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Issue 18 ― Planning Your First-in-Human Trial
In this issue, we discuss how to plan for your first-in-human clinical trial.
Click here to download a PDF, readable version of Issue 18: https://www.altasciences.com/sites/default/files/2022-03/The%20Altascientist_issue%2018_FIH_v9.pdf
A first-in-human clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity or biologic in humans. Typically, first-in-human trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using healthy normal volunteers, unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.
CHAPTERS:
- 0:00-2:50 ― Section 1: Introduction
- 2:50-3:48 ― Section 2: Selecting the Starting Dose
- 3:48-7:34 ― Section 3: Designing the Trial
- 7:34-12:36 ― Section 4: Planning for Subject Safety
- 12:36-15:18 ― Section 5: Identifying and Mitigating Potential Risks in Trial Conduct
- 15:18-17:16 ― Section 6: Recruiting, Educating, and Retaining Study Participants
- 17:16-20:23 ― Section 7: Planning Resources and Conducting the Trial
- 20:23-end ― Section 8: Conclusion
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
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By The Altascientist
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In this issue, we discuss how to plan for your first-in-human clinical trial.
Click here to download a PDF, readable version of Issue 18: https://www.altasciences.com/sites/default/files/2022-03/The%20Altascientist_issue%2018_FIH_v9.pdf
A first-in-human clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity or biologic in humans. Typically, first-in-human trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using healthy normal volunteers, unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.
CHAPTERS:
- 0:00-2:50 ― Section 1: Introduction
- 2:50-3:48 ― Section 2: Selecting the Starting Dose
- 3:48-7:34 ― Section 3: Designing the Trial
- 7:34-12:36 ― Section 4: Planning for Subject Safety
- 12:36-15:18 ― Section 5: Identifying and Mitigating Potential Risks in Trial Conduct
- 15:18-17:16 ― Section 6: Recruiting, Educating, and Retaining Study Participants
- 17:16-20:23 ― Section 7: Planning Resources and Conducting the Trial
- 20:23-end ― Section 8: Conclusion
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.