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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,...
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To achieve precise distance measurements, especially in surveying and construction, certain corrections must be applied to account for potential sources of error like the standardization errors, temperature variations, and slope adjustments.Standardization error emerges when measurement equipment undergoes changes, such as wear, repairs, or weather impacts. To address this, surveyors compare the equipment’s readings to a standard. This process identifies any deviation that might lead to...
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Correction to: Ivosidenib: First Global Approval.

Sohita Dhillon1

  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|January 6, 2019
PubMed
Summary

Ivosidenib has received its first global approval, marking a significant advancement in targeted cancer therapy. This milestone offers new hope for patients with specific genetic mutations driving their disease.

Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • The article discusses the initial global regulatory approval of the drug ivosidenib.
  • This marks a significant milestone in the availability of targeted cancer therapies.

Purpose of the Study:

  • To report the first global approval of ivosidenib.
  • To highlight the significance of this approval for cancer treatment.

Main Methods:

  • The article is a report on a regulatory event.
  • Information is based on the initial publication details and approval status.

Main Results:

  • Ivosidenib has achieved its first worldwide marketing authorization.
  • This approval signifies the drug's availability to patients.

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Conclusions:

  • The first global approval of ivosidenib represents a key step forward in oncology.
  • This advancement provides a new therapeutic option for patients with specific cancer types.