Generic Samples

Related Articles The FRAGAMP study: environmental and genetic factors in Parkinson’s disease, methods and clinical features. Neurol Sci. 2010 Feb;31(1):47-52 Authors: Nicoletti A, Pugliese P, Nicoletti G, Arabia G, Annesi G, De Mari M, Lamberti P, Gallerini S, Marconi R, Epifanio A, Morgante L, Cozzolino A, Barone P, Torchia G, Quattrone A, Zappia M The Fattori di Rischio Ambientali e Genetici Associati alla Malattia di Parkinson (FRAGAMP) study is a multicenter case-control study carried out to evaluate the possible role of environmental and genetic factors in Parkinson’s disease (PD). Cases and controls were enrolled from five Movement Disorder centers in Central-Southern Italy. PD was diagnosed according to Gelb’s criteria while the control groups consisted of the spouses of the enrolled patients or of healthy controls matched by age and area of residence. Cases and controls underwent a standardised questionnaire and a blood sample was taken for molecular analyses. At the end of the study 585 cases and 481 control subjects (287 spouse-controls and 194 generic-controls) were enrolled. Patients had a Hoehn-Yahr score of 2.3 +/- 0.8; 85% of them took levodopa and 47% had motor complications. The FRAGAMP study represents one of the largest case-control studies carried out in Europe to investigate the possible role of environmental and genetic factors in PD. PMID: 19924504 [PubMed - indexed for MEDLINE]

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The FRAGAMP study: environmental and genetic factors in Parkinson’s…

Related Articles Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies. Pharmazie. 2010 Mar;65(3):155-61 Authors: Mishra V, Gupta U, Jain NK Bioequivalence is a vital concern in drug development even more significant in the case of Narrow Therapeutic Index (NTI) drugs. In clinical development of New Chemical Entities (NCE), bioequivalence studies necessitate to be performed when the formulation of the pharmaceutical dosage form has been changed. In vivo pharmacokinetic data can be used as surrogate parameters for in vivo solubility and permeability data. The Biopharmaceutics Classification System (BCS) has emerged as a helpful tool in product development by alluding to the in vivo performance of the active substance. The bio-relevance of the BCS properties and the in vitro release are best expressed through a correlation between in vitro and in vivo data. Recently BCS has been implemented for waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance and can be strategically deployed to save time and resources during generic drug development. The BCS has been adopted as a very useful tool for in vivo drug design and development worldwide, particularly in terms of regulatory standards. A BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs. PMID: 20383933 [PubMed - in process]

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Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence…