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Nanopharmaceuticals: Challenges and Regulatory Perspective

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Book cover Nanotechnology in Drug Delivery

Part of the book series: Biotechnology: Pharmaceutical Aspects ((PHARMASP,volume X))

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Notes

  1. 1.

    Disclaimer: The opinions expressed in this chapter are only of authors and do not necessarily reflect the policy and statements of the FDA.

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Author information

Authors and Affiliations

  1. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver spring, MD 20993, USA

    Rakhi B. Shah

  2. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver spring, MD 20993, USA

    Mansoor A. Khan

Authors
  1. Rakhi B. Shah
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Editor information

Editors and Affiliations

  1. University of Wisconsin, Madison, WI, USA

    Melgardt M. de Villiers  & Glen S. Kwon  & 

  2. Chulalongkorn University, Bangkok, Thailand

    Pornanong Aramwit

Acronyms

ADME

Absorption, distribution, metabolism, and elimination

AFM

Atomic force microscopy

ANDA

Abbreviated New Drug Application

ANF

Asia Nano Forum

ASTM

American Standards for Testing and Materials

API

Active pharmaceutical ingredient

BCS

Biopharmaceutical Classification System

BLA

Biological Licensing Application

CBER

Center for Biological Evaluations and Research

CDER

Center for Drug Evaluation and Research

CDRH

Center for Device and Radiological Health

CFR

Code of Federal Registrar

CMC

Chemistry, manufacturing, and control

CRN

Center for Responsible Nanotechnology

CST

Council for Science and Technology (United Kingdom)

CTA

Center for Technology Assessment

CVM

Center for Veterinary Medicine

DNA

Deoxyribonucleic acid

EPA

Environmental Protection Agency

FDA

Food and Drug Administration

FD&C act

Food, Drug and Cosmetic Act

FoE

Friends of Earth

GRAS

Generally regarded as safe

ICH

International Conference on Harmonization

ICON

International Council on Nanotechnology

ICTA

International Center for Technology Assessment

IIG

Inactive Ingredient Guide

IV

Intravenous

MHRA

Medicines and Healthcare Products Regulatory Agency (United Kingdom)

MRI

Magnetic resonance imaging

NCL

National Characterization Laboratory

NCI

National Cancer Institute

NDA

New Drug Application

NIST

National Institute of Standards and Technology

NNI

National Nanotechnology Initiative

NSCT

National Strategy for Combating Terrorism

ORA

Office of Regulatory Affairs

OSHC

Office of Science and Health Coordination

PD

Pharmacodynamics

PK

Pharmacokinetics

PAT

Process analytical technology

PSD

Particle size distributionh

QbD

Quality by Design

R&D

Research and Development

SC

Subcutaneous

SEDDS

Self-emulsifying drug delivery systems

SNEDDS

Self-nano-emulsifying drug delivery systems

USC

United States Code

UV

Ultraviolet

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© 2009 American Association of Pharmaceutical Scientists

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Shah, R.B., Khan, M.A. (2009). Nanopharmaceuticals: Challenges and Regulatory Perspective. In: de Villiers, M.M., Aramwit, P., Kwon, G.S. (eds) Nanotechnology in Drug Delivery. Biotechnology: Pharmaceutical Aspects, vol X. Springer, New York, NY. https://doi.org/10.1007/978-0-387-77668-2_21

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