What is method scouting?
Method scouting is the term used to describe the assessment of potential test methods during the early stages of product development, when there is limited knowledge of the types of analytical procedures that may be applicable or appropriate to the product.
Method scouting involves a series of “rough and ready” experiments that are designed to determine whether a method is applicable to a test article. Scouting experiments can form part of the method development phase, and are always performed prior to method optimisation and validation. This is due to the data obtained playing an important part in the development of subsequent validation ranges and criteria.
This may be depicted as follows:
Method scouting and pharmaceutical development
Method scouting is a highly technical area and requires specialist analytical knowledge as well as product knowledge, expertise of analytical procedures and the target molecules. It is used in subsequent pharmaceutical development steps including:
- Manufacturing process development and refinement
- Formulation development
- Stability evaluation
- Establishing specifications
- Establishing Quality Control (QC) test methods and product quality specifications (PQS)
Robust and well-documented method scouting is vital during preparation of the pharmaceutical development sections of the dossier.
Need further information?
Woodley BioReg are experts in a wide range of analytical methods and product types to help and advise clients on procedures and techniques available throughout the development and registration stages of a product.
WBR provides expert guidance and consultation gained through practical and successful industry experience in order to develop methods that can be validated and documented in eCTD.