TY - JOUR
T1 - Summary Report of PQRI Workshop on Nanomaterial in Drug Products
T2 - Current Experience and Management of Potential Risks
AU - Bartlett, Jeremy A.
AU - Brewster, Marcus
AU - Brown, Paul
AU - Cabral-Lilly, Donna
AU - Cruz, Celia N.
AU - David, Raymond
AU - Eickhoff, W. Mark
AU - Haubenreisser, Sabine
AU - Jacobs, Abigail
AU - Malinoski, Frank
AU - Morefield, Elaine
AU - Nalubola, Ritu
AU - Prud’homme, Robert K.
AU - Sadrieh, Nakissa
AU - Sayes, Christie M.
AU - Shahbazian, Hripsime
AU - Subbarao, Nanda
AU - Tamarkin, Lawrence
AU - Tyner, Katherine
AU - Uppoor, Rajendra
AU - Whittaker-Caulk, Margaret
AU - Zamboni, William
N1 - Publisher Copyright:
© 2014, American Association of Pharmaceutical Scientists.
PY - 2015/1/6
Y1 - 2015/1/6
N2 - At the Product Quality Research Institute (PQRI) Workshop held last January 14–15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.
AB - At the Product Quality Research Institute (PQRI) Workshop held last January 14–15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.
KW - PQRI
KW - USFDA
KW - nanomaterials
KW - nanomedicine
KW - nanotechnology
KW - risk management
UR - http://www.scopus.com/inward/record.url?scp=84922105868&partnerID=8YFLogxK
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U2 - 10.1208/s12248-014-9701-9
DO - 10.1208/s12248-014-9701-9
M3 - Article
C2 - 25421459
AN - SCOPUS:84922105868
SN - 1550-7416
VL - 17
SP - 44
EP - 64
JO - AAPS Journal
JF - AAPS Journal
IS - 1
ER -