Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended‐Release Case Study
暂无分享,去创建一个
Liang Zhao | Stephan Schmidt | Rodrigo Cristofoletti | Valvanera Vozmediano | Lanyan Fang | Joshua D. Brown | L. Lesko | S. Ait-Oudhia | V. D. Sharma | Liang Zhao | S. Schmidt | Mirjam N. Trame | Rodrigo Cristofoletti | K. Lingineni | V. Vozmediano | L. Fang | Lawrence J. Lesko | Karthik Lingineni | Sarah Kim | Vishnu D. Sharma | Nashid Farhan | Joshua D. Brown | Sihem Ait‐Oudhia | M. Trame | N. Farhan | Sarah Kim
[1] Andrew C. Hooker,et al. Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models , 2011, The AAPS Journal.
[2] R. Bergstrand,et al. Pharmacokinetic and Pharmacodynamic Evaluation of Metoprolol Controlled Release (CR/ZOK) 50 mg in Young Subjects , 1990, Journal of clinical pharmacology.
[3] P. R. Nixon,et al. Drug release from hydrophilic matrices. 2. A mathematical model based on the polymer disentanglement concentration and the diffusion layer. , 1995, Journal of pharmaceutical sciences.
[4] J. Jonkman,et al. A Pharmacokinetic and Pharmacodynamic Comparison of Metoprolol CR/ZOK with a Conventional Slow Release Preparation , 1990, Journal of clinical pharmacology.
[5] R. Johansson,et al. Pharmacokinetic studies on the selectiveβ1-receptor antagonist metoprolol in man , 1974, Journal of Pharmacokinetics and Biopharmaceutics.
[6] Biykem Bozkurt,et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. , 2013, Circulation.
[7] Lawrence X. Yu,et al. Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration , 2009, The Annals of pharmacotherapy.
[8] Joel S. Owen,et al. Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models , 2014 .
[9] C. Stefanadis,et al. The Interplay of Exercise Heart Rate and Blood Pressure as a Predictor of Coronary Artery Disease and Arterial Hypertension , 2013, Journal of clinical hypertension.
[10] R. Brook,et al. Influence of Metoprolol Dosage Release Formulation on the Pharmacokinetic Drug Interaction With Paroxetine , 2011, Journal of clinical pharmacology.
[11] SRB Allerheiligen,et al. Impact of Modeling and Simulation: Myth or Fact? , 2014, Clinical pharmacology and therapeutics.
[12] P. Lundborg,et al. Pharmacokinetic and pharmacodynamic properties of a new controlled-release formulation of metoprolol: A comparison with conventional tablets , 2004, European Journal of Clinical Pharmacology.
[13] I. Pigeot,et al. Hospitalization rates of generic metoprolol compared with the original beta‐blocker in an epidemiological database study , 2007, Pharmacoepidemiology and drug safety.
[14] P. Binkley,et al. Sustained restoration of autonomic balance with long- but not short-acting metoprolol in patients with heart failure. , 2006, Journal of cardiac failure.
[15] E. Niclas Jonsson,et al. PsN-Toolkit - A collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM , 2005, Comput. Methods Programs Biomed..
[16] K. Shakesheff,et al. The effect of processing variables on morphological and mechanical properties of supercritical CO2 foamed scaffolds for tissue engineering. , 2012, Acta biomaterialia.
[17] J. Dressman,et al. Comparison of Drug Release From Metoprolol Modified Release Dosage Forms in Single Buffer versus a pH-Gradient Dissolution Test , 2006 .
[18] C. Liau,et al. Pharmacokinetic and pharmacodynamic comparison of conventional and controlled release formulations of motoprolol in healthy chinese subjects , 1989, Cardiovascular Drugs and Therapy.
[19] Using METHOCEL Cellulose Ethers for Controlled Release of Drugs in Hydrophilic Matrix Systems , 2019 .
[20] Liang Zhao,et al. Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended‐Release Products , 2019, Journal of clinical pharmacology.
[21] Stephan Schmidt,et al. An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction , 2019, Journal of clinical pharmacology.
