Download Clinical Pharmacology: Current Topics and Case Studies by Markus Müller PDF
By Markus Müller
This revised and prolonged moment variation makes a speciality of present and rising subject matters in drug improvement, their molecular mechanisms of motion in addition to regulatory matters. additionally, in-depth insights into scientific drug learn and trial method are provided at the foundation of concrete case experiences. This up-to-date booklet makes a worthwhile contribution to the sector of scientific Pharmacology and serves as a must have advisor for professors, researchers and complex scholars from academia and pharmaceutical undefined.
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28. 29. 30. 31. 32. 33. 34. A. Bucsics et al. cidTexte=JORFTEXT000031100882&dateTexte=&oldAction=rechJ O&categorieLien=id&idJO=JORFCONT000031100187 I760 – Pharmaceuticals and antitrust: the Italian competition authority fines Roche and Novartis over eur 180 million for cartelizing the sales of two major ophthalmic drugs, Avastin and Lucentis [Internet]. [Cited 28 Aug 2015].
Proposed alternatives are registries and/or administrative (reimbursement) data. Both approaches have a plethora of problems: interoperability and ownership of registries, data privacy issues, channelling and confounding of data in administrative databases, just to name a few. Additionally, such approaches require considerable resources; due to the economies of scale, this is a larger hurdle for small countries. Hopefully, electronic health records will aid in solving some of these problems. While sensible and sensitive regulation and legislation can help deal with issues of privacy, interoperability and data ownership, it remains to be seen if and how nonrandomised data will be acceptable to HTA agencies and payers – or to MAH for that matter, if their products are destined to be discounted or delisted on the basis of such data.
3 25 Regulatory Life Cycle Management of Medicinal Products Each medicinal product has to be launched within 3 year after receiving the marketing authorisation which has been granted; otherwise, the marketing authorisation is cancelled. Further each marketing authorisation has to be renewed once after 5 years. Once on the market, a medicinal product undergoes, on average, about three regulatory life cycle changes per year, so-called variations. Two of these are usually minor, such as a change of the market authorisation holder’s address or, say, minor changes in the quality documentation, but, on average, one variation is expected to be major, such as widening or restriction of indications or insertion of warnings in the summary of product characteristics and the patient information leaflet, or a major change in the manufacturing process.