Shailly Mehrotra
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View article: Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor
Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor Open
Zasocitinib (TAK-279) is an investigational, oral, highly selective, and potent allosteric TYK2 inhibitor. This study assessed the TYK2 inhibitory selectivity and potency of zasocitinib versus those of licensed TYK2 and Jak inhibitors. Bin…
View article: Population pharmacokinetic modeling of vedolizumab for graft‐versus‐host disease prophylaxis in adults with allogeneic hematopoietic stem cell transplant
Population pharmacokinetic modeling of vedolizumab for graft‐versus‐host disease prophylaxis in adults with allogeneic hematopoietic stem cell transplant Open
We aimed to characterize the population pharmacokinetics (PK) of vedolizumab for acute graft‐versus‐host disease prophylaxis in adults undergoing allogeneic hematopoietic stem cell transplantation (allo‐HSCT) and assess potential clinicall…
View article: ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse
ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse Open
gov: NCT03029143.
View article: Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK‐906) for idiopathic or diabetic gastroparesis
Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK‐906) for idiopathic or diabetic gastroparesis Open
Background Previous clinical studies of trazpiroben, a dopamine D 2 /D 3 receptor antagonist for long‐term treatment of moderate‐to‐severe idiopathic and diabetic gastroparesis, have shown improved symptoms of fullness. This study assessed…
View article: Supplemental Figure Legends and Tables from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure Legends and Tables from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
7 tables and 3 figure legends
View article: Supplemental Figure 1B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 1B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between AUC and Cmax at steady state (B
View article: Supplemental Figure 1A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 1A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between AUC and Cmax after single dose (A)
View article: Supplemental Figure 1A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 1A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between AUC and Cmax after single dose (A)
View article: Data from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Data from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Purpose: A phase I trial of veliparib in combination with topotecan plus carboplatin (T+C) demonstrated a 33% objective response rate in patients with hematological malignancies. The objective is to perform exposure–response analysis to in…
View article: Supplemental Figure 3A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 3A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between veliparib exposure-% CFB in PAR levels in PBMC (A) and �B in PAR levels-ORR (B)
View article: Supplemental Figure 2 from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 2 from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Correlation between objective response rate (ORR) and overall survival (OS)
View article: Supplemental Figure 2 from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 2 from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Correlation between objective response rate (ORR) and overall survival (OS)
View article: Supplemental Figure 3A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 3A from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between veliparib exposure-% CFB in PAR levels in PBMC (A) and �B in PAR levels-ORR (B)
View article: Supplemental Figure 1B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 1B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between AUC and Cmax at steady state (B
View article: Supplemental Figure 3B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 3B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between veliparib exposure-% CFB in PAR levels in PBMC (A) and �B in PAR levels-ORR (B)
View article: Data from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Data from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Purpose: A phase I trial of veliparib in combination with topotecan plus carboplatin (T+C) demonstrated a 33% objective response rate in patients with hematological malignancies. The objective is to perform exposure–response analysis to in…
View article: Supplemental Figure 3B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure 3B from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Relationship between veliparib exposure-% CFB in PAR levels in PBMC (A) and �B in PAR levels-ORR (B)
View article: Supplemental Figure Legends and Tables from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Supplemental Figure Legends and Tables from Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
7 tables and 3 figure legends
View article: Neurotransmitter transporter occupancy following administration of centanafadine sustained-release tablets: A phase 1 study in healthy male adults
Neurotransmitter transporter occupancy following administration of centanafadine sustained-release tablets: A phase 1 study in healthy male adults Open
Background: Centanafadine is an inhibitor of reuptake transporters for norepinephrine (NET), dopamine (DAT) and serotonin (SERT). Aims: This phase 1, adaptive-design positron emission tomography study investigated the occupancy time course…
View article: Issue Information
Issue Information Open
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: Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder
Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder Open
Evening-dosed HLD200 produces the intended DR and ER pharmacokinetic profile that provides a consistent predictable delay in initial MPH release until the early morning, followed by extended release across the day. The body weight-adjusted…
View article: Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies
Exposure–Response of Veliparib to Inform Phase II Trial Design in Refractory or Relapsed Patients with Hematological Malignancies Open
Purpose: A phase I trial of veliparib in combination with topotecan plus carboplatin (T+C) demonstrated a 33% objective response rate in patients with hematological malignancies. The objective is to perform exposure–response analysis to in…
View article: Parent‐Metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT‐888), a PARP Inhibitor, in Patients With <i>BRCA 1/2</i>–Mutated Cancer or PARP‐Sensitive Tumor Types
Parent‐Metabolite Pharmacokinetic Modeling and Pharmacodynamics of Veliparib (ABT‐888), a PARP Inhibitor, in Patients With <i>BRCA 1/2</i>–Mutated Cancer or PARP‐Sensitive Tumor Types Open
Veliparib (ABT‐888) is a novel oral poly‐ADP‐ribose polymerase (PARP) inhibitor that is being developed for the treatment of hematologic malignancies and solid tumors. Although the pharmacokinetics of veliparib have been studied in combina…
View article: Population pharmacokinetics and site of action exposures of veliparib with topotecan plus carboplatin in patients with haematological malignancies
Population pharmacokinetics and site of action exposures of veliparib with topotecan plus carboplatin in patients with haematological malignancies Open
Aims Veliparib is a potent inhibitor of poly(ADP‐ribose) polymerase (PARP) enzyme. The objectives of the analysis were to evaluate the effect of baseline covariates and co‐administration of topotecan plus carboplatin (T + C) on pharmacokin…
View article: Ceftolozane-Tazobactam Pharmacokinetics in a Critically Ill Patient on Continuous Venovenous Hemofiltration
Ceftolozane-Tazobactam Pharmacokinetics in a Critically Ill Patient on Continuous Venovenous Hemofiltration Open
Extended-infusion ceftolozane-tazobactam treatment at 1.5 g every 8 h was used to treat multidrug-resistant Pseudomonas aeruginosa in a critically ill patient on continuous venovenous hemofiltration. Serum drug concentrations were measured…