Michael A. Tortorici
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View article: First‐in‐human study evaluating safety, pharmacokinetics, and pharmacodynamics of lorundrostat, a novel and highly selective aldosterone synthase inhibitor
First‐in‐human study evaluating safety, pharmacokinetics, and pharmacodynamics of lorundrostat, a novel and highly selective aldosterone synthase inhibitor Open
Dysregulation of the mineralocorticoid hormone aldosterone is an increasingly prevalent cause of hypertension. Aldosterone synthase (CYP11B2) shares 93% homology to 11β‐hydroxylase (CYP11B1), which produces cortisol. Lorundrostat, a highly…
View article: Effect of CSL112 (apolipoprotein A‐I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross‐study comparison
Effect of CSL112 (apolipoprotein A‐I [human]) on cholesterol efflux capacity in Japanese subjects: Findings from a phase I study and a cross‐study comparison Open
CSL112 (apolipoprotein A‐I [apoA‐I, human]) is a novel drug in development to reduce the risk of recurrent cardiovascular events following acute myocardial infarction by increasing cholesterol efflux capacity (CEC). This phase I study aime…
View article: Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312)
Pharmacokinetic/pharmacodynamic modeling for dose selection for the first‐in‐human trial of the activated Factor XII inhibitor garadacimab (CSL312) Open
Factor XII (FXII) is a serine protease involved in multiple cascades, including the kallikrein–kinin system. It may play a role in diseases in which the downstream cascades are dysregulated, such as hereditary angioedema. Garadacimab (CSL3…
View article: Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy
Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy Open
The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP wh…
View article: Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A‐I and cholesterol efflux capacity in acute myocardial infarction patients
Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A‐I and cholesterol efflux capacity in acute myocardial infarction patients Open
Aims To characterize relationships between apolipoprotein A‐I (apoA‐I) exposure and cholesterol efflux capacity (CEC) and covariate effects following CSL112 (apoA‐I [human]) administration in an integrated population including acute myocar…
View article: Pharmacometric modeling to explore 4F-PCC dosing strategies for VKA reversal in patients with INR below 2
Pharmacometric modeling to explore 4F-PCC dosing strategies for VKA reversal in patients with INR below 2 Open
The indicated dose of 4-factor prothrombin complex concentrate (4F-PCC) for urgent vitamin K antagonist (VKA) reversal in patients with an international normalized ratio (INR) of 2 to 4 is 25 IU/kg, but there is no indicated dose for INR &…
View article: Pharmacometric Analysis of IgPro10 in Japanese and Non-Japanese Patients With Primary Immunodeficiency
Pharmacometric Analysis of IgPro10 in Japanese and Non-Japanese Patients With Primary Immunodeficiency Open
View article: Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency
Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency Open
Flexible dosing of IgPro20 (Hizentra®, CSL Behring, King of Prussia, Pennsylvania) maintains normal serum immunoglobulin G (IgG) levels in patients with primary immunodeficiencies (PID). Until now, clinical trials testing the pharmacokinet…
View article: Population pharmacokinetic analysis of weekly and biweekly IgPro20 (Hizentra®) dosing in patients with primary immunodeficiency
Population pharmacokinetic analysis of weekly and biweekly IgPro20 (Hizentra®) dosing in patients with primary immunodeficiency Open
The present analysis validated the ability of the previously published popPK model to predict serum IgG concentration time profiles after biweekly subcutaneous IgPro20 administration.
View article: Pharmacokinetic properties of Privigen<sup>®</sup> in Japanese patients with primary immunodeficiency
Pharmacokinetic properties of Privigen<sup>®</sup> in Japanese patients with primary immunodeficiency Open
This prospective, Phase 3, open-label, study (EudraCT: 2016-001631-12) evaluated pharmacokinetic (PK) characteristics of 3-/4-weekly Privigen® (IgPro10, CSL Behring, King of Prussia, PA, USA) in Japanese patients with PID. PK pa…
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guidelines and best practices for paper use, establishing a vendor code of ethics, and engaging our colleagues and other stakeholders in our efforts.
