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Printable Handouts
Navigable Slide Index
- Introduction
- Outline
- Phase I study: role in clinical drug development
- Clinical drug development
- Phase I study
- Terminology
- Phase I study design
- Phase I study objectives
- Phase I study design: preclinical requirements
- Preclinical data PD checklist: efficacy
- Preclinical data PD checklist: target modulation
- Preclinical data PD checklist: toxicity
- Preclinical data PK checklist
- Phase I study conduct
- Determination of the RPTD
- Cytotoxic agent
- Patient population
- Starting dose
- Dose escalation
- Dose escalation methods (1)
- Dose escalation methods (2)
- Phase I study design for non-cytotoxic agents
- Challenges for evaluation of non-cytotoxic agents
- Non-cytotoxic agents (1)
- Non-cytotoxic agents (2)
- Population
- Non-cytotoxic agents: starting does and escalation
- Non-cytotoxic agents: RPTD determination
- Primary endpoint: toxicity
- Primary endpoint: PK
- Primary endpoint: target effects
- Target effects: role in phase I study conduct
- Approaches to phase I study design
- Example of phase I study conduct
- General considerations for RPTD determination
- Phase I study of non-cytotoxic agent
- Clinical trial sample analyses
- Examples of non cytotoxic phase I studies
- Cetuximab
- Erlotinib
- O6-benzylguanine
- Phase I review
- Agents/targets
- Recommended phase II dose and primary basis
- Laboratory and imaging studies
- Summary
- References
Topics Covered
- Phase I study development: role in clinical drug development
- Terminology
- Phase I study objectives
- Preclinical data requirements
- Efficacy
- Target modulation
- Toxicity
- PK checklist
- Phase I study conduct
- Determination of the RPTD
- Cytotoxic agent
- Patient population
- Starting dose
- Dose escalation
- Dose escalation methods
- Phase I study design for non-cytotoxic agents
- Challenges for the evaluation of non-cytotoxic agents
- Two approaches to study phase I study design driven by target effects
- General considerations for RPTD determination
- Clinical trial sample analyses
- Examples: Cetuximab, Erlotinib, O6-Benzylguanine
- Phase I review
- Agents/targets
- Recommended phase II dose and primary basis
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Parulekar, W. (2009, January 6). Phase I study design for non-cytotoxic agents [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 5, 2024, from https://doi.org/10.69645/IVPT3010.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Wendy Parulekar has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.