Target Product Profile

A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA Guidance for Industry and Review Staff Target Product Profile — A Strategic Development Process Tool.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf.

Below is an example worksheet based on the FDA guidance that defines the minimal/ideal profile of the final marketed product and shows the ultimate goals of the proposed therapy development effort.

Download Version (pdf)

Product PropertiesMinimum Acceptable ResultIdeal Result
Primary IndicationRelief of pain symptoms in diabetic neuropathyRelief of symptoms in neuropathic pain syndromes
Patient PopulationAdults with diabetes who experience neuropathic painAdults and children with neuropathic pain
Treatment DurationChronicChronic
Delivery ModeOralOral
Dosage FormTablet or capsuleTablet or capsule
Regimen1–2x/day1x/day
EfficacyA 40% decrease in pain score in 30% of patientsA 70% decrease in pain score in 50% of patients.
Risks/Side EffectsDevoid of opioid side effects
Devoid of GI side effects from Non-steroidal anti-inflammatory drugs (NSAIDs)
Minor or moderate CNS side effects
Devoid of opioid side effects
Devoid of GI side effect from NSAIDs
No CNS side effects