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HOW TO IMPROVE QWBRLG STRATEGY FOR THE FUTURE ?

4 – 5 February, GMP meeting, Paris. HOW TO IMPROVE QWBRLG STRATEGY FOR THE FUTURE ? ANABAS  : A ROUTINE TOOL FOR AN ACCURA TE, RELIABLE AND REPRODUCIBLE ASSESSMENT IN Q UANTITATIVE W HOLE B ODY A UTARADIOGRAPHY . P. Dupont 1 , W. Maio 1 , Y. Collenot 2 and Jo. Simiand 1

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HOW TO IMPROVE QWBRLG STRATEGY FOR THE FUTURE ?

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  1. 4 – 5 February, GMP meeting, Paris HOW TO IMPROVE QWBRLG STRATEGY FOR THE FUTURE ? ANABAS : A ROUTINE TOOL FOR AN ACCURATE, RELIABLE AND REPRODUCIBLE ASSESSMENT IN QUANTITATIVE WHOLE BODY AUTARADIOGRAPHY. P. Dupont1, W. Maio1, Y. Collenot2 and Jo. Simiand1 1 Sanofi~Synthelabo Recherche, 195 route d'Espagne, F-31036, Toulouse cedex 2 Sanofi~Synthelabo Recherche, 371 rue du Professeur J. Blayac, F-34481, Montpellier cedex 04

  2. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Introduction • Previous presentations of the development of an image registration software has been done during the US WBA meetings in St Louis in 1998, in New Orleans in 2001, in London in April 2002 and in Orlando in April 2003. • Basic statements are: • Quantitative data for tissue distribution studies are obtained from computer assisted methods (mainly RLG and DNA) and these data have been well correlated with data issued from LSC, • It is sometimes difficult and even not possible to assess, with these computer assisted methods, to quantitative measurements in tissues or organs (especially when low RT levels occurred in long term sampling times), • There is no available method based on the determination of outlines of ROI directly issued from tissue localization on the image of the specimen (section) and not from the distribution of RT on the image of the autoradiogram.

  3. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Actual situation

  4. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Actual situation

  5. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Actual situation (Cont’d)

  6. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Actual situation (Cont’d)

  7. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris MPK requirements Create a new application • Under a real image analysis environment dedicated to image registration and to quantification, • Independent of the platforms and of the owner file formats, • In a GLP environment integrating 21CFR part 11 recommendation from FDA (users access security, data tracking, audit trail, …).

  8. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris AnaBas development • Based on use of the image analysis tools extracted from Visilog (Noesis, Les Ulis, France), • Use of C++ for interfaces and scripts and Visual C for registration algorithm, • The algorithm of registration is based on extraction of a pattern (4 corner cross markers) in a bounding box of 200  200 pixels from the image of the section and correlation to the corresponding pattern on the autoradiogram, • The algorithm of quantification is based on the inverse equation of transformation of PSL/mm2 into OD from Tina software (sources given by Raytest, Straubenhardt, Germany).

  9. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Previous steps before using AnaBas • Drawing cross markers with radioactive ink at each corner of the section during identification, • Acquisition of the image of the autoradiogram from BAS/FLA systems • (Fuji format) or any else RLG system, or from DNC ( or µImager systems), • Calibration (blood standard scale, IS or ES) using Tina/AIDA or dedicated softwares in order to assess to slope and to Bkg values for LOQ determination, • Cut of autoradiogram (at a predefined size) and save as non compressed TIFF files (16 bits coded) or im5 (Visilog format) to avoid loss of information, • Acquisition of the digital image of the anatomical section, in a "one to one" ratio to prevent image distortion during registration, using a common color flat scanner and save in JPEG format or other, as function of the resolution needed.

  10. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  11. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  12. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  13. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  14. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  15. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  16. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  17. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  18. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  19. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  20. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  21. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  22. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  23. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  24. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  25. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  26. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  27. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  28. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  29. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  30. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  31. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris

  32. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Benefits/Advantages • Increase of accuracy in QTD when using WBA : • - Suppression of the mistake due to human eye error, • - ROI are defined from anatomical localization of tissues or organs across whole body sections and not from the observation of the distribution of the radioactivity on autoradiograms, • Assessment to very low PSL or count values close to the background noise of the detector becomes possible instead of not detectable and/or not quantifiable, • Assessment to small organs and tissue parts without fine dissection process, • Totally interfaced with the WBA interface of Debra LIMS (Lablogic, Sheffield, UK), • Full validated software compliant with GLP requirements and partially • 21 CFR part 11 compliant,

  33. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Close future • About "AnaBas" development : • Integration in the application of a calibration function (expected in • version 3.0), • Integration of an audit trail of the functions of administration of the application in order to be full compliant with 21 CFR part 11 recommendation (expected in version 3.0), • Upgrade with texture, form and color algorithms for direct tissue recognition (version ???) • About steps before using AnaBas : • Acquisition of digital images of non dehydrated sections during cross sectioning (best colors and texture) using a numeric camera, • - Add a radioactive external standard during the inclusion of specimen in CMC to allow three-dimensional re-built.

  34. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Contacts • AnaBas package for quantitative nuclear analysis from Imaging Plate detection is now available at: • Noésis • François Germain • 6 – 8 rue de la Réunion • Les Ulis • F-91955 Courtaboeuf cedex • fg@noesis.fr • AnaBas package for quantitative nuclear analysis from Direct Nuclear detection is now available at: • Biospace Mesures • Marie Meynadier • 10 rue Mercoeur • F-75011 Paris • mmeynadier@biospace.fr

  35. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Acknowledgments To William Maio, in charge of the project for MPK Department How to quantify the invisible ? …

  36. How to improve QWBRLG strategy for the future ? AnaBas : A routine tool for an accurate, reliable and reproducible assessment in Quantitative Whole Body Autoradiography. 4 – 5 February, GMP meeting, Paris Acknowledgments To Yves Collenot, in charge of the project for the IS Department

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