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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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Depolarizing blockers are administered through intravenous injection. Succinylcholine is the most common choice of depolarizing blockers in emergency clinical practices. Although they have a rapid onset, they readily diffuse away from the motor end plate into the extracellular fluid. They are metabolized by enzymes such as liver butyrylcholinesterase and plasma pseudocholinesterases. This produces a short duration of action, typically 5-10 minutes long, unlike nondepolarizing blockers, which...
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Updated: May 31, 2026

Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine
10:05

Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine

Published on: July 7, 2016

Plitidepsin has a safe cardiac profile: a comprehensive analysis.

Arturo Soto-Matos1, Sergio Szyldergemajn1, Sonia Extremera1

  • 1Clinical Oncology, Pharma Mar S.A., Colmenar Viejo, Madrid 28770, Spain.

Marine Drugs
|July 13, 2011
PubMed
Summary

Plitidepsin, a marine-derived cancer drug, showed a safe cardiac profile in patients. Most cardiac adverse events (CAEs) were mild, with no fatal outcomes or dose-related patterns observed.

Keywords:
cancercardiac toxicitychemotherapyplitidepsinsingle agent

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Laser-Induced Action Potential-Like Measurements of Cardiomyocytes on Microelectrode Arrays for Increased Predictivity of Safety Pharmacology

Published on: September 13, 2022

Area of Science:

  • Oncology
  • Cardiology
  • Pharmacology

Background:

  • Plitidepsin, a marine-derived cyclic depsipeptide, is under clinical investigation for cancer treatment.
  • Previous studies indicated potential cardiac toxicity with some depsipeptides.
  • Assessing the cardiac safety of plitidepsin is crucial for its clinical development.

Purpose of the Study:

  • To evaluate the incidence and characteristics of cardiac adverse events (CAEs) associated with single-agent plitidepsin in cancer patients.
  • To identify potential risk factors for plitidepsin-related CAEs.
  • To determine the overall cardiac safety profile of plitidepsin.

Main Methods:

  • Retrospective analysis of clinical trial databases for CAEs in patients treated with plitidepsin.
  • Univariate and multivariate logistic regression to explore demographic, clinical, and pharmacological variables.
  • Analysis of electrocardiogram (ECG) data and pharmacokinetic parameters.

Main Results:

  • 8.0% of patients experienced at least one CAE, with 1.9% considered plitidepsin-related; no fatal CAEs occurred.
  • The most common CAEs were rhythm abnormalities (5.4%), primarily atrial fibrillation/flutter (2.6%).
  • Significant associations with CAEs included primary cancer diagnosis (prostate/pancreas), baseline cardiac risk factors, myalgia, low hemoglobin, and hypokalemia.

Conclusions:

  • Single-agent plitidepsin demonstrates a generally safe cardiac risk profile in cancer patients.
  • Cardiac adverse events, when they occur, are typically not severe and not linked to plitidepsin dose or cumulative exposure.
  • Patient-specific factors, rather than drug exposure, appear to be the primary drivers of cardiac risk.