Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

نویسندگان

  • Silke Klick
  • Pim G. Muijselaar
  • Joop Waterval
  • Thomas Eichinger
  • Christian Korn
  • Thijs K. Gerding
  • Alexander J. Debets
  • Gerhardus J. De Jong
چکیده

48 Pharmaceutical Technology FEBRUARY 2005 S. Klick, PhD, is a team manager, Analytical Development, at AstraZeneca R&D (Mölndal Sweden), tel. 146 31 7761758, fax 146 31 7767337, [email protected]. P.G. Muijselaar, PhD, is a senior analytical scientist and T.K. Gerding, PhD, is a manager, Sector Chemical & Pharmaceutical Development, at Solvay Pharmaceuticals (The Netherlands). J. Waterval, PhD, is a group leader, Department of Pharmaceutics at Akzo Nobel, N.V. Organon (The Netherlands), tel. 131 412662070, fax 131 412662524, [email protected]. T. Eichinger, PhD, is a deputy global director, Analytical Sciences Department and C. Korn, PhD, is a manager, Analytical Development, Sanofi-Aventis Frankfurt (Germany). A.J. Debets, PhD, is a general manager of Organon Development GmbH, Akzo Nobel (Germany). C.E. Sänger-van de Griend, PhD, is an associate principal scientist, Analytical Development, at AstraZeneca (Södertälje, Sweden). C. van den Beld, PhD, is the section head, Pharmaceutical Development Section/PDD at Yamanouchi Europe BV (The Netherlands). G.W. Somsen, PhD, is an associate professor and G.J. De Jong, PhD, is a professor, Pharmaceutical Analysis, Utrecht University (The Netherlands).

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تاریخ انتشار 2005