[22] N. Peppas,et al. Mechanisms of solute release from porous hydrophilic polymers , 1983 .
[23] Lawrence X. Yu,et al. Innovative approaches for demonstration of bioequivalence: the US FDA perspective. , 2013, Therapeutic delivery.
[24] M. S. Täng,et al. Dose-related effects of metoprolol on heart rate and pharmacokinetics in heart failure. , 2001, Journal of cardiac failure.
[25] R J Keizer,et al. Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose , 2013, CPT: pharmacometrics & systems pharmacology.
[26] P. Lundborg,et al. Pharmacokinetics and pharmacodynamics of controlled-release metoprolol: A comparison with atenolol , 2004, European Journal of Clinical Pharmacology.
[27] Ikuharu Morioka,et al. Blood Pressure Response to Heart Rate During Exercise Test and Risk of Future Hypertension , 2002, Hypertension.
[28] C. Meisel,et al. Impact of the ultrarapid metabolizer genotype of cytochrome P450 2D6 on metoprolol Pharmacokinetics and Pharmacodynamics , 2004, Clinical pharmacology and therapeutics.
[29] M. H. Rubinstein,et al. Studies on the interaction between water and (hydroxypropyl)methylcellulose. , 1997, Journal of pharmaceutical sciences.
[30] Raj M. Khandwalla,et al. Differential Effects of Carvedilol and Metoprolol Succinate on Plasma Norepinephrine Release and Peak Exercise Heart Rate in Subjects With Chronic Heart Failure , 2008, Journal of cardiovascular pharmacology and therapeutics.
[31] P H van der Graaf,et al. Introduction to Population Pharmacokinetic/Pharmacodynamic Analysis With Nonlinear Mixed Effects Models , 2014, CPT: pharmacometrics & systems pharmacology.
[32] A. Setiawati,et al. Pharmacokinetic and Pharmacodynamic Properties of Controlled Release (CR/ZOK) Metoprolol in Healthy Oriental Subjects: A Comparison with Conventional Formulations of Metoprolol and Atenolol , 1990, Journal of clinical pharmacology.
[33] Fach,et al. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in-Congestive Heart Failure (MERIT-HF) , 1999, The Lancet.
[34] M. Metra,et al. Differential Effects of β-Blockers in Patients With Heart Failure , 2000 .
[35] R. Bergstrand,et al. Pharmacokinetic and Pharmacodynamic Comparison of Metoprolol CR/ZOK Once Daily with Conventional Tablets Once Daily and in Divided Doses , 1990, Journal of clinical pharmacology.
[36] M. Metra,et al. Differential effects of beta-blockers in patients with heart failure: A prospective, randomized, double-blind comparison of the long-term effects of metoprolol versus carvedilol. , 2000, Circulation.
[37] Jane A. Linderbaum,et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. , 2013, Journal of the American College of Cardiology.
[38] Ping Gao,et al. Diffusion in HPMC Gels. II. Prediction of Drug Release Rates from Hydrophilic Matrix Extended-Release Dosage Forms , 1995, Pharmaceutical Research.
[39] J. Siepmann,et al. HPMC-Matrices for Controlled Drug Delivery: A New Model Combining Diffusion, Swelling, and Dissolution Mechanisms and Predicting the Release Kinetics , 1999, Pharmaceutical Research.
[40] Linda S. Henderson,et al. Controlled-release carvedilol in the management of systemic hypertension and myocardial dysfunction , 2008, Vascular health and risk management.
[41] N. Miyai,et al. Tatsuo Shiraishi and Hypertension Blood Pressure Response to Heart Rate During Exercise Test and Risk of Future , 2002 .
[42] C. Regårdh,et al. Plasma Concentrations and Beta‐Blocking Effects in Normal Volunteers After Intravenous Doses of Metoprolol and Propranolol , 1980, Journal of cardiovascular pharmacology.
[43] Thomas O'Hara,et al. A REVIEW OF METHODS USED TO COMPARE DISSOLUTION PROFILE DATA , 1998 .