- Email: [email protected]
Softshell properties
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by means of concise description of the pre-clinical regulatory requirements for each phase of the development programme and how, when a study is complete, to communicate the results of the research to the exacting world of the clinical scientist with the agreement of the sponsor, of course. The lilt of contributors is extensive and impressive and experienced cllnlcal researchers may find the challenge of matching chapter with authors(s) impossible to overcome. The impact on the book as a whole, however, could have been arguably improved by informing the reader which author contributed to which chapter and by a greater separation between studies in healthy volunteers and studies in patients, The role of the statistician is diluted to an almost passive role despite the fact that experienced clinical researchers depend heavily on their pm-study programme
input, particularly with respect to the number of participating patienls in a study and the section in the protocol (the bible of any study) which relates to the prospective methods of statistical analyses. The role of clinical quality assurance and its unrelenting drive to maximize the quality of the data generated is conspicuous by its near absence, as is the section on the responsibility of the study monitor, who is perhaps the most underrated link between investigators and the sponsor and the most functional member of the investigator-sponsor project team. Here, the role, although relegated to frequent mention is spread thinly across relevant chapters. Who else could describe, and be responsible for, such a variety of items as the site assessment and initiation visits, the regular scheduled site monitoring visits, the site close down visit, the trial master file, source documents and source document verification?
SOFTWARE New version to Fit 5.0) Pversion Cherwell Scientific Publishing, 1996. fl99.08 for Macintosh.
New release SoftShell Properties Chenvell Scientific Publishers, 19%. E319.ou. SoftShell Properties is a new Windows program that predicts 464
TiPS - Dumber 15%(Vol. 17)
good clinical practice and ethics are
derived from the Declnrntion of Helsinki (18th World Medical Assembly 1964,revised Tokyo 1975, Venice 1983 and Hong Kong 1989) and perhaps these should have been lead chapters instead of intended ‘relegation’ to the second half of the book. In the perfect world it should be mandatory for any inexperienced member of a clinical research team to read, and be allowed time to digest, the contents of this book prior to any investigator-sponsor agreement to cooperate, on the basis that it looks on clinical research from the side of the investigator and enables the reader to more fully understand the role of the study in the development plan for the new compound under investigation. H.J. lavier ClinicalDevelopment Support Services, 20 Meadow View, Buntincjford, UK SG@‘Xfl.
REVIEWS
proFit
5.0 is a data analysis and graph plotting package for the Apple Macintosh. In addition to incorporating such features as Applescript, AppleEvents, and QuickDraw GW, the package now has many new features. These include: (1) ‘Preview’ window, to allow the worker to visualize the effects of
varying parameters on functions, and to change data points on curves; (2) new drawing and plottlng features with zooming to 400%; and (3) enhanced syntax and support for users. pro Fit is a versatile, easy-to-use piece of software and a useful resource for those working in research, engineering and education.
chemical properties from a given structure. It includes modules for calculating the molar refractivity (MR), the n-octanol/water partition coefficient (LogP) and Henry’s Law Constant (LogH, an air-to-water partition coefficient). The database contains MR data on 1404structures and LogP data on 4467 structures; a
database of 500 structures comes with the LogH module. The databases contain literature references for experimental data and can be searched by any text field, e.g. chemical name and formula. The SoftShell Properties package requires Windows 3.1,95 or NT and about 16MBRAM.
0
0
K
s
by means of concise description of the pre-clinical regulatory requirements for each phase of the development programme and how, when a study is complete, to communicate the results of the research to the exacting world of the clinical scientist with the agreement of the sponsor, of course. The lilt of contributors is extensive and impressive and experienced cllnlcal researchers may find the challenge of matching chapter with authors(s) impossible to overcome. The impact on the book as a whole, however, could have been arguably improved by informing the reader which author contributed to which chapter and by a greater separation between studies in healthy volunteers and studies in patients, The role of the statistician is diluted to an almost passive role despite the fact that experienced clinical researchers depend heavily on their pm-study programme
input, particularly with respect to the number of participating patienls in a study and the section in the protocol (the bible of any study) which relates to the prospective methods of statistical analyses. The role of clinical quality assurance and its unrelenting drive to maximize the quality of the data generated is conspicuous by its near absence, as is the section on the responsibility of the study monitor, who is perhaps the most underrated link between investigators and the sponsor and the most functional member of the investigator-sponsor project team. Here, the role, although relegated to frequent mention is spread thinly across relevant chapters. Who else could describe, and be responsible for, such a variety of items as the site assessment and initiation visits, the regular scheduled site monitoring visits, the site close down visit, the trial master file, source documents and source document verification?
SOFTWARE New version to Fit 5.0) Pversion Cherwell Scientific Publishing, 1996. fl99.08 for Macintosh.
New release SoftShell Properties Chenvell Scientific Publishers, 19%. E319.ou. SoftShell Properties is a new Windows program that predicts 464
TiPS - Dumber 15%(Vol. 17)
good clinical practice and ethics are
derived from the Declnrntion of Helsinki (18th World Medical Assembly 1964,revised Tokyo 1975, Venice 1983 and Hong Kong 1989) and perhaps these should have been lead chapters instead of intended ‘relegation’ to the second half of the book. In the perfect world it should be mandatory for any inexperienced member of a clinical research team to read, and be allowed time to digest, the contents of this book prior to any investigator-sponsor agreement to cooperate, on the basis that it looks on clinical research from the side of the investigator and enables the reader to more fully understand the role of the study in the development plan for the new compound under investigation. H.J. lavier ClinicalDevelopment Support Services, 20 Meadow View, Buntincjford, UK SG@‘Xfl.
REVIEWS
proFit
5.0 is a data analysis and graph plotting package for the Apple Macintosh. In addition to incorporating such features as Applescript, AppleEvents, and QuickDraw GW, the package now has many new features. These include: (1) ‘Preview’ window, to allow the worker to visualize the effects of
varying parameters on functions, and to change data points on curves; (2) new drawing and plottlng features with zooming to 400%; and (3) enhanced syntax and support for users. pro Fit is a versatile, easy-to-use piece of software and a useful resource for those working in research, engineering and education.
chemical properties from a given structure. It includes modules for calculating the molar refractivity (MR), the n-octanol/water partition coefficient (LogP) and Henry’s Law Constant (LogH, an air-to-water partition coefficient). The database contains MR data on 1404structures and LogP data on 4467 structures; a
database of 500 structures comes with the LogH module. The databases contain literature references for experimental data and can be searched by any text field, e.g. chemical name and formula. The SoftShell Properties package requires Windows 3.1,95 or NT and about 16MBRAM.