Regulatory considerations for peptide drug products

Regulatory Considerations for Peptide Drug Products

Regulatory Considerations for Peptide Drug Products Larisa C. Wu Peptide Team OGD/CDER/FDA 2013 GPhA/FDA CMC Workshop June 5, 2013 This presentation reflects the views of the author and

  Product, Drug, Regulatory, Considerations, Peptides, Regulatory considerations for peptide drug products

FDA perspectives: Biosimilar Development with a …

Steven Kozlowski, M.D. Director, Office of Biotechnology Products OPS/CDER / U.S. FDA FDA/PQRI Conference on Evolving Quality North Bethesda, MD

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M7 (R1) Step 5 Assessment and control of DNA …

ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

Is HPAPI also a Low PDE? - Remedy Publications

AF needs to be applied to address uncertainties associated with estimating a human equivalent dose from a NOAEL (or LOAEL) derived from animal studies.