How Can Clinical Affairs Play The Role Of
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Clinical Affairs can play a catalytic role at various steps of formulation development by providing inputs. Some ways they can contribute include estimating clinical study costs and designing clinical strategies during project planning, calculating drug requirements for studies during product development planning, communicating with regulators on dissolution methods and biowaivers, reviewing dissolution and pilot study data to decide on further formulation or biostudies, planning and monitoring pivotal biostudies, and assisting with regulatory dossier preparation and responses.
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Ms. Prexa Nitin Shah is seeking a position in regulatory affairs or quality assurance. She has a Master's degree in regulatory affairs from Northeastern University and a Bachelor's degree in pharmacy from Gujarat Technological University. She has experience as a quality technician at Invatech Pharma Solutions and as a quality assurance associate at Intas Pharmaceuticals. She is skilled in FDA submissions and global drug regulations. She also has strong documentation, analytical, and communication skills.
The importance of quality assurance
Quality assurance in clinical research involves systematically examining all trial activities and documents to ensure compliance. This includes ensuring data collected matches the protocol and source documents. Components of quality include thorough standard operating procedures, trained personnel, proper document management, and corrective action plans. Regular audits of regulatory documents, source documents, and case report forms help ensure accuracy and protocol adherence.
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How Can Clinical Affairs Play The Role Of
- 1. How can Clinical Affairs play the role of a catalyst in FD?
- 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. 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. 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. 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. 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. 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. 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