메뉴 건너뛰기




Volumn 94, Issue 5, 1999, Pages 290-299

Tasks of clinical pharmacology in the early phase of drug development;Aufgaben der klinischen pharmakologie in der fruhen phase der arzneimittelentwicklung

Author keywords

Candidate selection; Confirmatory stage; Drug development; Exploratory stage; Integration of clinical pharmacology

Indexed keywords

NEW DRUG;

EID: 0033563196     PISSN: 07235003     EISSN: None     Source Type: Journal    
DOI: 10.1007/bf03045055     Document Type: Article
Times cited : (6)

References (16)
  • 1
    • 0344730238 scopus 로고    scopus 로고
    • note
    • Allgemeine Verwaltungsvorschrift zur Anwendung der Arzneimittelprüfrichtlinic vom 14. Dezember 1989, Bundesanzeiger 41 Nr. 243 a 1989 und die Neufassung vom 22. Dezember 1994, Bundesanzeiger S 12 569, 1995.
  • 2
    • 0021195933 scopus 로고
    • American college of physicians ethics manual
    • Research, other ethical issues. Recommended reading
    • American College of Physicians Ethics Manual, Part II: Research, other ethical issues. Recommended reading. Ann Int Med 1984;101:262-74.
    • (1984) Ann Int Med , vol.101 , Issue.PART II , pp. 262-274
  • 3
    • 0344298121 scopus 로고    scopus 로고
    • note
    • Arzneimittelgesetz (AMG) vom 24. August 1976 (BGBL IS. 2445. 2448) in der Fassung des Achten Gesetzes zur Änderung des AMB vom 18. Juni 1998 (BGBL IS. 2071).
  • 4
    • 0344298119 scopus 로고    scopus 로고
    • note
    • Deklaration des Weltärztebundes von Helsinki (1964) und ihren erweiterten Fassungen von Tokyo (1975). Venedig (1983). Hongkong (1989) und Somerset West (1996) The World Medical Association, Inc., 01210 kerney-Voltaire, France.
  • 5
    • 0344730237 scopus 로고    scopus 로고
    • Guidelines, medicinal products for human use
    • Efficacy. 3CC 3a, Directive 75/318/EEC as amended (Pharmacokmetic Studies in Man) und 3CC 15a, Directive 65/65/EEC as amended, Directive 75/318/EEC as amended (Investigation of Bioavailability and Bioequivalence)
    • EudraLex, Volume 3C. Guidelines, Medicinal products for human use. Efficacy. 3CC 3a, Directive 75/318/EEC as amended (Pharmacokmetic Studies in Man) und 3CC 15a, Directive 65/65/EEC as amended, Directive 75/318/EEC as amended (Investigation of Bioavailability and Bioequivalence).
    • EudraLex , vol.3 C
  • 6
    • 0039015425 scopus 로고    scopus 로고
    • Kombinatorische synthese. Ein neuer weginder wirkstoffsuche
    • Frobel K, Krämer T. Kombinatorische Synthese. Ein neuer Weginder Wirkstoffsuche. Chemie in unserer Zeit 1996;30:270-85.
    • (1996) Chemie in Unserer Zeit , vol.30 , pp. 270-285
    • Frobel, K.1    Krämer, T.2
  • 8
    • 0343681395 scopus 로고    scopus 로고
    • European requirements for healthy volunteer studies
    • Juillet Y, Abadic E. European requirements for healthy volunteer studies. BIRA J 1998;8:8-11.
    • (1998) BIRA J , vol.8 , pp. 8-11
    • Juillet, Y.1    Abadic, E.2
  • 9
    • 0342811145 scopus 로고
    • Arzneimittelforschung im 20. Jahrhundert. II. Pharmakologische wirsung und therapeutische wirksamkeit
    • Kuhlmann J. Arzneimittelforschung im 20. Jahrhundert. II. Pharmakologische Wirsung und therapeutische Wirksamkeit. CorVas 1989;1/2:54-60.
    • (1989) CorVas , vol.1-2 , pp. 54-60
    • Kuhlmann, J.1
  • 10
    • 0031463291 scopus 로고    scopus 로고
    • Drug research: From the idea to the product
    • Kuhlmann J. Drug research: from the idea to the product. Int J Clin Pharmacol Ther 1997;12:541-52.
    • (1997) Int J Clin Pharmacol Ther , vol.12 , pp. 541-552
    • Kuhlmann, J.1
  • 11
    • 0003753170 scopus 로고
    • General aspects of drug interaction studies
    • Kuhlmann J. ed. Klinische Pharmakologie, München-Bern-Wien-New York: Zuckschwerdt
    • Kuhlmann J. General aspects of drug interaction studies. In: Kuhlmann J. ed. Drug interaction studies during drug development. Klinische Pharmakologie, Vol 11. München-Bern-Wien-New York: Zuckschwerdt. 1994:1.
    • (1994) Drug Interaction Studies during Drug Development , vol.11 , pp. 1
    • Kuhlmann, J.1
  • 12
    • 0342376204 scopus 로고
    • Wirkung und wirksamkiet von arzneimitteln
    • Kuhlmann J. Wirkung und Wirksamkiet von Arzneimitteln. Arzneimitteltherapie 1988;6:43-50.
    • (1988) Arzneimitteltherapie , vol.6 , pp. 43-50
    • Kuhlmann, J.1
  • 13
    • 0031840926 scopus 로고    scopus 로고
    • Interethnic comparisons of the pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin
    • Mück W, Kawano K, et al. Interethnic comparisons of the pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin. Br J Clin Pharmacol 1998;45:583-90.
    • (1998) Br J Clin Pharmacol , vol.45 , pp. 583-590
    • Mück, W.1    Kawano, K.2
  • 14
    • 0342811136 scopus 로고
    • Regulatory aspects of phase I studies from laboratory to patient
    • Shaw JI. Regulatory aspects of phase I studies from laboratory to patient. BIRA J 1989;8:5-7.
    • (1989) BIRA J , vol.8 , pp. 5-7
    • Shaw, J.I.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.