Implications of in-use photostability: Proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: Drug products administered by injection

Journal of Pharmaceutical Sciences

Volumn 102, Issue 11, 2013, Pages 3888-3899

  Baertschi, Steven W ^a   Clapham, David ^b   Foti, Chris ^c   Jansen, Patrick J ^a   Kristensen, Solveig ^d   Reed, Robert A ^e   Templeton, Allen C ^f   Tønnesen, Hanne Hjorth ^d  

^a ELI LILLY AND COMPANY   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

^c PFIZER INC   (United States)

^d UNIVERSITY OF OSLO   (Norway)

^e Celsion   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Chemical stability; Injectables; Photochemistry; Photodegradation; Physical stability; Preformulation; Stability

Indexed keywords

ALTEPLASE; AMPHOTERICIN B; ATENOLOL; AZAPERONE; BEVACIZUMAB; BIPERIDEN; BLEOMYCIN; BUMETANIDE; CARBOPLATIN; CEFEPIME; CEFTAZIDIME; CISPLATIN; CLADRIBINE; CYTARABINE; DACARBAZINE; DANTROLENE; DAUNORUBICIN; DIAZEPAM; DIAZOXIDE; DIGITOXIN; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; FUROSEMIDE; HALOPERIDOL; IOVERSOL; KETAMINE; LINEZOLID; METHOTREXATE; UNINDEXED DRUG;

DRUG FORMULATION; DRUG LABELING; DRUG MANUFACTURE; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; INJECTION; LIGHT ABSORPTION; LIGHT EXPOSURE; LIGHT INTENSITY; NOTE; PHOTOCHEMISTRY; PHOTOSTABILITY; SHELF LIFE;

CHEMICAL STABILITY; INJECTABLES; PHOTOCHEMISTRY; PHOTODEGRADATION; PHYSICAL STABILITY; PREFORMULATION; STABILITY;

DRUG LABELING; DRUG STABILITY; HUMANS; INJECTIONS; PHARMACEUTICAL PREPARATIONS; PHOTOLYSIS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84885862998     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23717     Document Type: Note

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