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Drug Development and Industrial Pharmacy Volume 26, 2000 - Issue 11
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Research Article

RSD Requirement for Different Sample Size for Blend Sampling

Hewa Saranadasa
Pages 1213-1216 | Published online: 31 Oct 2000

REFERENCES

  • Guidance for Industry. ANDAs: Blend Uniformity Analysis. U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER), Office of Generic Drugs, Washington, DC August 1999
  • Dietrick J. M. Food and drug administration recommendations on validation issues. Reg. Affairs 1993; 5: 363–366

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