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Issue 17 ― Maximizing Drug Formulation for First-in-Human Trials
In this issue, we discuss how to maximize drug formulation for first-in-human clinical trials.
Click here to download a PDF, readable version of Issue 17: https://www.altasciences.com/sites/default/files/2021-05/The-Altascientist_issue17.pdf
The main objective of first-in-human trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks, and allows the highest dosage and benefit for the intended trial. The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during first-in-human trials can be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key − ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval.
CHAPTERS:
- 0:15 ― Section 1: The Key Role of Formulation in Drug Development
- 3:45 ― Section 2: Formulation
- 7:25 ― Section 3: The Impact of Formulation on Subject Safety
- 10:09 ― Section 4: A Pharmacy Case Study ― Supporting Regulatory Approval
- 11:43 ― Section 5: Manufacturing Case Study ― Mission Impossible to Possible
- 13:20 ― Section 6: Integrating to Maximize Chances for Success
- 14:36 ― Conclusion
About Altasciences:
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 maximize drug formulation for first-in-human clinical trials.
Click here to download a PDF, readable version of Issue 17: https://www.altasciences.com/sites/default/files/2021-05/The-Altascientist_issue17.pdf
The main objective of first-in-human trials is to determine the starting dose of a new drug, one that is low enough to provide minimal to no safety and toxicity risks, and allows the highest dosage and benefit for the intended trial. The manufacture of the drug product for clinical trials is of critical importance, as the formulation, manufacturing, and assessment of a drug candidate during first-in-human trials can be contributing factors in whether the drug safely provides the correct dosage and, ultimately, gains regulatory approval. Decisions made during early phase development, when the compound is being used in a clinical research setting, provide significant learnings for its progression through later phase research. Integration is key − ensuring that information gathered at the clinic is efficiently incorporated into the manufacturing process is a major contributor to the goal of achieving marketing approval.
CHAPTERS:
- 0:15 ― Section 1: The Key Role of Formulation in Drug Development
- 3:45 ― Section 2: Formulation
- 7:25 ― Section 3: The Impact of Formulation on Subject Safety
- 10:09 ― Section 4: A Pharmacy Case Study ― Supporting Regulatory Approval
- 11:43 ― Section 5: Manufacturing Case Study ― Mission Impossible to Possible
- 13:20 ― Section 6: Integrating to Maximize Chances for Success
- 14:36 ― Conclusion
About Altasciences:
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.