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Volumn 34, Issue 1 SPEC. ISS., 2006, Pages 65-68
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Regulatory perspectives from Japan - Comparability of biopharmaceuticals
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Author keywords
Biotechnological product; Comparability; Harmonization; ICH guideline; Japan; Regulatory perspectives
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Indexed keywords
BIOLOGICAL PRODUCT;
GENERIC DRUG;
RECOMBINANT HUMAN INSULIN;
RECOMBINANT PROTEIN;
BIOEQUIVALENCE;
BIOTECHNOLOGICAL PRODUCTION;
COMPARATIVE STUDY;
DRUG APPROVAL;
DRUG CONTAMINATION;
DRUG EFFICACY;
DRUG IMPURITY;
DRUG MANUFACTURE;
DRUG POTENCY;
DRUG PURITY;
DRUG QUALITY;
DRUG SAFETY;
DRUG STABILITY;
INTERNATIONAL COOPERATION;
JAPAN;
LICENSING;
PHARMACEUTICAL ENGINEERING;
PHYSICAL CHEMISTRY;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
PROCESS DEVELOPMENT;
RECOMBINANT DNA TECHNOLOGY;
REVIEW;
VALIDATION STUDY;
VALIDITY;
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EID: 33644501793
PISSN: 10451056
EISSN: 10958320
Source Type: Journal
DOI: 10.1016/j.biologicals.2005.08.017 Document Type: Article |
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Times cited : (5)
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References (0)
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