Zobrazeno 1 - 10
of 52
pro vyhledávání: '"Walther Seiler"'
Autor:
Samina Hamilton, Aaron B. Bernstein, Graham Blakey, Vivien Fagan, Tracy Farrow, Debbie Jordan, Walther Seiler, Art Gertel, on behalf of the Budapest Working Group [BWG]
Publikováno v:
Research Integrity and Peer Review, Vol 4, Iss 1, Pp 1-9 (2019)
Abstract Background CORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access us
Externí odkaz:
https://doaj.org/article/a0246b0d073d46dfa12d1b3e724c34b5
Publikováno v:
Medical Writing. 23:281-288
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the guidelines,
Autor:
Walther Seiler
Publikováno v:
Medical Writing. 23:93-95
The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers ar
Publikováno v:
Experimental and Clinical Endocrinology & Diabetes. 102:326-333
Plasma levels of prolactin (PRL) and the butyrophenone neuroleptic benperidol (BPD) were closely followed 0 to 48 h after acute application of 6 mg BPD as intravenous injection, orally as liquid, and orally as tablets in 12 schizophrenic patients usi
Publikováno v:
Medical Writing. 22:147-149
I reached Myth 45 about English in Medical Writing, Vol. 21(1) 2012. Three more have turned up since then, which all fit into the category of language users who rule by whim. All were – as so often...
Publikováno v:
The Quality Assurance Journal. 8:239-246
We describe a principle of reviewing documents, particularly those relating to clinical studies, under constraints of time and/or manpower. This principle can be expressed formally in a manner that shows how to choose which processes to conduct and w
Autor:
Walther Seiler, Paul Woolley
Publikováno v:
Drug Information Journal. 35:259-268
Practical problems of interdepartmental communication involving medical writers are addressed. This contribution will summarize “how to please a medical writer” if you are a project manager, a clinical research associate, a data manager, a statis
Publikováno v:
Annals of the New York Academy of Sciences. 762:468-470
Autor:
Günter Schöllnhammer, M. Langer, A. Hillert, Uwe Barlage, Walther Seiler, Hermann Wetzel, Christoph Hiemke
Publikováno v:
Psychopharmacology. 116:457-463
Pharmacokinetics and bioavailability of benperidol were determined in 13 schizophrenic patients after acute administration of 6 mg benperidol as an intravenous (i.v.) bolus injection, orally as liquid, and orally as tablets using a partially randomiz
Autor:
Walther Seiler, Christoph Hiemke
Publikováno v:
Journal of Liquid Chromatography. 16:2813-2823
An isocratic HPLC method with electrochemical detection for the quantification of homovanillic acid (HVA) is described. The method included automated solid phase extraction on C-18-reversed phase material, followed by separation on a 3-μm Nucleosil