these products for regular patient care whether commercialized or not. Show less