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Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Moderate Renal Impairment Does Not Impact the Ability of CSL112 (Apolipoprotein A‐I [Human]) to Enhance Cholesterol Efflux Capacity
Moderate Renal Impairment Does Not Impact the Ability of CSL112 (Apolipoprotein A‐I [Human]) to Enhance Cholesterol Efflux Capacity Open
CSL112 (apolipoprotein A‐I [human]) is a novel intravenous formulation of plasma‐derived apolipoprotein A‐I (apoA‐I) that enhances cholesterol efflux capacity. Renal impairment is a common comorbidity in acute myocardial infarction patient…
View article: Privigen® has similar pharmacokinetic properties in primary and secondary immune deficiency
Privigen® has similar pharmacokinetic properties in primary and secondary immune deficiency Open
These findings indicate that the disposition of Privigen® is similar during IgG replacement therapy in PID and SID. The results contribute to the understanding of IVIG treatment of SID and may support an evidence-based approach for the use…
View article: Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials
Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials Open
View article: Pharmacokinetics and Safety of CSL112 (Apolipoprotein A‐I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function
Pharmacokinetics and Safety of CSL112 (Apolipoprotein A‐I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function Open
CSL112 (Apolipoprotein A‐I [human]) is an intravenous preparation of apolipoprotein A‐I (apoA‐I), formulated with phosphatidylcholine (PC) and stabilized with sucrose, in development to prevent early recurrent cardiovascular events followi…
View article: Population pharmacokinetics of subcutaneous C1‐inhibitor for prevention of attacks in patients with hereditary angioedema
Population pharmacokinetics of subcutaneous C1‐inhibitor for prevention of attacks in patients with hereditary angioedema Open
Summary Background Long‐term prophylaxis with subcutaneous (SC) administration of a highly concentrated plasma‐derived C1‐esterase inhibitor (C1‐INH) formulation was recently approved by the Food and Drug Administration for hereditary angi…
View article: CSL112 (Apolipoprotein A-I [Human]) Enhances Cholesterol Efflux Similarly in Healthy Individuals and Stable Atherosclerotic Disease Patients
CSL112 (Apolipoprotein A-I [Human]) Enhances Cholesterol Efflux Similarly in Healthy Individuals and Stable Atherosclerotic Disease Patients Open
Objective— CSL112 (apolipoprotein A-I [apoA-I; human]) is a novel formulation of apoA-I in development for reduction of early recurrent cardiovascular events after acute myocardial infarction. Cholesterol efflux capacity (CEC) is a marker …
View article: Pharmacokinetics of Hizentra at Weekly vs. Biweekly Dosing Regimens
Pharmacokinetics of Hizentra at Weekly vs. Biweekly Dosing Regimens Open
View article: Exposure‐Response Model of Subcutaneous C1‐Inhibitor Concentrate to Estimate the Risk of Attacks in Patients With Hereditary Angioedema
Exposure‐Response Model of Subcutaneous C1‐Inhibitor Concentrate to Estimate the Risk of Attacks in Patients With Hereditary Angioedema Open
Subcutaneous C1‐inhibitor (HAEGARDA, CSL Behring), is a US Food and Drug Administration (FDA)‐approved, highly concentrated formulation of a plasma‐derived C1‐esterase inhibitor (C1‐INH), which, in the phase III Clinical Studies for Optima…
View article: P1106Direct augmentation of cholesterol efflux capacity in AMI patients: a PKPD substudy of AEGIS-I
P1106Direct augmentation of cholesterol efflux capacity in AMI patients: a PKPD substudy of AEGIS-I Open
View article: Quantitative disease progression model of α‐1 proteinase inhibitor therapy on computed tomography lung density in patients with α‐1 antitrypsin deficiency
Quantitative disease progression model of α‐1 proteinase inhibitor therapy on computed tomography lung density in patients with α‐1 antitrypsin deficiency Open
Aims Early‐onset emphysema attributed to α‐1 antitrypsin deficiency (AATD) is frequently overlooked and undertreated. RAPID‐RCT/RAPID‐OLE, the largest clinical trials of purified human α‐1 proteinase inhibitor (A 1 ‐PI; 60 mg kg –1 week –1…
View article: Abstracts from the 10th C1-inhibitor deficiency workshop
Abstracts from the 10th C1-inhibitor deficiency workshop Open
View article: Population pharmacokinetics of recombinant coagulation factor VIII‐SingleChain in patients with severe hemophilia A
Population pharmacokinetics of recombinant coagulation factor VIII‐SingleChain in patients with severe hemophilia A Open
View article: Intravenous Immunoglobulin (Privigen®) Has Similar Pharmacokinetic Properties in Primary and Secondary Immunodeficiency
Intravenous Immunoglobulin (Privigen®) Has Similar Pharmacokinetic Properties in Primary and Secondary Immunodeficiency Open
View article: Similar Efficacy and Pharmacokinetic Behavior of Intravenous Immunoglobulin (Privigen®) in Primary and Secondary Immunodeficiency
Similar Efficacy and Pharmacokinetic Behavior of Intravenous Immunoglobulin (Privigen®) in Primary and Secondary Immunodeficiency Open
View article: Long-term efficacy and safety of α1 proteinase inhibitor treatment for emphysema caused by severe α1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE)
Long-term efficacy and safety of α1 proteinase inhibitor treatment for emphysema caused by severe α1 antitrypsin deficiency: an open-label extension trial (RAPID-OLE) Open
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Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients
Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients Open
Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus.
View article: Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus
Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus Open
This prospective, randomized, double-blind, placebo-controlled study evaluated the effects of ramipril on urinary protein excretion in renal transplant patients treated with sirolimus following conversion from a calcineurin inhibitor. Pati…