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Why Pharma Companies Must Invest in Method Development & Validation

Method development is a key element of pharmaceutical development, and it can’t be overlooked when starting the process of creating a new drug. While it’s often considered routine, it’s integral to maintaining cost efficiency. With the right method development and validation guidelines in place, your company can optimize resources and save on development time. Optimize your lab resources and ensure you meet drug development objectives with method development.

Method development and validation are necessary and interconnected parts of the drug development process. With validated process and methods, you’ll create a better drug in less time that has more chance of success in the commercial market.

What is Method Development?

Method development measures the concentration of active pharmaceutical ingredients (API) in a dosage form. During the process of developing your drug, method development processes can also determine the multitude of constituents in your formulation. It’s important to use method development to work out the product’s purity, composition, and potency. By utilizing method development throughout the drug’s creation, your company can modify and refine your product throughout its advancement. Methods can also help test safety, assist in characterization studies, and evaluate drug performance. Method development is an integral part of drug formulation and should be incorporated into cost projections, project time, and lab time.

Why is Method Development Necessary for Drug Formulation?

Often, there is a lack of existing methods in pharmacopeias for the drug or combination of drugs you’re developing. If there are existing methods, they can be prohibitively expensively, requiring expensive reagents or solvents. When existing procedures need complex extraction or derivatization and can be unreliable, method development can help discover new means to formulate the product. Some common procedures used in method development are identification tests, quantitative tests for active moiety or impurity, and limits tests for control of impurities.

Method Validation

Any analytic methods you use for method development need to be validated to ensure they’re scientifically sound. Validation ensures any analytic methods you’re using are measuring the substances in your product in the appropriate ranges. Standard operating procedures (SOP) are always required in a lab, along with qualified and calibrated instrumentation. When you validate your procedures, you create an environment to test your drugs safely and accurately.

How Avomeen Can Help You

Avomeen’s scientists have developed custom FDA/ICH-compliant method development and validation protocols, based on industry standard guidelines. If your company needs help with drug development, Avomeen can help you perform the necessary method development and validation studies. Work with the experts at Avomeen to fast-track your drug development and ensure the safety of your products. Learn more about Avomeen here or contact us so we can assist you today.