Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients

Drug Information Journal

Volumn 46, Issue 5, 2012, Pages 611-626

  Capaldi, Daniel ^a   Ackley, Kathy ^b   Brooks, Doug ^c   Carmody, Judy ^d   Draper, Ken ^e   Kambhampati, Rao ^f   Kretschmer, Matthias ^g   Levin, Daren ^h   McArdle, James ⁱ   Noll, Bernhard ^j   Raghavachari, Ramesh ^f   Roymoulik, Ipsita ^k   Sharma, B P ^l   Thürmer, René ^m   Wincott, Fran ⁿ  

^a ISIS PHARMACEUTICALS   (United States)

^b Girindus America Inc   (United States)

^c Regado Biosciences   (United States)

^d Ziopharm Oncology Inc   (United States)

^e International Scientific Associates LLC   (United States)

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

^g ALNYLAM PHARMACEUTICALS   (United States)

^h GLAXOSMITHKLINE   (United States)

ⁱ McArdle and Associates   (United States)

^j NBChemde   (Germany)

^k NITTO DENKO Avecia   (United States)

^l GERON CORPORATION   (United States)

^m BfArM   (Germany)

ⁿ Wincott and Associates LLC   (United States)

more..

Author keywords

active pharmaceutical ingredients; analytical methods; specification tests; specifications; therapeutic oligonucleotides

Indexed keywords

DOUBLE STRANDED OLIGONUCLEOTIDE; ENDOTOXIN; HEAVY METAL; OLIGONUCLEOTIDE; SINGLE STRANDED OLIGONUCLEOTIDE; SOLVENT; UNCLASSIFIED DRUG;

ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; ATOMIC ABSORPTION SPECTROMETRY; DRUG ANALYSIS; DRUG CONFORMATION; DRUG CONJUGATION; DRUG DEVELOPMENT; DRUG MANUFACTURE; ELECTROSPRAY MASS SPECTROMETRY; GAS CHROMATOGRAPHY; GEL ELECTROPHORESIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULE; PRACTICE GUIDELINE; PRIORITY JOURNAL; WATER CONTENT;

EID: 84873801436     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/0092861512445311     Document Type: Article

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