220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

174staical trials; SOP should describe the step-by-step actions necessaryto initiate and complete the task required in each job description;SOP assure correctness, consistency and completeness in anoperation and shorten training periods; EC guidelines request thatsponsors “establish detailed SOPs to comply with good clinicalpractice” (or good laboratory practice, good manufacturingpractice resp.) and that the monitor “works according a predeterminedSOP”.starting material EC: “any substance used in the production of a medicinalproduct, but excluding packaging materials”; → seealso batch documentation, finished product.start-up meeting → see prestudy meeting.statement of investigator EC: “administrative document maintainedfor each centre in the trial master file”; elements contain anidentification (name, address) of the investigator, other researchpersonnel assisting, site of centre, laboratory used, ethics committeeresponsible, title and protocol; the st.of I. must also contain alist of obligations, e.g. agreement to comply with the procedures setforh in the protocol, to have read and understood the investigationaldrug brochure, to personally conduct, supervise and dedicate sufficienttime to the study, to adequately inform subjects and obtaintheir consent, to report immediately to the sponsor all serious andunexpected adverse events, to maintain adequate and accurate records,to submit protocol, amendments, and material for informedconsent to the ethics committee, that all personnel involved are informedabout their obligations etc; → see also investigator.statistical test → see data.steady state study Special design of a bioavailability study; requestedwhen plasma concentration cannot be determinedprecisely, e.g. due to problems of sensitivity after single dose,intra-individual variability in plasma concentrations, dose- ortime-dependent pharmacokinetics, extended release productsa.s.o.steering committee Trials which are likely to have a major impacton treatment habits are frequently “supervised” by a s.c.; this committeeis scientifically responsible for the study plan, ev. decisionsconcerning stopping the trial prematurely and interpretation ofstudy results; → see also data and safety monitoring board.stem cell therapy (Immortalised) foetal cells can be transplantedinto damaged tissue and effect repair; research concentrates e.g.,on diseases of the central nervous system, namely Parkinson’s disease,stroke, Huntington’s chorea.stereoisomer Molecules differing only in their three-dimensional(geometric) structure (spatial orientation of the atoms or groups