Defining Your Target Product Profile - MaRS Startup Toolkit
Emerging Life Sciences Series
Defining Your Target Product Profile: Therapeutics
Workbook Template
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Table of contents
1. Indications and usage 3
2. Dosage and administration 3
3. Contraindications 4
4. Adverse reactions 4
5. Clinical pharmacology 5
6. Non-clinical toxicology 5
7. Clinical studies 6
Appendix A (optional): Template for clinical trial protocol synopsis 7
1. Indications and usage
|Target |Annotations |
|Write a brief response to the following questions: |Supply a summary of completed or planned studies that support the |
|What is the drug product? |target. |
|Is it for treatment or prevention? | |
|What disease/condition does it target? | |
|Who are the target patients? | |
|Comments: |
|Create a summary of the drugs currently used for treatment or prevention in your target indication (maximum of four) and write a brief |
|statement on their competitive positioning. |
| |
| |
2. Dosage and administration
|Target |Annotations |
|Write a brief response to the following questions: |Supply a summary of completed or planned studies that support the |
|How much drug is required? |safety and effectiveness of the proposed dosage and route of |
|How is it administered? |administration. |
|How often is the treatment? | |
|What is the duration of treatment? | |
|Comments: |
|Summarize the positioning of the dosage and administration of your product relative to current treatments. |
| |
3. Contraindications
|Target |Annotations |
|Write a brief response to the following question: |Supply a summary of completed or planned studies that support the |
|Which patients should not be treated with this drug? |target. Alternatively, include literature references describing |
| |contraindications for the drug class. |
| | |
| | |
| | |
| | |
|Comments: |
|How do the contraindications compare with currently used therapies? |
| |
4. Adverse reactions
|Target |Annotations |
|Write a brief response to the following questions: |Supply a summary of completed or planned studies that support the |
|What adverse effects might be anticipated based on results of |target (include references to reported class-related drug effects). |
|pre-clinical studies? | |
|What adverse effects might be expected due to the drug class? | |
|What adverse reactions have been observed in clinical studies? | |
|Comments: |
|Identify adverse events associated with current drug treatments that might be mitigated by your new drug candidate. |
| |
5. Clinical pharmacology
|Target |Annotations |
|Write a brief response to the following questions: |Supply a summary of completed or planned studies that support the |
|What is the mechanism of action? |target. |
|How fast does the drug reach the target organ(s)? | |
|How is the drug distributed through the body? | |
|How long does the drug persist? | |
|How is the drug cleared from the body? | |
|Comments: |
|Create a short summary of key differentiators relative to current treatments. |
| |
| |
6. Non-clinical toxicology
|Target |Annotations |
|Write a brief response to the following questions: |Supply a summary of completed or planned studies that support the |
|What is the safety profile of the drug based on cells, tissues and |target. |
|organ systems assessed through in vitro and in vivo animal studies?| |
| | |
|What is the maximum tolerated dose in animals? | |
|What would be a safe starting dose in human studies? | |
|What are the effects of long-term exposure? | |
|Comments: |
|How will the non-clinical toxicology compare with current therapies? |
| |
7. Clinical studies
|Target |Annotations |
|Write your desired statements regarding your product’s clinical |Supply a summary of completed or planned studies that (will) develop|
|efficacy or safety benefits. Remember to consider: |evidence in support of treatment (i.e., safety or efficacy benefits |
|What is the clinical evidence to support the indication claims? |of primary or secondary endpoints in the selected population). |
|How strong is the evidence? | |
|What is the safety profile? | |
|How will the endpoints in the clinical study (studies) support the | |
|competitive positioning and marketing strategy for the new drug? | |
|Comments: |
|Identify the key areas of your product’s competitive advantage. |
| |
| |
Appendix A (optional):
Template for clinical trial protocol synopsis
The following template provides an outline for preparing clinical protocols. Each field highlights a key element for consideration.
|Protocol title | |
|Protocol number | |
|Name of sponsor | |
|Drug substance | |
|Investigational drug product | |
|Phase of development | |Indication: | |
|Principal investigator | |
|Study centre(s) | |
|Objectives |Primary objectives: |
| |Secondary objectives: |
|Study design | |
|Planned number of subjects | |
|Subject population | |
|Diagnosis | |
|and inclusion/ exclusion | |
|criteria | |
|Reference product | |
|Treatment regimens | |
|Duration of treatment | |
|Safety monitoring | |
|Endpoints |Primary endpoints: |
| |Secondary endpoints: |
|Statistical methods |Safety: |
| |Efficacy: |
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