How Can Clinical Affairs Play The Role Of


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How Can Clinical Affairs Play The Role Of

  1. 1. How can Clinical Affairs play the role of a catalyst in FD?
  2. 2. Steps in Formulation Development Key steps in Formulation Development • PIF • Preparation of PDP • Identification of API source; identification of excipients & their source- all needed to formulate a dosage form – API characterization / excipient compatibility • RLD request • Trial batches • Analytical method development/validation • Pilot batch manufacture / Stability • Development Report • Exhibit batch PIF= project initiation form; PDP=Product Development Plan
  3. 3. Clinical Affairs as a catalyst Inputs that clinical affairs can give at different steps in formulation development • PIF – inputs on clinical study approach & cost estimate • Inputs for PDP preparation – Formulate clinical strategy based on PK/PD and clinical profile of drug • RLD request – Calculate RLD required (study + retention samples) for pilot & pivotal studies based on study plans
  4. 4. Clinical Affairs as a catalyst • Communicate with FDA and seek their input on – Appropriate dissolution method for a drug – Biowaiver (wherever applicable) – BE study design
  5. 5. Clinical Affairs as a catalyst • Pilot batch is taken – Review dissolution studies data along with ASD & FD teams • Decision on going for biostudy with that batch – Design a pilot study & plan the same
  6. 6. Clinical Affairs as a catalyst • Review results of pilot study or studies – provide inputs on need to reformulate or continue with same formulation • E.g. Test product shows a variability > reference product- test product must be reformulated – results of study vs. dissolution data – prepare summary of pilot study data for product devpt. report
  7. 7. Clinical Affairs as a catalyst • Plan, design and monitor Pivotal BE study – Review COAs for test and reference product before shipping to CRO • Review dissolution data along with FD/ASD – Decide on suitability of batch to go for BE study • Review pivotal study data / resolve queries
  8. 8. Regulatory support • Dossier Preparation – BE study data – compilation and integration into dossier – Inputs on pack insert, patient information leaflets / scientific rationales in case of FDCs etc. • Reply to queries on BE from regulatory agency