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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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).
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Pharmacogenomics: Identification of New Drug Targets01:29

Pharmacogenomics: Identification of New Drug Targets

Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Therapy01:28

Drug Therapy

The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications

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Related Experiment Video

Updated: May 14, 2026

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

Pixantrone: merging safety with efficacy.

Dionysios Papadatos-Pastos1, Ruth Pettengell

  • 1St George's Healthcare NHS Trust, London, UK.

Expert Review of Hematology
|February 5, 2013
PubMed
Summary

Pixantrone, a novel anthracycline derivative, offers anticancer efficacy with reduced cardiotoxicity. It is now approved for refractory non-Hodgkin lymphomas, with ongoing trials exploring combination therapies.

Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • Anthracyclines are effective chemotherapy agents but are limited by cardiotoxicity.
  • Pixantrone was developed as a novel anthracycline derivative to mitigate cardiotoxicity while preserving anticancer activity.

Purpose of the Study:

  • To evaluate the efficacy and safety of pixantrone in cancer treatment.
  • To assess pixantrone's potential as a less cardiotoxic alternative to traditional anthracyclines.

Main Methods:

  • Initial safety and Phase II trials were conducted.
  • Multicenter, randomized clinical trials were performed using pixantrone as a single agent or in combination therapy.
  • European Medicines Agency (EMA) approval was sought based on PIX301 trial results.

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Intracameral Injection in Rats with Low Risk of Adverse Effects
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Intracameral Injection in Rats with Low Risk of Adverse Effects

Published on: May 31, 2024

Related Experiment Videos

Last Updated: May 14, 2026

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

Intracameral Injection in Rats with Low Risk of Adverse Effects
06:19

Intracameral Injection in Rats with Low Risk of Adverse Effects

Published on: May 31, 2024

Main Results:

  • Preliminary evidence indicated anticancer activity and manageable toxicity for pixantrone.
  • Clinical trials validated these findings, supporting its therapeutic potential.
  • Pixantrone demonstrated efficacy in pretreated patients with refractory non-Hodgkin lymphomas.

Conclusions:

  • Pixantrone is an approved monotherapy for refractory non-Hodgkin lymphomas.
  • Ongoing research is investigating pixantrone in combination regimens for expanded therapeutic applications.