Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource
Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about regis...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Tett, Susan E. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
1998 |
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| Anmerkung: |
© The Drug Information Association, Inc 1998 |
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| Übergeordnetes Werk: |
Enthalten in: Therapeutic innovation & regulatory science - [New York] : Springer Nature, 2013, 32(1998), 3 vom: Juli, Seite 693-710 |
|---|---|
| Übergeordnetes Werk: |
volume:32 ; year:1998 ; number:3 ; month:07 ; pages:693-710 |
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| DOI / URN: |
10.1177/009286159803200310 |
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| 520 | |a Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. | ||
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10.1177/009286159803200310 doi (DE-627)SPR03890750X (SPR)009286159803200310-e DE-627 ger DE-627 rakwb eng Tett, Susan E. verfasserin aut Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource 1998 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Drug Information Association, Inc 1998 Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. Holford, Nicholas H. G. aut McLachlan, Andrew J. aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 32(1998), 3 vom: Juli, Seite 693-710 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:32 year:1998 number:3 month:07 pages:693-710 https://dx.doi.org/10.1177/009286159803200310 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 32 1998 3 07 693-710 |
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10.1177/009286159803200310 doi (DE-627)SPR03890750X (SPR)009286159803200310-e DE-627 ger DE-627 rakwb eng Tett, Susan E. verfasserin aut Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource 1998 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Drug Information Association, Inc 1998 Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. Holford, Nicholas H. G. aut McLachlan, Andrew J. aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 32(1998), 3 vom: Juli, Seite 693-710 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:32 year:1998 number:3 month:07 pages:693-710 https://dx.doi.org/10.1177/009286159803200310 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 32 1998 3 07 693-710 |
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10.1177/009286159803200310 doi (DE-627)SPR03890750X (SPR)009286159803200310-e DE-627 ger DE-627 rakwb eng Tett, Susan E. verfasserin aut Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource 1998 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Drug Information Association, Inc 1998 Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. Holford, Nicholas H. G. aut McLachlan, Andrew J. aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 32(1998), 3 vom: Juli, Seite 693-710 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:32 year:1998 number:3 month:07 pages:693-710 https://dx.doi.org/10.1177/009286159803200310 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 32 1998 3 07 693-710 |
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10.1177/009286159803200310 doi (DE-627)SPR03890750X (SPR)009286159803200310-e DE-627 ger DE-627 rakwb eng Tett, Susan E. verfasserin aut Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource 1998 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Drug Information Association, Inc 1998 Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. Holford, Nicholas H. G. aut McLachlan, Andrew J. aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 32(1998), 3 vom: Juli, Seite 693-710 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:32 year:1998 number:3 month:07 pages:693-710 https://dx.doi.org/10.1177/009286159803200310 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_121 GBV_ILN_150 AR 32 1998 3 07 693-710 |
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Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. © The Drug Information Association, Inc 1998 |
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Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. © The Drug Information Association, Inc 1998 |
| abstract_unstemmed |
Abstract A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3–4, 1997 to discuss the role of population pharmacokinetics and pharmacodynamics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmaco-kinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patientsPopulation pharmacokinetic and pharmacodynamic studies are able to ‘fill in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribingExpertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the regionThe use of the population approach by the pharmaceutical industry needs to be encour-aged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, andDevelopment of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels. © The Drug Information Association, Inc 1998 |
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