WHEN SHOULD YOU PERFORM FORMULATION DEVELOPMENT ACTIVITIES?
WHEN EARLY FORMULATION DEVELOPMENT IS NOT A FEASIBLE PATH? While formulation development activities are an essential step in drug development, there may be certain situations where it may not be necessary or advisable to perform. Some scenarios where early formulation development may not be appropriate include: • For compound with suitable physicochemical characteristics: Where a compound exhibits studies rather than using simple extemporaneously prepared dosing strategies, can improve clinical outcomes, reduce clinical timelines and provide an earlier insight into commercial considerations such as product cost of goods and process train requirements for scale up. In general, early formulation development activities are part of an iterative process, with regular data evaluations and product modifications as necessary, based upon clinical findings, stability data and refinement of the target product profile throughout a development programme. The goal is to achieve a stable, effective, and safe drug product that can be manufactured consistently and meets regulatory requirements.
Formulation development activities should ideally be performed as early as possible in the drug development process; typically in the preclinical phase, after the lead compound has been identified and characterized for its physicochemical properties. Some key stages of drug development when early formulation development can be performed include: • Following lead compound optimization: Once a lead compound (drug substance) has been identified, early formulation development can be initiated to design the formulation to overcome the challenges associated with the drug substance for improved drug delivery, stability, and efficacy. • Preclinical development: During the preclinical phase, early formulation development can aid dose delivery for toxicology studies and support PK modelling for determination of starting dose and route of administration when considering first in human (FIH) studies. The data gained from these formulations can help to assess the stability of the drug substance/product and identify potential issues with bioavailability and toxicity. • Phase I Clinical development: Performing formulation development activities to support FIH
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