title: Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.
abstract: 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.
authors.affiliation: Pfizer, Groton Laboratories, Groton, Connecticut, 06340, USA.
authors.forename: Jeremy A
authors.initials: JA
authors.lastname: Bartlett
authors.forename: Marcus
authors.initials: M
authors.lastname: Brewster
authors.forename: Paul
authors.initials: P
authors.lastname: Brown
authors.forename: Donna
authors.initials: D
authors.lastname: Cabral-Lilly
authors.forename: Celia N
authors.initials: CN
authors.lastname: Cruz
authors.forename: Raymond
authors.initials: R
authors.lastname: David
authors.forename: W Mark
authors.initials: WM
authors.lastname: Eickhoff
authors.forename: Sabine
authors.initials: S
authors.lastname: Haubenreisser
authors.forename: Abigail
authors.initials: A
authors.lastname: Jacobs
authors.forename: Frank
authors.initials: F
authors.lastname: Malinoski
authors.forename: Elaine
authors.initials: E
authors.lastname: Morefield
authors.forename: Ritu
authors.initials: R
authors.lastname: Nalubola
authors.forename: Robert K
authors.initials: RK
authors.lastname: Prud'homme
authors.forename: Nakissa
authors.initials: N
authors.lastname: Sadrieh
authors.forename: Christie M
authors.initials: CM
authors.lastname: Sayes
authors.forename: Hripsime
authors.initials: H
authors.lastname: Shahbazian
authors.forename: Nanda
authors.initials: N
authors.lastname: Subbarao
authors.forename: Lawrence
authors.initials: L
authors.lastname: Tamarkin
authors.forename: Katherine
authors.initials: K
authors.lastname: Tyner
authors.forename: Rajendra
authors.initials: R
authors.lastname: Uppoor
authors.forename: Margaret
authors.initials: M
authors.lastname: Whittaker-Caulk
authors.forename: William
authors.initials: W
authors.lastname: Zamboni
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D015195:Drug Design; D004335:Drug and Narcotic Control; D006801:Humans; D053758:Nanoparticles; D049329:Nanostructures; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry; D014018:Tissue Distribution
chemical_list: D004364:Pharmaceutical Preparations