Coaching & Mentoring service

Establish the Target Product Profile (TPP)

Provided by GPRS Gombert Pharma Research Solutions · Switzerland

Service description

The Target Product Profile is a central dynamic document of the preclinical research to define the and manage the therapeutic goals and properties of the new drug. It is the first part of the Quality by Design concept. Implemented now by the major drug approval agencies, e.g. EMA, FDA, NMPA and part of the ICH guideline Q8 (R2) on pharmaceutical development guidelines. GPRS supports the customers to establish the document by identification of the profitable disease area, patient population, route of administration, delivery system, dosage form, required pharmacokinetic properties needed to generate the therapeutic effect, safety parameters, potential side effects and anti target profile, and quality of the active pharmaceutical ingredients (API). We develop this together with clinical experts in our network together with the customers.

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