Quality specifications for peptide drugs: A regulatory-pharmaceutical approach

Journal of Peptide Science

Volumn 15, Issue 11, 2009, Pages 697-710

  Vergote, Valentijn ^a   Burvenich, Christian ^a   Van De Wiele, Christophe ^b   De Spiegeleer, Bart ^a  

^a GHENT UNIVERSITY   (Belgium)

^b GHENT UNIVERSITY   (Belgium)

Author keywords

Acceptance criteria; ICH guidelines; Peptide drug substance; Ph. Eur. And USP pharmacopoeial monographs; Quality attributes; Regulatory affairs; Related substances thresholds

Indexed keywords

ACETIC ACID; AMINO ACID; BACITRACIN ZINC; BOVINE INSULIN; BUSERELIN; BUSERELIN ACETATE; COLISTIMETHATE; DESMOPRESSIN ACETATE; FELYPRESSIN; GLUCAGON; GONADORELIN; GONADORELIN ACETATE; GOSERELIN; GRAMICIDIN; HUMAN INSULIN; INSULIN ASPART; INSULIN LISPRO; LEUPRORELIN; OXYTOCIN; PEPTIDE DERIVATIVE; PIG INSULIN; POLYMYXIN B; PROTEIN; PROTIRELIN; SALCATONIN; SOMATOSTATIN; TETRACOSACTIDE; TYROTHRICIN; UNINDEXED DRUG; VASOPRESSIN;

AMINO ACID ANALYSIS; ANALYTIC METHOD; CARBON NUCLEAR MAGNETIC RESONANCE; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG PURITY; DRUG SAFETY; DRUG STRUCTURE; DRUG SYNTHESIS; INFRARED SPECTROPHOTOMETRY; LIQUID CHROMATOGRAPHY; MEDICAL LITERATURE; MOLECULAR WEIGHT; PEPTIDE SYNTHESIS; PRIORITY JOURNAL; PROTON NUCLEAR MAGNETIC RESONANCE; QUALITY CONTROL; REVIEW; THIN LAYER CHROMATOGRAPHY;

PEPTIDES; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS AS TOPIC; QUALITY CONTROL;

EID: 70449629848     PISSN: 10752617     EISSN: 10991387     Source Type: Journal    
DOI: 10.1002/psc.1167     Document Type: Review

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