An Investigation into the Importance of “Very Rapid Dissolution” Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology
暂无分享,去创建一个
Peter Langguth | P. Langguth | Ivan Kovačevi | Jelena Parojči | Marija Tubi-Grozdanis | Ivan Kovačevi | Jelena Parojči | Marija Tubi-Grozdanis
[1] J. Crison,et al. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability , 1995, Pharmaceutical Research.
[2] Gordon L Amidon,et al. A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals , 2002, Journal of clinical pharmacology.
[3] B Agoram,et al. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. , 2001, Advanced drug delivery reviews.
[4] AC Moffat,et al. Clarke's analysis of drugs and poisons , 2003 .
[5] Mei-Ling Chen,et al. Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities. , 2004, Journal of pharmaceutical sciences.
[6] Malcolm Rowland,et al. Clinical pharmacokinetics : concepts and applications , 1989 .
[7] Michael B. Bolger,et al. Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds , 2008, The AAPS Journal.
[8] Jennifer B Dressman,et al. Feasibility of Biowaiver Extension to Biopharmaceutics Classification System Class III Drug Products , 2006, Clinical Pharmacokinetics.
[9] Michael Levin. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System , 2001 .
[10] W. Addicks,et al. Application of the Biopharmaceutical Classification System in Clinical Drug Development—An Industrial View , 2008, The AAPS Journal.
[11] Rowland and Tozer,et al. Comprar Clinical Pharmacokinetics: Concepts and Applications, 4/e | Rowland and Tozer | 9780781750097 | Lippincott Williams & Wilkins , 2010 .