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Volumn , Issue , 2006, Pages 1373-1390

Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products

Author keywords

Drugs versus biologicals versus biotech products; Main regulatory agencies; WHO global role in drugs and biologicals regulation

Indexed keywords


EID: 84889808086     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470117118.ch12a     Document Type: Chapter
Times cited : (1)

References (22)
  • 1
    • 21744451344 scopus 로고    scopus 로고
    • FDA policy on unappproved drug products: Past, present and future
    • Chabra R, Kremzner M E, Killany B J (2005). FDA policy on unappproved drug products: Past, present and future. Ann. Pharmacother. 39:1260-1264.
    • (2005) Ann. Pharmacother. , vol.39 , pp. 1260-1264
    • Chabra, R.1    Kremzner, M.E.2    Killany, B.J.3
  • 2
    • 84889797938 scopus 로고    scopus 로고
    • The road to the biotech revolution: Highligths of 100 years of biologics regulation
    • Bren L (2006). The road to the biotech revolution: Highligths of 100 years of biologics regulation. FDA Consumer Mag. Centen. Edn. 1-7.
    • (2006) FDA Consumer Mag. Centen. Edn , pp. 1-7
    • Bren, L.1
  • 3
    • 33646768080 scopus 로고    scopus 로고
    • Yale University Press, New Haven, CT
    • Offit PA (2005). The Cutter Incident. Yale University Press, New Haven, CT, pp. 83-131.
    • (2005) The Cutter Incident , pp. 83-131
    • Offit, P.A.1
  • 4
    • 58149343093 scopus 로고    scopus 로고
    • Regulation and testing of vaccines
    • B A Plotkin, W A Orenstein (eds.), 4th ed.: Saunders, Philadelphia, PA
    • Baylor N W, Midthun K (2004). Regulation and testing of vaccines. In B A Plotkin, W A Orenstein (eds.), Vaccines, 4th ed.: Saunders, Philadelphia, PA, pp. 1539-1555.
    • (2004) Vaccines , pp. 1539-1555
    • Baylor, N.W.1    Midthun, K.2
  • 5
    • 84889827011 scopus 로고    scopus 로고
    • Structure of ICH
    • Structure of ICH. Available: www.ich.org/cache/html/355-272-1.html.
  • 6
    • 84889851563 scopus 로고    scopus 로고
    • WHO/Drug regulation
    • WHO/Drug regulation. Available: www.who.int/medicines/areas/quality_safety/.
  • 8
    • 84889768516 scopus 로고    scopus 로고
    • From Discovery to Approval. John Wiley and Sons, Inc., New York
    • Ng R (2004). Drugs. From Discovery to Approval. John Wiley and Sons, Inc., New York, pp. 51, 176-178, 212.
    • (2004) Drugs
    • Ng, R.1
  • 9
    • 84889872576 scopus 로고    scopus 로고
    • World Health Organization, Geneva. Regulation of vaccines: Building on existing drug regulatory authorities, WHO/V&B/99
    • World Health Organization, Geneva (1999). Regulation of vaccines: Building on existing drug regulatory authorities. WHO/V&B/99. pp. 1-28.
    • (1999) , pp. 1-28
  • 10
    • 33645278967 scopus 로고    scopus 로고
    • London's disastrous drug trial has serious side effects for research
    • Wadman M (2006). London's disastrous drug trial has serious side effects for research. Nature. 440:388-389.
    • (2006) Nature. , vol.440 , pp. 388-389
    • Wadman, M.1
  • 11
    • 0043208919 scopus 로고    scopus 로고
    • Biopharmaceutical benchmarks
    • Walsh G (2003). Biopharmaceutical benchmarks. Nat. Biotechnol. 21:865-870.
    • (2003) Nat. Biotechnol. , vol.21 , pp. 865-870
    • Walsh, G.1
  • 12
    • 33645846620 scopus 로고    scopus 로고
    • Can super-antibody drugs be tamed?
    • Hopkin M (2006). Can super-antibody drugs be tamed? Nature. 440:855-859.
