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.

Analytical Method are needed to address various issues being faced by the industry in resolving not only operational but also strategic issues as well.

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
• Students who want to make career in Analytical Method Development
  

Knowledge and Skills required for the Analytical Method Development

Specific skills are needed to excel in career of analytical method development which includes analytical bent of mind and quick learning skills.

Analytical Method Development Practice Exam Objectives

Analytical Method Development exam focuses on assessing your skills and knowledge in concepts and application of Analytical Method Development

Analytical Method Development Practice Exam Pre-requisite

There are no prerequisites for the Analytical Method Development exam.

Analytical Method Development Certification Course Outline

1. Analytical Methods Development
2. Liquid Chromatography
3. Advanced Analytical Chemistry
4. Spectroscopic Methods 
5. Gas Chromatography
6. Polymer Charact & Analysis
7. Analytical Chem in Pharm Labs

Exam Format and Information

Certification name – Certificate in Analytical Method Development
Exam duration – 60 minutes
Exam type - Multiple Choice Questions
Eligibility / pre-requisite - None
Exam language - English
Exam format - Online
Passing score - 25
Exam Fees  - INR 1199