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Related Concept Videos

Development of Analytical Methods01:21

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Using the Analytical Target Profile to Drive the Analytical Method Lifecycle.

Patrick Jackson1, Phil Borman1, Cristiana Campa2

  • 1Product Development and Supply, Medicines Research Centre , GSK , Gunnels Wood Road , Stevenage SG1 2NY , U.K.

Analytical Chemistry
|January 10, 2019
PubMed
Summary
This summary is machine-generated.

The Analytical Target Profile (ATP) prospectively defines analytical procedure requirements for drug quality. It ensures analytical methods meet quality standards throughout the product lifecycle, aiding regulatory flexibility.

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Quality by Design (QbD)

Background:

  • Quality by Design (ICH-Topic Q8) necessitates the Quality Target Product Profile (QTPP) for drug product quality characteristics.
  • The Analytical Target Profile (ATP) is an analogous concept for analytical procedures, prospectively defining measurement requirements.

Purpose of the Study:

  • To introduce and explain the Analytical Target Profile (ATP) concept for analytical procedures.
  • To demonstrate the application of ATP across different pharmaceutical modalities (small molecules, oligonucleotides, vaccines).
  • To highlight how ATP facilitates quality decisions and regulatory flexibility.

Main Methods:

  • Defining ATP based on maximum uncertainty required for quality decisions.
  • Applying ATP to assess analytical procedure fitness during development and lifecycle changes.
  • Discussing key performance characteristics (specificity, accuracy, precision, combined uncertainty) within the ATP framework.

Main Results:

  • ATP provides a framework for defining and assessing analytical procedures based on quality requirements.
  • Examples illustrate ATP application in small molecules, oligonucleotides, and vaccines.
  • ATP focuses on method properties impacting quality decisions, not just method descriptions.

Conclusions:

  • The ATP concept enhances focus on quality-relevant method attributes, moving beyond mere method descriptions.
  • ATP can enable greater regulatory flexibility through established conditions based on performance criteria (ICHQ12).
  • Harmonization of QbD concepts like ATP is anticipated with ICHQ2(R1) revision and ICHQ14 guideline development.