Analytical Method Development
About Analytical Method Development
The process of demonstrating that analytical processes are suitable for the purpose of evaluating pharmaceuticals, and notably the active pharmaceutical component, is known as analytical method development and validation (API).
Establishing the identification, purity, physical properties, and potency of pharmaceuticals, as well as the drug's bioavailability and stability, is the goal of analytical technique development.
To evaluate certain substance properties against the established acceptability criteria for such qualities, analytical processes are devised.
Why is Analytical Method Development important?
For any drug development effort, the development and validation of analytical methods are crucial.
The success of a pharmaceutical development program clearly depends on the efficacy of a medicine, thus biotech businesses creating novel compounds must take the development of analytical methods extremely seriously.
For both clinical trial applications and marketing authorizations, regulatory agencies across the world want analytical method validation.
Who should take the Analytical Method Development Exam?
- Analytical chemist
- Quality control chemist
- Quality assurance chemist
- Agricultural chemist
- Soil and plant chemist
- Analytical development scientist
- Technologist
Analytical Method Development Certification Course Outline
- Analytical Methods Development
- Liquid Chromatography
- Advanced Analytical Chemistry
- Spectroscopic Methods
- Gas Chromatography
- Polymer Charact & Analysis
- Analytical Chem in Pharm Labs