Literature DB >> 25081821

EANM guideline for the preparation of an Investigational Medicinal Product Dossier (IMPD).

Sergio Todde1, Albert D Windhorst, Martin Behe, Guy Bormans, Clemens Decristoforo, Alain Faivre-Chauvet, Valentina Ferrari, Antony D Gee, Balazs Gulyas, Christer Halldin, Petra Kolenc Peitl, Jacek Koziorowski, Thomas L Mindt, Martina Sollini, Johnny Vercouillie, James R Ballinger, Philip H Elsinga.   

Abstract

The preparation of an Investigational Medicinal Product Dossier (IMPD) for a radiopharmaceutical to be used in a clinical trial is a challenging proposition for radiopharmaceutical scientists working in small-scale radiopharmacies. In addition to the vast quantity of information to be assembled, the structure of a standard IMPD is not well suited to the special characteristics of radiopharmaceuticals. This guideline aims to take radiopharmaceutical scientists through the practicalities of preparing an IMPD, in particular giving advice where the standard format is not suitable. Examples of generic IMPDs for three classes of radiopharmaceuticals are given: a small molecule, a kit-based diagnostic test and a therapeutic radiopharmaceutical.

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Year:  2014        PMID： 25081821     DOI： 10.1007/s00259-014-2866-8

Source DB:  PubMed          Journal:  Eur J Nucl Med Mol Imaging        ISSN： 1619-7070            Impact factor:   9.236


  2 in total

1.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

2.  Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals.

Authors:  Philip Elsinga; Sergio Todde; Ivan Penuelas; Geerd Meyer; Brit Farstad; Alain Faivre-Chauvet; Renata Mikolajczak; Gerrit Westera; Tanja Gmeiner-Stopar; Clemens Decristoforo
Journal:  Eur J Nucl Med Mol Imaging       Date:  2010-05       Impact factor: 9.236
  2 in total
  14 in total

Review 1.  Using PET for therapy monitoring in oncological clinical trials: challenges ahead.

Authors:  C M Deroose; S Stroobants; Y Liu; L K Shankar; P Bourguet
Journal:  Eur J Nucl Med Mol Imaging       Date:  2017-04-27       Impact factor: 9.236

Review 2.  Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.

Authors:  Aruna Korde; Renata Mikolajczak; Petra Kolenc; Penelope Bouziotis; Hadis Westin; Mette Lauritzen; Michel Koole; Matthias Manfred Herth; Manuel Bardiès; Andre F Martins; Antonio Paulo; Serge K Lyashchenko; Sergio Todde; Sangram Nag; Efthimis Lamprou; Antero Abrunhosa; Francesco Giammarile; Clemens Decristoforo
Journal:  EJNMMI Radiopharm Chem       Date:  2022-07-19

3.  Good manufacturing practice production of [(68)Ga]Ga-ABY-025 for HER2 specific breast cancer imaging.

Authors:  Irina Velikyan; Anders Wennborg; Joachim Feldwisch; Henrik Lindman; Jörgen Carlsson; Jens Sörensen
Journal:  Am J Nucl Med Mol Imaging       Date:  2016-04-24

4.  Guidance on validation and qualification of processes and operations involving radiopharmaceuticals.

Authors:  S Todde; P Kolenc Peitl; P Elsinga; J Koziorowski; V Ferrari; E M Ocak; O Hjelstuen; M Patt; T L Mindt; M Behe
Journal:  EJNMMI Radiopharm Chem       Date:  2017-06-29

Review 5.  68Ga-Based radiopharmaceuticals: production and application relationship.

Authors:  Irina Velikyan
Journal:  Molecules       Date:  2015-07-16       Impact factor: 4.411

6.  Development of [225Ac]Ac-PSMA-I&T for Targeted Alpha Therapy According to GMP Guidelines for Treatment of mCRPC.

Authors:  Eline L Hooijman; Yozlem Chalashkan; Sui Wai Ling; Figen F Kahyargil; Marcel Segbers; Frank Bruchertseifer; Alfred Morgenstern; Yann Seimbille; Stijn L W Koolen; Tessa Brabander; Erik de Blois
Journal:  Pharmaceutics       Date:  2021-05-13       Impact factor: 6.321

7.  Radiopharmaceutical Formulation and Preclinical Testing of 68Ga-Labeled DOTA-MGS5 for the Regulatory Approval of a First Exploratory Clinical Trial.

Authors:  Anton A Hörmann; Maximilian Klingler; Christine Rangger; Christian Mair; Clemens Decristoforo; Christian Uprimny; Irene J Virgolini; Elisabeth von Guggenberg
Journal:  Pharmaceuticals (Basel)       Date:  2021-06-16

8.  From preclinical development to clinical application: Kit formulation for radiolabelling the minigastrin analogue CP04 with In-111 for a first-in-human clinical trial.

Authors:  Dariusz Pawlak; Christine Rangger; Petra Kolenc Peitl; Piotr Garnuszek; Michał Maurin; Laura Ihli; Marko Kroselj; Theodosia Maina; Helmut Maecke; Paola Erba; Leopold Kremser; Alicja Hubalewska-Dydejczyk; Renata Mikołajczak; Clemens Decristoforo
Journal:  Eur J Pharm Sci       Date:  2016-01-27       Impact factor: 4.384

9.  Preclinical pharmacokinetics, biodistribution, radiation dosimetry and toxicity studies required for regulatory approval of a phase I clinical trial with (111)In-CP04 in medullary thyroid carcinoma patients.

Authors:  Theodosia Maina; Mark W Konijnenberg; Petra KolencPeitl; Piotr Garnuszek; Berthold A Nock; Aikaterini Kaloudi; Marko Kroselj; Katja Zaletel; Helmut Maecke; Rosalba Mansi; Paola Erba; Elisabeth von Guggenberg; Alicja Hubalewska-Dydejczyk; Renata Mikolajczak; Clemens Decristoforo
Journal:  Eur J Pharm Sci       Date:  2016-05-14       Impact factor: 4.384

10.  High-throughput high-volume nuclear imaging for preclinical in vivo compound screening§.

Authors:  Sven Macholl; Ciara M Finucane; Jacob Hesterman; Stephen J Mather; Rachel Pauplis; Deirdre Scully; Jane K Sosabowski; Erwan Jouannot
Journal:  EJNMMI Res       Date:  2017-04-07       Impact factor: 3.138
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