Quantitative risk assessment in classification of drugs with identical API content

Journal of Pharmaceutical and Biomedical Analysis

Volumn 98, Issue , 2014, Pages 186-192

  Rodionova, O Ye ^a,b   Balyklova, K S ^a,c   Titova, A V ^a,d   Pomerantsev, A L ^b,e  

^a Stocktaking and Analysis of Circulation of Medical Products   (Russian Federation)

^b SEMENOV INSTITUTE OF CHEMICAL PHYSICS   (Russian Federation)

^c I M SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY   (Russian Federation)

^d PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY   (Russian Federation)

^e Institute of Natural and Technical Systems RAS   (Russian Federation)

Author keywords

Counterfeiting; DD SIMCA; Future variability; Misclassification errors; Near infrared spectrometry

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENT; AMLODIPINE; COUNTERFEIT DRUG; EXCIPIENT; PANCREATIN; PHARMACEUTICAL VEHICLES AND ADDITIVES; UNCLASSIFIED DRUG; DRUG;

ARTICLE; CHEMOMETRIC ANALYSIS; DATA DRIVEN SOFT INDEPENDENT MODELING OF CLASS ANALOGY; DRUG CLASSIFICATION; DRUG MANUFACTURE; NEAR INFRARED SPECTROSCOPY; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; SHELF LIFE; CHEMISTRY; PROCEDURES;

COUNTERFEIT DRUGS; EXCIPIENTS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; SPECTROSCOPY, NEAR-INFRARED;

EID: 84902343297     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2014.05.033     Document Type: Article

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