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Biological, Medical, and Clinical Analysis
Biopharmaceutical Perspectives
Biopharmaceuticals and Protein Analysis
Cannabis Analysis
Capillary Electrophoresis
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ChromAcademy
Corporate Profiles
Data Acquisition, Handling, and Archiving
Data Analysis, Statistics, and Chemometrics
Dietary Supplements Analysis
Environmental Analysis
Field-Flow Fractionation (FFF)
Food and Beverage Analysis
Forensics, Narcotics
From the Editor
GC–MS
Gas Chromatography (GC)
HILIC
HPLC
Ion Chromatography
LCGC Interviews
LCGC TV: Gas Chromatography
LCGC TV: Hyphenated Techniques
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LCGC TV: Sample Preparation
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Liquid Chromatography (LC/HPLC)
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Medical/Biological
Multidimensional GC
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Peer-Reviewed Articles
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Preparative-Scale Chromatography
Process Analytical Technology (PAT)
Quality Control/Quality Assurance (QA/QC)
Quality by Design (QbD)
Regulatory Standards, GLP and GMP Compliance
Sample Preparation
Size-Exclusion Chromatography (SEC)
Solid-Phase Extraction (SPE)
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M. Caphart

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Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

E. Leutzinger;R. Frankewich;P. Faustino;R. Rajagopalan;Y. Chiu;L. Ng;R. Brown;J. Gibbs;E. Sheinin;G. Lunn;M. Caphart
January 1st 2001

The FDA recently updated its 1987 guidelines for submitting samples and analytical data for method validation — a document that affects all analytical chemists working in the pharmacrutical industry. This article highlights the agency's recommendations of how to report and validate analytical data in all new drug applications.

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