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  • 1
    Electronic Resource
    Electronic Resource
    Population approaches in drug development (1994)
    Springer
    European journal of clinical pharmacology 46 (1994), S. 389-391 
    Details
    ISSN: 1432-1041
    Keywords: Population approach ; Drug development ; software ; pharmacokinetics ; pharmacodynamics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract An expert meeting to discuss population pharmacokinetic/pharmacodynamic software was held in Brussels in November 1993 under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. Recently developed statistical methods offer the possibility of gaining integrated information on pharmacokinetics and response from relatively sparse observational data obtained directly in patients who are being treated with the drug under development. These methods can minimize the need to exclude patient groups and also allow analysis of a variety of unbalanced designs that frequently arise in the evaluation of the relationships between dose or concentration on the one hand and efficacy or safety on the other relationships that do not readily lend themselves to other forms of statistical analysis. The purpose of the Brussels meeting was to evaluate the state of both existing software and software under development, and to specify the needs and wishes of potential users of such software. It was apparent from the meeting that software development for population data analysis is currently a very active area of investigation and that several very good packages are already available, with more in development. The general consensus of the meeting was that well validated, easy to use software was essential to the implementation of the population approach to drug development.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00191898
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    Paper (German National Licenses)
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  • 2
    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
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    Paper (German National Licenses)
    Fulltext
  • 3
    Electronic Resource
    Electronic Resource
    Clinical pharmacokinetics of zidovudine: inter and intraindividual variability and relationship to long term efficacy and toxicity (1993)
    Springer
    European journal of clinical pharmacology 45 (1993), S. 397-407 
    Details
    ISSN: 1432-1041
    Keywords: Zidovudine ; AIDS ; plasma concentration-response ; population pharmacokinetics ; toxicity ; efficacy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The variability of the pharmacokinetics of zidovudine after its oral administration to 36 AIDS patients has been investigated by measuring the plasma and urine levels of zidovudine and its metabolite on Days 1 and 35 of continuous treatment. A two-phase absorption model was first defined from well-documented data in 12 subjects. The population characteristics of the kinetic parameters for both days were estimated by a nonparametric method. On Day 1, the mean (coefficient of variation) volume of distribution of zidovudine was 94.41 (90%), its mean half-life was 0.81 h (107%) and its mean oral clearance was 117l·h−1 (57%) and on Day 35, these values were, respectively, 1121 (139%), 0.75 h (181%) and 295l·h−1 (196%). The results confirm the large interindividual and intraindividual variation in zidovudine kinetics. The four covariates included in the population analysis (body weight, serum haemoglobin, creatinine and bilirubin) did not show clear relationship to the kinetic parameters. Thirty-four subjects were follow-up clinically for 99 days to 367 days after initiation of zidovudine therapy. The relationship between individual kinetic parameters (determined by Bayesian estimation), mean concentration profiles and outcome was studied through survival analysis. Long-term efficacy was defined as the prevention of opportunistic infections, which occurred in 13 patients. No clinical or kinetic variables, nor the individual zidovudine concentration profiles were found to predict the occurrence of an opportunistic infection. Toxicity was defined as a 20%-decrease in serum haemoglobin, which occurred in 13 patients. A significant relationship between mean daily concentration and toxicity was found, with an hazard of occurrence of toxicity 4.3-times larger when the mean steady stade concentration was 0.8 mg·l−1 than 0.6. The results indicate that zidovudine dosage should be individualised.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00315509
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    Paper (German National Licenses)
    Fulltext
  • 4
    Electronic Resource
    Electronic Resource
    New strategies in drug development and clinical evaluation: the population approach (1993)
    Springer
    European journal of clinical pharmacology 45 (1993), S. 93-94 
    Details
    ISSN: 1432-1041
    Keywords: Drug development ; Clinical evaluation ; new strategies
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00315486
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
  • 5
    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
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