Nanomedicines: Addressing the scientific and regulatory gap

Sally Tinkle, Scott E. McNeil, Stefan Mühlebach, Raj Bawa*, Gerrit Borchard, Yechezkel Barenholz, Lawrence Tamarkin, Neil Desai

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

1 Scopus citations
Original languageEnglish
Title of host publicationHandbook of Clinical Nanomedicine
Subtitle of host publicationLaw, Business, Regulation, Safety, and Risk
PublisherPan Stanford Publishing Pte. Ltd.
Pages413-470
Number of pages58
Volume2
ISBN (Electronic)9789814669238
ISBN (Print)9789814669221
DOIs
StatePublished - 2 May 2016

Keywords

  • Abbreviated new drug application (anda)
  • Abraxane®
  • Bayh-dole act
  • Bioequivalence
  • Biosimilars
  • Commercialization
  • Doxil®
  • European medicines agency (ema)
  • Fda regulation
  • Follow-on biologics
  • Food and drug administration (fda)
  • Immunogenicity
  • Invention
  • Monoclonal antibodies (mabs)
  • Nanomedicine
  • Nanopharmaceuticals
  • Nanosimilars
  • Nanotechnology
  • Nanotechnology characterization laboratory (ncl)
  • New drug application (nda)
  • Non-biologic complex drug (nbcd)
  • Patent classification
  • Patent laws
  • Patent thickets
  • Patents
  • Pharmacodynamics
  • Pharmacokinetics
  • Post-blockbuster world
  • Regulation
  • Us patent & Trademark office (pto)

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