Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks

AAPS Journal

Volumn 17, Issue 1, 2015, Pages 44-64

  Bartlett, Jeremy A ^a   Brewster, Marcus ^b   Brown, Paul ^c   Cabral Lilly, Donna ^d   Cruz, Celia N ^c   David, Raymond ^e   Eickhoff, W Mark ^f   Haubenreisser, Sabine ^g   Jacobs, Abigail ^c   Malinoski, Frank ^h   Morefield, Elaine ⁱ   Nalubola, Ritu ^c   Prud’homme, Robert K ^j   Sadrieh, Nakissa ^c   Sayes, Christie M ^k   Shahbazian, Hripsime ^l   Subbarao, Nanda ^m   Tamarkin, Lawrence ⁿ   Tyner, Katherine ^c   Uppoor, Rajendra ^c   Whittaker Caulk, Margaret ^c   Zamboni, William ^o,p   more..

^a PFIZER INC   (United States)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d a subsidiary of Jazz Pharmaceuticals   (United States)

^e BASF CORPORATION   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

^g EUROPEAN MEDICINES AGENCY   (United Kingdom)

^h Nanomedicines Alliance   (United States)

ⁱ VERTEX PHARMACEUTICALS   (United States)

^j Princeton University   (United States)

^k RTI INTERNATIONAL   (United States)

^l HEALTH CANADA   (Canada)

^m Biologics Consulting Group   (United States)

ⁿ CytImmune Sciences Inc   (United States)

^o UNC Hamner Institute for Drug Safety Sciences   (United States)

^p Pharmaceutical Development Center   (United States)

more..

Author keywords

nanomaterials; nanomedicine; nanotechnology; PQRI; risk management; USFDA

Indexed keywords

ANTINEOPLASTIC AGENT; COLLOIDAL GOLD; DRUG; EXCIPIENT; GOLD NANOPARTICLE; LIPOSOME; NANOMATERIAL; NANOPARTICLE;

AREA UNDER THE CURVE; ARTICLE; DRUG APPROVAL; DRUG CLEARANCE; DRUG EFFICACY; DRUG FORMULATION; DRUG IMPURITY; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; GOVERNMENT REGULATION; NANOEMULSION; NANOMEDICINE; PATENT; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; QUALITY CONTROL; RISK ASSESSMENT; RISK MANAGEMENT; SHELF LIFE; SUSPENSION; ANIMAL; CHEMISTRY; DRUG CONTROL; DRUG DESIGN; HUMAN; MEDICINAL CHEMISTRY; TISSUE DISTRIBUTION;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG DESIGN; HUMANS; NANOPARTICLES; NANOSTRUCTURES; PHARMACEUTICAL PREPARATIONS; TISSUE DISTRIBUTION;

EID: 84922105868     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9701-9     Document Type: Article

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