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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Question-based review for pharmaceutical development: An enhanced quality approach.

Ana Simões1, Francisco Veiga1, Carla Vitorino2

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Summary
This summary is machine-generated.

Quality by Design (QbD) offers a systematic approach to pharmaceutical development, enhancing drug quality and efficiency. Despite its benefits, full implementation faces challenges, necessitating further harmonization in regulatory submissions.

Keywords:
Control strategyCritical material attributesCritical process parametersCritical quality attributesDesign of experimentsDesign spaceMathematical modelingQuality by designQuality target product profileRisk assessment

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Science
  • Drug Development

Background:

  • The pharmaceutical industry faces quality assurance challenges, driving the need for holistic development approaches.
  • Quality by Design (QbD) is a systematic, risk-based methodology enhancing drug safety, efficacy, and quality.
  • QbD offers benefits like time/cost savings, R&D streamlining, manufacturing flexibility, and reduced regulatory burden.

Purpose of the Study:

  • To provide a comprehensive overview of the current application status of QbD principles.
  • To analyze the harmonization of QbD information in Marketing Authorization Applications (MAAs) for European market approval.
  • To identify challenges hindering the widespread adoption of QbD as a standard pharmaceutical practice.

Main Methods:

  • Review of current QbD implementation status within ICH Q8(R2)-Q14 and ICH Q2(R2) guidelines.
  • Analysis of how QbD-generated data is harmonized in MAAs for European regulatory submissions.
  • Identification and discussion of barriers to QbD strategy deployment.

Main Results:

  • QbD principles are established, but full implementation in the pharmaceutical field remains limited.
  • Information harmonization from QbD in MAAs is evolving for European market approval.
  • Several challenges impede the routine use of QbD in pharmaceutical development.

Conclusions:

  • QbD offers significant advantages for pharmaceutical development and quality assurance.
  • Further efforts are needed to overcome implementation barriers and standardize QbD practices.
  • Harmonizing QbD data in regulatory submissions is crucial for its successful integration.