Criteria for the use of monoclonal antibodies, legislation and ethical considerations.

Abstract:

:The criteria governing the in vivo use of monoclonal antibodies in humans are based upon a number of legal requirements with respect to radiation hygiene, pharmaceutical legislation, radiopharmaceutical legislation and regulations with respect to products arising from biotechnology. This in itself has led to a complicated situation which has undoubtedly restricted the development of valuable diagnostic and potential therapeutic agents. From the ethical point of view there are also important considerations, firstly with respect to the methods of producing antibodies, which has resulted in the discontinuation of the raising of antibodies in murine ascites, and secondly in consideration of the ethics of administering labelled antibodies to healthy volunteers and to patients who may not necessarily benefit personally from the procedure. These factors must be evaluated in the light of the EEC document 'Good clinical practice for trials in medicinal products in the European Community from the CPMP working party on Efficacy of Medicinal Products'.

journal_name

Nucl Med Commun

authors

Cox PH

doi

10.1097/00006231-199308000-00005

subject

Has Abstract

pub_date

1993-08-01 00:00:00

pages

653-7

issue

8

eissn

0143-3636

issn

1473-5628

journal_volume

14

pub_type

杂志文章
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    pub_type: 杂志文章

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    更新日期:1991-09-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1097/00006231-199504000-00161

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    pub_type: 杂志文章

    doi:

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    pub_type: 杂志文章

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    更新日期:1997-12-01 00:00:00

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    doi:10.1097/00006231-198911000-00002

    authors: Langen KJ,Roosen N,Kuwert T,Herzog H,Kiwit JC,Rota Kops E,Muzik O,Bock WJ,Feinendegen LE

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  • Shape analysis of 123I-N-omega-fluoropropyl-2-beta-carbomethoxy-3beta-(4-iodophenyl) nortropane single-photon emission computed tomography images in the assessment of patients with parkinsonian syndromes.

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    journal_title:Nuclear medicine communications

    pub_type: 杂志文章

    doi:10.1097/MNM.0b013e328314b863

    authors: Staff RT,Ahearn TS,Wilson K,Counsell CE,Taylor K,Caslake R,Davidson JE,Gemmell HG,Murray AD

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    journal_title:Nuclear medicine communications

    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1097/MNM.0000000000000116

    authors: Oner AO,Aydin F,Demirelli S,Budak ES,Davran F,Akbas H,Kocak H,Suleymanlar G,Gungor F

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    doi:10.1097/MNM.0000000000000641

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  • The feasibility of 225Ac as a source of alpha-particles in radioimmunotherapy.

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    pub_type: 杂志文章,评审

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