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Volumn , Issue , 2008, Pages 571-583

Significance of Drug Substance Physicochemical Properties in Regulatory Quality by Design

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EID: 77953146976     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9780849360862-21     Document Type: Chapter
Times cited : (27)

References (36)
  • 2
    • 85178625380 scopus 로고    scopus 로고
    • ICH, Q9 Quality Risk Management, ICH, June
    • ICH, Q9 Quality Risk Management, ICH, June 2006.
    • (2006)
  • 3
    • 85178608760 scopus 로고    scopus 로고
    • ICH, Q8 Pharmaceutical Development, ICH, May
    • ICH, Q8 Pharmaceutical Development, ICH, May 2006.
    • (2006)
  • 7
    • 0042452386 scopus 로고
    • Bioavailability and tablet technology
    • Lieberman HA, Lachman L, Schwartz JB, eds, New York: Marcel Dekker
    • Stavchansky R, McGinity J. Bioavailability and tablet technology. In: Lieberman HA, Lachman L, Schwartz JB, eds. Pharmaceutical Dosage Forms: Tablets, Vol. 2. New York: Marcel Dekker, 1989:349-569.
    • (1989) Pharmaceutical Dosage Forms: Tablets , vol.2 , pp. 349-569
    • Stavchansky, R.1    McGinity, J.2
  • 23
    • 0003295607 scopus 로고
    • Preformulation testing
    • Lieberman HA, Lachman L, Schwartz JB, eds, New York: Marcel Dekker
    • Wadke DA, Serajuddin ATM, Jacobson H. Preformulation testing. In: Lieberman HA, Lachman L, Schwartz JB, eds. Pharmaceutical Dosage Forms: Tablets, Vol. 1. New York: Marcel Dekker, 1989:1-71.
    • (1989) Pharmaceutical Dosage Forms: Tablets , vol.1 , pp. 1-71
    • Wadke, D.A.1    Serajuddin, A.T.M.2    Jacobson, H.3
  • 27
    • 0002425795 scopus 로고    scopus 로고
    • Theory and origin of polymorphism
    • Brittain HG, ed, New York: Marcel Dekker
    • Grant DJW. Theory and origin of polymorphism. In: Brittain HG, ed. Polymorphism in Pharmaceutical Solids. New York: Marcel Dekker 1999; 1-34.
    • (1999) Polymorphism in Pharmaceutical Solids , pp. 1-34
    • Grant, D.J.W.1
  • 35
    • 0004284003 scopus 로고    scopus 로고
    • Methods for the characterization of polymorphs and solvates
    • Brittain HG, ed, New York: Marcel Dekker
    • Brittain HG, Grant DJW. Methods for the characterization of polymorphs and solvates. In: Brittain HG, ed. Polymorphism in Pharmaceutical Solids. New York: Marcel Dekker, 1999; 227-78.
    • (1999) Polymorphism in Pharmaceutical Solids , pp. 227-278
    • Brittain, H.G.1    Grant, D.J.W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.