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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists01:18

Treatment for Pulmonary Arterial Hypertension: Endothelin Receptor Antagonists

Endothelins (ETs) are potent vasoactive peptides critical in the human body's various physiological and pathological processes. One of the most promising therapeutic strategies for treating pulmonary arterial hypertension (PAH) involves counteracting the effects of these endothelins using a class of drugs known as endothelin receptor antagonists.
ETs are synthesized through a complex sequence of enzymatic steps, primarily involving an enzyme referred to as endothelin-converting enzyme (ECE). Of...
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...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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...
Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers01:26

Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers

Receptor tyrosine kinase inhibitors (TKIs) and calcium channel blockers (CCBs) are two critical categories of drugs employed in the treatment of pulmonary artery hypertension (PAH). PAH is a disease that causes high blood pressure in the pulmonary arteries, resulting in chest pain, fatigue, and shortness of breath.
TKIs, such as imatinib (Gleevec), are particularly effective in tackling the growth and mitogenic factors that become upregulated in PAH patients. These factors contribute to the...

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Related Experiment Video

Updated: May 30, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

Vandetanib: first global approval.

Helen Commander1, Glenn Whiteside, Caroline Perry

  • 1RD Insight, Wolters Kluwer Pharma Solutions, Auckland, New Zealand.

Drugs
|July 21, 2011
PubMed
Summary

Vandetanib is approved for metastatic medullary thyroid cancer (MTC). This oral therapy targets key receptors like vascular endothelial growth factor receptor-2 (VEGFR-2) and epidermal growth factor receptor (EGFR).

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Medullary thyroid cancer (MTC) is a rare endocrine malignancy.
  • Targeted therapies offer new treatment avenues for advanced MTC.
  • Vandetanib targets multiple key signaling pathways implicated in MTC growth.

Purpose of the Study:

  • To summarize the development milestones of vandetanib.
  • To highlight the regulatory approval process for vandetanib in MTC.
  • To provide an overview of vandetanib's mechanism of action.

Main Methods:

  • Review of regulatory filings and clinical development data.
  • Analysis of vandetanib's pharmacological profile.
  • Summary of pivotal trials leading to approval.

Related Experiment Videos

Last Updated: May 30, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

Main Results:

  • Vandetanib is an orally active antagonist of VEGFR-2, EGFR, and RET kinase.
  • Vandetanib received US approval for metastatic MTC.
  • Regulatory submissions are underway in the EU and Canada.

Conclusions:

  • Vandetanib represents a significant advancement in MTC treatment.
  • The drug's multi-targeted approach addresses critical oncogenic pathways.
  • Further development is ongoing for other cancer types.