Library

X
feed icon rss

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    Electronic Resource
    Electronic Resource
    Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies (1996)
    Springer
    European journal of clinical pharmacology 49 (1996), S. 251-254 
    Details
    ISSN: 1432-1041
    Keywords: Population pharmacokinetics ; Pharmacodynamics ; experimental design ; drug development ; clinical trials
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract An expert meeting to discuss issues relating to the design of population pharmacokinetic/pharmacodynamic (PK/PD) studies was held in Brussels in March 1995, under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. The purpose of the meeting was to discuss the experts' experience in designing and performing population PK/PD studies. The topics discussed were current practice, logistical issues, ensuring the accuracy of data, covariate assessment, communication, and protocol design. The main conclusions from the meeting were: 1) a population PK/PD analysis should be one of the objectives of a clinical trial and should not compromise the other objectives; 2) it is particularly important to communicate the purpose of the population PK/PD analysis to the investigators and to convince them of the importance of accurately recording dosing and sampling times; 3) some prior knowledge of the PK and PD models and covariate relationships is necessary for the analysis of sparse phase III data; 4) computer simulation and optimal design measures may be useful in defining sampling times; 5) population methods and objectives must be specified as completely as possible in the protocol. Participants: L. Aarons (UK), L. Balant (Switzerland), P. Bechtel (France), R. Bruno (France), P. Burtin (Switzerland), C. Dubruc (France), E. Fuseau (UK), J. Gabrielsson (Sweden), U. Gundert-Remy (Germany), R. Jochemsen (France), M. Karlsson (Sweden), C. Laveille (France), I. Meineke (Germany), F. Mentré (France), P. Morselli (France), G. Paintaud (France), A. Racine-Poon (Switzerland), J. Rodriguez (Spain), F. Rombout (The Netherlands), M. Rowland (UK), J.-L. Steimer (Switzerland), A. Van Peer (Belgium), S. Vozeh (Switzerland), W. Weber (Germany), B. Wittke (Switzerland) The views expressed by the participants do not necessarily reflect those of the organizations they represent.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00226323
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 2
    Electronic Resource
    Electronic Resource
    The effect of cimetidine on the steady-state pharmacokinetics and pharmacodynamics of warfarin in humans (1999)
    Springer
    European journal of clinical pharmacology 55 (1999), S. 399-404 
    Details
    ISSN: 1432-1041
    Keywords: Key words Warfarin ; Cimetidine ; Drug ; drug interaction
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: The interaction of multiple oral doses of cimetidine on the steady-state pharmacokinetics and pharmacodynamics of warfarin was investigated in six healthy male volunteers. Methods: The subjects were given individually adjusted doses of warfarin to achieve therapeutic levels of prothrombin activity. The established daily maintenance oral dose of warfarin was kept stable throughout the trial and, on study days 8–14, each volunteer received a 800-mg daily dose of cimetidine. The degree of anticoagulant response produced by warfarin was quantified by the determination of both the prothrombin time and factor-VII clotting activity. Results: Cimetidine co-administration had no significant effect on the pharmacokinetics of the more potent S-warfarin but significantly increased by 28% (P 〈 0.05) mean R-warfarin trough plasma concentrations and decreased by 23% (P 〈 0.05) mean R-warfarin apparent clearance. Both prothrombin time and factor-VII clotting activity displayed considerable inter-subject variability and were not significantly affected by concurrent cimetidine treatment. The reduction of apparent clearance of R-warfarin by cimetidine was found to be the effect of inhibition of the formation of warfarin metabolites as determined by apparent formation clearance values (±SD) of R-6-hydroxywarfarin (31.1 ± 7.4 ml/h baseline; 18.5 ± 4.5 ml/h at end of cimetidine treatment; P 〈 0.01), and R-7-hydroxywarfarin (6.9 ± 1.3 ml/h baseline; 4.3 ± 1.1 ml/h at end of cimetidine treatment; P 〈 0.01). Conclusion: Cimetidine stereoselectively affects the steady-state pharmacokinetics of warfarin by inhibiting the disposition of the less potent R-warfarin in humans. However, this interaction is likely to be of minimal clinical significance in most patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050647
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
  • 3
    Electronic Resource
    Electronic Resource
    Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies (1996)
    Springer
    European journal of clinical pharmacology 49 (1996), S. 251-254 
    Details
    ISSN: 1432-1041
    Keywords: Key words Population pharmacokinetics ; Pharmacodynamics; experimental design ; drug development ; clinical trials
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract An expert meeting to discuss issues relating to the design of population pharmacokinetic/pharmacodynamic (PK/PD) studies was held in Brussels in March 1995, under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. The purpose of the meeting was to discuss the experts’ experience in designing and performing population PK/PD studies. The topics discussed were current practice, logistical issues, ensuring the accuracy of data, covariate assessment, communication, and protocol design. The main conclusions from the meeting were: 1) a population PK/PD analysis should be one of the objectives of a clinical trial and should not compromise the other objectives; 2) it is particularly important to communicate the purpose of the population PK/PD analysis to the investigators and to convince them of the importance of accurately recording dosing and sampling times; 3) some prior knowledge of the PK and PD models and covariate relationships is necessary for the analysis of sparse phase III data; 4) computer simulation and optimal design measures may be useful in defining sampling times; 5) population methods and objectives must be specified as completely as possible in the protocol.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00226323
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
    Paper (German National Licenses)
    Fulltext
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...