What would an ideal drug discovery/drug development process look like


looking for better solution

in progress 0
sabitasinha 2 months 1 Answer 38 views 0

Answer ( 1 )

  1. An ideal drug development services process should start with setting a Target Product Profile (TPP) and Quality Target Product Profile (QTPP) for drug product primarily based on API properties, therapeutic indication and target patient-population. This is followed by understanding critical quality attributes (CQAs) of the drug product, and contemplating the impact of critical material attributes (CMAs), formulation variables (CFVs) and process parameters (CPPs) on drug product CQAs, which are derived from the process of ‘’risk assessment’’ (RA). At this stage, it is imperative that formulators make use of sound scientific knowledge of API properties, formulation and process parameters to link these attributes with drug product CQAs. RA provides a basis to design experimental plans for drug development. Based on RA, the high risk factors are evaluated through experimental plan such as design of experiments (DOE) to understand precisely the impact of these factors on drug product CQAs. Importantly, the in-vitro assessment tools such as selection of dissolution conditions and analytical methods are key to successful development at this stage.For better result https://www.piramalpharmasolutions.com/development
    The next crucial step is to scale up the processes. It involves varied challenges depending on batch size, equipment available/required and product characteristics. Ideally, each scale up can be ensured based on scientific scale-up principles and product/process knowledge. The empirical studies so far shall derive a control-strategy, which embodies the range for each attribute in which it can be controlled in order to manufacture drug product complying with the predefined specifications of the quality-attributes. Finally, efforts is made to achieve continuous improvement in drug development process during product lifecycle management.

Leave an answer


Anonymous answers

By asking your question, you agree to the terms of service and Privacy Policy.