Special considerations concerning regulatory requirements and drug development for peptides and biotech products in the EU

Pharmaceutica Acta Helvetiae

Volumn 71, Issue 6, 1996, Pages 447-458

  Braun, Andrea ^a   Gassmann, Roland ^b   Kraus, Karin ^a   Lorenzi, Giovanna ^c   Weigel, Ulrich ^d  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b Calbiochem Novabiochem AG   (Switzerland)

^c Pharmacia and Upjohn AG   (Switzerland)

^d Sandoz Pharma Ltd   (Switzerland)

Author keywords

Biotech products; Drug development; Peptides; Regulatory dossier; Regulatory procedures

Indexed keywords

BIOLOGICAL PRODUCT; PEPTIDE;

ANIMAL EXPERIMENT; ARTICLE; BIOTECHNOLOGY; CARCINOGENICITY; CHRONIC TOXICITY; DOCUMENTATION; DRUG DEVELOPMENT; DRUG LEGISLATION; DRUG SAFETY; DRUG STABILITY; EUROPEAN UNION; MUTAGENICITY; NONHUMAN; PHARMACODYNAMICS; QUALITY CONTROL; REPRODUCTIVE TOXICITY;

BIOTECHNOLOGY; EUROPEAN UNION; LEGISLATION, DRUG; RECOMBINANT PROTEINS;

EID: 0030455261     PISSN: 00316865     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-6865(96)00053-2     Document Type: Article

References (22)

1. AP-CSP (93) 5, 'Certification of suitability to the monographs of the European Pharmacopoeia' from the Council of Europe Public Health Committee (partial agreement).
2. Arvinte, T., Cudd, A. and Drake, A.F. (1993) The structure and mechanism of formation of human calcitonin fibrils. J. Biol. Chem. 268(9), 6415-6422.
3. CPMP/142/95: Note for guidance on impurities in new drug substances.
4. CPMP/ICH/138/95. Note for guidance of biotechnological products: stability testing of biotechnological/biological products.
5. CPMP/ICH/139/95. Note for guidance of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products.
6. CPMP/ICH/295/95 Draft. ICH consensus guideline: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
7. EC Council Directive 87/22/EEC (1986).
8. EU/III/118/87-EN, Vol. II (1989) The rules governing medicinal products in the European community.
9. EU, Vol. III (1989) The rules governing medicinal products in the European community. Notes to Applicants on the preclinical biological safety testing of medicinal products derived from biotechnology.
10. EU/III/3153/91-EN, Note for guidance: Biotech headings for notice to applicants, Part II.
11. EU/III/3335/92, Final Tripartide ICH guideline. Stability testing of new drug substances and products.
12. EU/III/5370/93, Compilation of texts relating to the submission of data on active ingredients in dossiers for application for marketing authorisation of medicinal products when the European drug master file procedure is used.
13. EU/III/5512/93, Contribution to Part II of the structure of the dossier for applications for marketing authorization - Viral safety studies.
14. EU/III/5944/94, Draft 'Notice to applicants for marketing authorisations for medicinal products for human use in the European Union' from December 1994.
15. Gerhardt, J., Nicholson, G., Frank, H. and Bayer, H. (1984) Automated pre-column derivatization in gas chromatography amino acid analysis via enantiomer labelling. Chromatographia 19, 251-253.
16. Juul, P. (1991) Meaningful evaluation of biotechnology products. In: The Clinical Pharmacology of Biotechnology Products, Proc. of the Esteve Foundation Symp. IV 1990. Reidenberg, Amsterdam, pp. 169-183.
17. Kirby, N. (1993) The clinical testing of biologics. In: M. Mathieu (Ed.), Biologics Development: A Regulatory Overview, Parexel, pp. 101-130.
18. Mutter, M. and Vuilleumier, S. (1989) Protein De Novo Design. Templat-Assembled Synthetic Proteins (TASP). Angew. Chem. 101, 551-571.
19. Orlowski, R.C., Masao, K., Hiromichi, N., Junko, M. and Yoshinobu, Y. (1982) Absorption loss of peptides to the plastic tubes in radio assay of calcitonin and beta-endorphin: Protection by detergents. Jpn. J. Pharmacol. 32(3), 413-418.
20. Röthig, H.-J. (1994). Clinical trials of gene/biotechnology products. Methods Find. Exp. Clin. Pharmacol. 16(7), 539-544.
21. Strand, V. (1994). Are there special considerations relevant to trials of biologic agents? J. Rheumatol. Suppl. 41, 41-45.
22. Woodcock, I. (1991) Design and interpretation of pivotal clinical trials. In: V. Strand, E. Amento and C. Scribner (Eds.), Early Decisions in DMARD development II: Biologic agents in autoimmune disease. Atlanta, Arthritis Foundation, 128-133.