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Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products

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Abstract

The emergence of quality by design as a relatively new systematic science and risk-based approach has added a new dimension to pharmaceutical development and manufacturing. This review attempts to discuss the quality by design elements and concepts applied for topical semisolid products. Quality by design begins with defining a quality target product profile as well as critical quality attributes. Subsequently, this is followed by risk identification/risk analysis/risk evaluation to recognize critical material attributes and critical process parameters, in conjunction with design of experiments or other appropriate methods to establish control strategies for the drug product. Several design-of-experiment examples are included as practical strategies for the development and optimization of formulation and process for topical drug products.

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Fig. 1
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Abbreviations

Q1:

Same components as the reference-listed drug

Q2:

Same components in same concentration as the reference-listed drug

Q3:

Same components in same concentration with the same arrangement of matter (microstructure) as the reference-listed drug

RLD:

Reference-listed drug

QbD:

Quality by design

QbT:

Quality by testing

CMA:

Critical material attribute

CPP:

Critical process parameter

DoE:

Design of experiments

QTPP:

Quality target product profile

CQA:

Critical quality attribute

FMECA:

Failure mode effects criticality analysis

FMEA:

Failure mode effects analysis

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Acknowledgments

The authors thank Drs. Daniel Peng and Yue Teng for their constructive comments during the preparation of the manuscript.

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Authors and Affiliations

  1. Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, Maryland, 20855, USA

    Rong-Kun Chang, Andre Raw, Robert Lionberger & Lawrence Yu

Authors
  1. Rong-Kun Chang
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  2. Andre Raw
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  3. Robert Lionberger
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  4. Lawrence Yu
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Corresponding author

Correspondence to Rong-Kun Chang.

Additional information

The opinions expressed in this review by the authors do not necessarily reflect the views or policies of the Food and Drug Administration (FDA).

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Chang, RK., Raw, A., Lionberger, R. et al. Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products. AAPS J 15, 674–683 (2013). https://doi.org/10.1208/s12248-013-9472-8

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