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Specifications

  • Richard K. Burdick
  • David J. LeBlond
  • Lori B. Pfahler
  • Jorge Quiroz
  • Leslie Sidor
  • Kimberly Vukovinsky
  • Lanju Zhang
Chapter
Part of the Statistics for Biology and Health book series (SBH)

Abstract

Setting specifications for drug substances and drug products is a complex process. Many factors must be considered such as patient requirements, clinical and development experience, and global regulatory expectations. The specification setting process starts with determining the critical attributes and parameters of the product and manufacturing process that need to be controlled to ensure a high quality, safe, and efficacious product for the patient. During the development process, risk assessments, prior knowledge, and experimentation should yield which attributes and parameters need to be controlled and the range over which they can vary and still produce a high quality product. The next step is to understand the global regulatory expectations for setting specifications including compendial requirements. There must be an understanding of the markets the product will be sold in since regulatory requirements vary from market to market. International Conference on Harmonization Q6A (1999a) and International Conference on Harmonization Q6B (1999b) represent efforts to harmonize expectations around specification setting. A review of regulatory and compendial expectations will likely add attributes to the list that require specifications. It will also be important to understand which drug product attributes must meet specifications throughout the shelf life of the product.

Keywords

Acceptance limits Blend uniformity Compendial tests Composite assay Dissolution Percentiles Process capability Protein concentration Release and shelf life limits Similarity factor (f2Simulation Three sigma limits Tolerance intervals Uniformity of dosage units 

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Richard K. Burdick
    • 1
  • David J. LeBlond
    • 2
  • Lori B. Pfahler
    • 3
  • Jorge Quiroz
    • 4
  • Leslie Sidor
    • 5
  • Kimberly Vukovinsky
    • 6
  • Lanju Zhang
    • 7
  1. 1.Elion LabsLouisvilleUSA
  2. 2.CMC StatisticsWadsworthUSA
  3. 3.Merck & Co., Inc.TelfordUSA
  4. 4.Merck & Co., Inc.KenilworthUSA
  5. 5.BiogenCambridgeUSA
  6. 6.PfizerOld SaybrookUSA
  7. 7.Nonclinical Statistics, Abbvie Inc.North ChicagoUSA

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