For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

Analytical science

Why one analytical method is not the whole picture

The logic of orthogonal techniques and measuring different critical attributes.

The logic of orthogonal techniques and measuring different critical attributes.

Every method has a scope

A method is designed for a particular analytical attribute and reportable range. Selectivity adequate for one question may not be adequate for another. Sound evaluation starts with purpose, not with how advanced the instrument sounds.

Orthogonal evidence

Two techniques are usefully orthogonal when they rely on different physicochemical principles. Agreement can increase confidence, while disagreement can reveal interference or a faulty assumption. The second method should add information, not merely another graph.

A risk-based strategy

Test selection should connect to attributes critical for the research purpose and to the risk of a wrong conclusion. Documentation explains why each method was selected and what uncertainty remains after measurement.

Sources and further reading

  1. ICH Q2(R2) — Validation of Analytical Procedures
  2. EMA / ICH Q14 — Analytical procedure development
RESEARCH-USE BOUNDARY

For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

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