Ryan L. Crass

Population Pharmacokinetic and Exposure‐Efficacy Analyses of Valbenazine in Patients with Huntington's Disease: Supporting Dose Selection for Chorea Management

Hoa Q. Nguyen, Ryan L. Crass, Sunny Chapel, Han‐Yi Steve Kuan et autres

Abstract Valbenazine improved chorea in individuals with Huntington's disease compared to placebo in a phase 3, placebo‐controlled study (KINECT‐HD). Population pharmacokinetics (PK) and exposure–response (E–R) analyses focused on understanding the PK characteristics of valbenazine and its active metabolite, [+]‐α‐dihydrotetrabenazine ([+]‐α‐HTBZ), and their …

us (code pays fourni par la source)

The pharmacokinetics of antibiotics in patients with obesity: a systematic review and consensus guidelines for dose adjustments

Anne‐Grete Märtson, Katie E. Barber, Ryan L. Crass, Maya Hites et autres

nl, us, be, de, se, at, au (code pays fourni par la source)

Population Pharmacokinetic and Pharmacokinetic/Pharmacodynamic Analyses of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria

Ryan L. Crass, Brandon Smith, Sven Adriaens, Sunny Chapel et autres

Paroxysmal nocturnal hemoglobinuria is a rare blood disorder characterized by life-threatening hemolysis and thrombosis. Complement C5 inhibitor therapy improves symptoms and life prognosis; however, it can result in insufficient hemolysis control, with residual intravascular hemolysis and extravascular hemolysis in some patients. Pegcetacoplan, …

us, se (code pays fourni par la source)

Population Pharmacokinetics of Pegcetacoplan in Patients with Geographic Atrophy or Neovascular Age-related Macular Degeneration

Ryan L. Crass, Komal Prem, Francois Gauderault, Ramiro Ribeiro et autres

Objective To develop a population pharmacokinetic (PK) model to characterize serum pegcetacoplan concentration-time data after intravitreal administration in patients with geographic atrophy (GA) or neovascular age-related macular degeneration (nAMD). Design Pharmacokinetic modeling. Participants Two hundred sixty-one patients with GA or nAMD enrolled …

us (code pays fourni par la source)

Pharmacokinetic/pharmacodynamic analysis of geographic atrophy lesion area in patients receiving pegcetacoplan treatment or sham

Ryan L. Crass, Komal Prem, François Gaudreault, Elizabeth Lusk et autres

Pegcetacoplan is a complement C3/C3b inhibitor indicated for the treatment of geographic atrophy (GA). A population pharmacokinetic (PK)/pharmacodynamic (PD) analysis of pegcetacoplan used GA lesion area measurements from three clinical studies to determine the effect of pegcetacoplan exposure on GA progression. A …

us (code pays fourni par la source)

A Model‐Informed Drug Development Approach Supporting the Approval of an Unstudied Valbenazine Dose for Patients With Tardive Dyskinesia

Hoa Q. Nguyen, Han‐Yi Steve Kuan, Ryan L. Crass, Lauren Quinlan et autres

Abstract Valbenazine is a highly potent and selective inhibitor of synaptic vesicular monoamine transporter 2. The current therapeutic doses of valbenazine for tardive dyskinesia (TD) are 40, 60, or 80 mg capsules, given orally, once daily (QD). While 40 and 80 mg …

us (code pays fourni par la source)

Use of Model-informed Drug Development and Natural History Data to Inform the Development of Iluzanebart in ALSP: A Neurological Rare Disease

François Gaudreault, Jack Cook, Donald G. McLaren, John Mondick et autres

Population Pharmacokinetic and Exposure-Response Analyses of Valbenazine in Patients with Huntington’s Disease Chorea

Hoa Binh Nguyen, Han‐Yi Steve Kuan, Ryan L. Crass, Sunny Chapel et autres

PB2054: EXPOSURE-RESPONSE ANALYSES OF PEGCETACOPLAN IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA

Haili Ping, Brandon Smith, Sven Adriaens, Ryan L. Crass et autres

Topic: 12. Bone marrow failure syndromes incl. PNH - Clinical Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a clonal hematopoietic stem cell disorder associated with bone marrow failure and thrombosis. Pegcetacoplan, a targeted complement protein C3 therapy, is approved for the treatment of …

us (code pays fourni par la source)

PB2053: POPULATION PHARMACOKINETICS OF PEGCETACOPLAN IN HEALTHY SUBJECTS AND PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA

Haili Ping, Ryan L. Crass, Sunny Chapel, Temitayo Ajayi

Topic: 12. Bone marrow failure syndromes incl. PNH - Clinical Background: Pegcetacoplan is a PEGylated peptide that targets complement protein C3 and C3b. Aims: A population pharmacokinetic (PK) analysis was performed to describe the serum concentration-time profile of pegcetacoplan and quantify the …

us (code pays fourni par la source)

Population pharmacokinetics model of apomorphine (sublingual film or subcutaneous injection) in healthy subjects and patients with Parkinson’s disease (updated)

Felix Agbo, Ryan L. Crass, Yu‐Yuan Chiu, Sunny Chapel et autres

us (code pays fourni par la source)

Population pharmacokinetic and exposure-response safety analyses of mecbotamab vedotin (BA3011) in patients with advanced solid tumors.

Guoxiang Shen, Emily Briggs, Ryan L. Crass, Sravan Karumanchi et autres

e15010 Background: Mecbotamab vedotin (BA3011) is antibody-drug conjugate (ADC) consisting of a conditionally active biologic (CAB) anti-AXL humanized (IgG1) monoclonal antibody conjugated to monomethyl auristatin E (MMAE) using a cleavable linker. BA3011 is being developed for the treatment patients with advanced solid …

us (code pays fourni par la source)