Theories of Dissolution: Diffusion Layer Model
Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model
Factors Affecting Dissolution: Particle Size and Effective Surface Area
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Factors Influencing Drug Absorption: Drug Dissolution
Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH
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Fasheng Li1, Beverly Nickerson2, Les Van Alstine1
1Pharmaceutical Sciences Statistics, Pfizer Research and Development, Groton, Connecticut, USA.
制药产品的溶解规格的设定对于监管部门的批准至关重要. 本文概述了在建立这些关键的药物释放和稳定性质量指标时所涉及的统计方法和科学判断.
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