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.
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.
|Product Properties||Minimum Acceptable Result||Ideal Result|
|Primary Indication||Relief of pain symptoms in diabetic neuropathy||Relief of symptoms in neuropathic pain syndromes|
|Patient Population||Adults with diabetes who experience neuropathic pain||Adults and children with neuropathic pain|
|Dosage Form||Tablet or capsule||Tablet or capsule|
|Efficacy||A 40% decrease in pain score in 30% of patients||A 70% decrease in pain score in 50% of patients.|
|Risks/Side Effects||Devoid 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