http://hdl.handle.net/10029/4906 Sun, 19 May 2013 20:28:49 GMT 2013-05-19T20:28:49Z http://hdl.handle.net/10029/12622 Title: Evaluation of a procedure to assess the adverse effects of illicit drugs. Authors: Amsterdam, J G C van; Best, W; Opperhuizen, A; Wolff, F A de Abstract: The assessment procedure of new synthetic illicit drugs that are not documented in the UN treaty on psychotropic drugs was evaluated using a modified Electre model. Drugs were evaluated by an expert panel via the open Delphi approach, where the written score was discussed on 16 items, covering medical, health, legal, and criminalistic issues of the drugs. After this face-to-face discussion the drugs were scored again. Taking the assessment of ketamine as an example, it appeared that each expert used its own scale to score, and that policymakers do not score deviant from experts trained in the medical-biological field. Of the five drugs evaluated by the panel, p-methoxy-metamphetamine (PMMA), gamma-hydroxybutyric acid (GHB), and 4-methylthio-amphetamine (MTA) were assessed as more adverse than ketamine and psilocine and psilocybine-containing mushrooms. Whereas some experts slightly adjusted during the assessment procedure their opinion on ketamine and PMMA, the opinion on mushrooms was not affected by the discussion held between the two scoring rounds. All experts rank the five drugs in a similar way on the adverse effect scale i.e., concordance scale of the Electre model, indicating unanimity in the expert panel with respect to the risk classification of these abused drugs. Sun, 01 Feb 2004 00:00:00 GMT http://hdl.handle.net/10029/12622 2004-02-01T00:00:00Z http://hdl.handle.net/10029/8419 Title: Biowaiver monographs for immediate release solid oral dosage forms: prednisolone. Authors: Vogt, M; Derendorf, H; Krämer, J; Junginger, H E; Midha, K K; Shah, V P; Stavchansky, S; Dressman, J B; Barends, D M Abstract: Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks. Mon, 01 Jan 2007 00:00:00 GMT http://hdl.handle.net/10029/8419 2007-01-01T00:00:00Z http://hdl.handle.net/10029/8372 Title: Physical and mental health shortly after a disaster: first results from the Enschede firework disaster study. Authors: Kamp, Irene van; Velden, Peter G van der; Stellato, Rebecca K; Roorda, Jan; Loon, Jeanne van; Kleber, Rolf J; Gersons, Bertold B R; Lebret, Erik Abstract: OBJECTIVES: Two to three weeks after the explosion of a fireworks storage facility in a residential area (May 2000, Enschede, The Netherlands) we assessed the self-reported physical and mental health among those affected by the disaster. METHODS: A questionnaire survey was conducted among 3792 residents, passers-by, and rescue workers, who were involved in and/or affected by the disaster and were > or =18 years of age. RESULTS: At least 30% of those affected by the disaster reported serious physical and mental health problems 2-3 weeks after the explosion. Compared with reference values in the general Dutch population, high scores were found for somatic symptoms, sleeping problems, and restrictions in daily functioning due to physical and mental problems, such as anxiety, depression, and feelings of insufficiency. The strength of these differences varied between groups, based on the level of involvement and the level of being affected. CONCLUSIONS: Results indicate that the fireworks disaster had a substantial impact on the health of those affected by the disaster. The health impact was most pronounced for residents and passers-by and also for rescue workers living in the affected area, but to a lesser degree. Physical and mental health problems were strongly associated with the shocking experiences during and shortly after the disaster. Thu, 01 Jun 2006 00:00:00 GMT http://hdl.handle.net/10029/8372 2006-06-01T00:00:00Z http://hdl.handle.net/10029/7597 Title: Biowaiver monographs for immediate release solid oral dosage forms: cimetidine. Authors: Jantratid, E; Prakongpan, S; Dressman, J B; Amidon, G L; Junginger, H E; Midha, K K; Barends, D M Abstract: Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems were also taken into consideration. On the basis of the overall evidence, a biowaiver can be recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are "rapidly dissolving" as per BCS. Mon, 01 May 2006 00:00:00 GMT http://hdl.handle.net/10029/7597 2006-05-01T00:00:00Z