    • (2006) Nature , vol.440 , pp. 855-859
    • Hopkin, M.1
  • 13
    • 7744233197 scopus 로고    scopus 로고
    • Biopharmaceuticals derived from genetically modified plants
    • Goldstein D A, Thomas J A (2004). Biopharmaceuticals derived from genetically modified plants. QJ Med. 97:705-716.
    • (2004) QJ Med. , vol.97 , pp. 705-716
    • Goldstein, D.A.1    Thomas, J.A.2
  • 14
    • 23744514106 scopus 로고    scopus 로고
    • Molecular farming for new drugs and vaccines. Current perspectives on the production of pharmaceuticals in transgenic plants. The European Union Framework 6 Pharma-Planta Consortium
    • Ma J K, Barros E, Bock R, et al. (2005). Molecular farming for new drugs and vaccines. Current perspectives on the production of pharmaceuticals in transgenic plants. The European Union Framework 6 Pharma-Planta Consortium. EMBO Reports. 6(7):593-599.
    • (2005) EMBO Reports , vol.6 , Issue.7 , pp. 593-599
    • Ma, J.K.1    Barros, E.2    Bock, R.3
  • 15
    • 0034241572 scopus 로고    scopus 로고
    • Biopharmaceuticals benchmarcks
    • Walsh G (2000). Biopharmaceuticals benchmarcks. Nat. Biotechnol. 18:831-833.
    • (2000) Nat. Biotechnol. , vol.18 , pp. 831-833
    • Walsh, G.1
  • 16
    • 30444449389 scopus 로고    scopus 로고
    • Reform on drug regulation-beyond and independiente drug safety board
    • Wayne A, Ray W A, Stein M (2006). Reform on drug regulation-beyond and independiente drug safety board. N. Engl. J. Med. 354:194-200.
    • (2006) N. Engl. J. Med. , vol.354 , pp. 194-200
    • Wayne, A.1    Ray, W.A.2    Stein, M.3
  • 17
    • 84889827233 scopus 로고    scopus 로고
    • About the EMEA-Structure
    • About the EMEA-Structure. Available: www.emea.eu.int.
  • 18
    • 84889795118 scopus 로고    scopus 로고
    • ASEAN Initiatives toward pharmaceutical regulatory harmonization
    • Awang D C M Z B C (2003). ASEAN Initiatives toward pharmaceutical regulatory harmonization. Drug Info. J. 37:55-58.
    • (2003) Drug Info. J. , vol.37 , pp. 55-58
    • Awang, D.C.M.Z.B.C.1
  • 19
    • 33244472381 scopus 로고    scopus 로고
    • Dialogue between companies and the EMEA regarding the centralized procedure from an industry's point of view
    • Heidenreich K (2006). Dialogue between companies and the EMEA regarding the centralized procedure from an industry's point of view. Drug Info. J. 40:15-21.
    • (2006) Drug Info. J. , vol.40 , pp. 15-21
    • Heidenreich, K.1
  • 20
    • 9644302576 scopus 로고    scopus 로고
    • Post marketing surveillance-lack of vigilance, lack of trust
    • Fontanarosa P B, Rennie D, De Angelis C D (2004). Post marketing surveillance-lack of vigilance, lack of trust. JAMA. 292(21):2647-2650.
    • (2004) JAMA , vol.292 , Issue.21 , pp. 2647-2650
    • Fontanarosa, P.B.1    Rennie, D.2    De Angelis, C.D.3
  • 21
    • 31544443578 scopus 로고    scopus 로고
    • Is there still a role for spontanous reporting of adverse drug reactions?
    • Lexchin J (2006). Is there still a role for spontanous reporting of adverse drug reactions? CMAJ. J. 174:191-192.
    • (2006) CMAJ. J. , vol.174 , pp. 191-192
    • Lexchin, J.1
  • 22
    • 33645236972 scopus 로고    scopus 로고
    • Informed consent-a new approach to drug regulation? J
    • Nutt D J (2006). Informed consent-a new approach to drug regulation? J. Psychopharmacol. 20:3-4.
    • (2006) Psychopharmacol. , vol.20 , pp. 3-4
    • Nutt, D.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.