PISBN：9780081028247
出版社：Elsevier
出版类型：Book
出版时间：2020
作者：Riley,Christopher M.
主题词：Amorphous,Analytical Method Development,Api,Assay,Automation,Chiral Column Screen,Chirality,Chromatography,Circular Dichroism,Class Of Residual Solvent,Classification Of Residual Solvents,Compendial Method,Controlled Extraction,Critical Quality Attributes,Crystalline,Design Of Experiments (Doe),Dissolution,Drug Product,Drug Release,Drug Substance,Electrophoresis,Elemental Impurities,Enantiomer,Excipient,Extractables,Gas Chromatography (Gc),Genotoxic Impurities,Guidance,Ich Q2,Ich Q3C,Icms,Identification,Impurities,Impurity Identification,Impurity Qualification,Inductively Coupled Plasma,Karl Fischer Titration (Kft),Leachables,Lead,Limit Test,Loss On Drying (Lod),Method Development,Method Errors,Method Transfer,Method Validation,Modeling,Neainfrared Spectroscopy (Nirs),Permitted Daily Exposure,Phase Appropriate Validation,Polarimetry,Polymorph,Precision,Process Capability Indices,Proof Of Concept,Quality By Design(Qbd),Quantitation,Remediation,Residual Solvent,Residual Solvents In Excipients,Revalidation,Robustness,Simulated Use Extraction,Solid Form,Solistate Characterization,Specifications,Stereoisomer,System Suitability,Validation,Validation Parameters,Verification,Water Determination,Inhalation Products, Acceptance Criteria,Accuracy,Amorphous,Amt,Analytical,Analytical Method Development,Analytical Method Development Strategies,Analytical Methods Transfer,Analytical Quality By Design (Aqbd),Analytical Target Profile,Analytical Target Profile,Api,Apparatus,Assay,Basket,Bioanalysis,Bioequivalence,Biological Matrix,Biomarker,Biotechnology Products,Chiral Column Screen,Chirality,Chromatography,Circular,Cmc Development,Compendial Method,Continuous Improvement,Continuous Manufacturing,Control Strategies,Controlled Extraction,Critical Quality Attributes,Crystalline,Degradation Products,Description,Design Of Experiments,Design Of Experiments (Doe),Design Space,Detection Limit,Diffusion,Discriminatory,Dissolution,Doe,Dosage Forms,Dose Discrimination,Drug Product,Drug Release,Drug Substance,Ds And Dp Controls,Dwell Volume Effects,Electrophoresis,Elemental,Enantiomer,Excipient,Extractables,, Specification Of Drug Substances And Products, Development And Validation Of Analytical Methods
学科：R9 药学
语种：英语
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