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

European Journal of Pharmaceutical Sciences

Volumn 91, Issue , 2016, Pages 236-242

  Maina, Theodosia ^a   Konijnenberg, Mark W ^b   KolencPeitl, Petra ^c   Garnuszek, Piotr ^d   Nock, Berthold A ^a   Kaloudi, Aikaterini ^a   Kroselj, Marko ^c   Zaletel, Katja ^c   Maecke, Helmut ^e   Mansi, Rosalba ^e   Erba, Paola ^f   von Guggenberg, Elisabeth ^g   Hubalewska Dydejczyk, Alicja ^h   Mikolajczak, Renata ^d   Decristoforo, Clemens ^g  

^a INSTITUTE OF NANOSCIENCE AND NANOTECHNOLOGY   (Greece)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTRE LJUBLJANA   (Slovenia)

^d NATIONAL CENTRE FOR NUCLEAR RESEARCH   (Poland)

^e UNIVERSITY OF FREIBURG   (Germany)

^f UNIVERSITY HOSPITAL OF PISA   (Italy)

^g INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^h JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

Author keywords

CCK2R targeting of tumours; Clinical translation; Gastrin radioligand; Medullary thyroid cancer; Radionuclide therapy; Radiopharmaceutical development

Indexed keywords

CP04 IN 111; GELATIN SUCCINATE; RADIOPHARMACEUTICAL AGENT; UNCLASSIFIED DRUG; GASTRIN; INDIUM;

ACUTE TOXICITY; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD SAMPLING; CANCER PATIENT; CONTROLLED STUDY; DOSIMETRY; DRUG ABSORPTION; DRUG APPROVAL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG SAFETY; DRUG STABILITY; FEMALE; FREEZE DRYING; GASTROINTESTINAL TRANSIT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; LD50; MALE; METABOLIC STABILITY; MOUSE; NONHUMAN; PRIORITY JOURNAL; RADIOACTIVITY; RAT; SCID MOUSE; SINGLE DRUG DOSE; THYROID MEDULLARY CARCINOMA; TOXICITY TESTING; TUMOR XENOGRAFT; ANIMAL; CARCINOMA; METABOLISM; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PHASE 1 CLINICAL TRIAL (TOPIC); PRECLINICAL STUDY; RADIATION DOSE; THYROID TUMOR; TISSUE DISTRIBUTION; WISTAR RAT;

ANIMALS; CARCINOMA, NEUROENDOCRINE; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG EVALUATION, PRECLINICAL; FEMALE; GASTRINS; HUMANS; INDIUM RADIOISOTOPES; LETHAL DOSE 50; MALE; MICE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RADIATION DOSAGE; RADIOPHARMACEUTICALS; RATS; RATS, WISTAR; THYROID NEOPLASMS; TISSUE DISTRIBUTION;

EID: 84969593736     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2016.05.011     Document Type: Article

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