Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Phases of clinical research - Wikipedia
Making pharmaceutical research and regulation work for women | The BMJ
SEC Filing - Wave Life Sciences
Clinical Research Whitepapers (CRO) | Simbec-Orion
PDF) Pre-clinical Data Analysis Ensuring Relevant First-in Human Clinical Trials
Clinical trial - Wikipedia
Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials - Cytotherapy
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical…
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension | Nature Medicine
Harmonization of U.S., European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible? | Journal of Nuclear Medicine
PDF) An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials
Phase I and first-in-human Clinical Trials and FDA's CGMP Requirements
CONSORT diagram for LEISH1 first-in-human clinical trial.... | Download Scientific Diagram
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics - Pearl Pathways
Harmonization of U.S., European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible? | Journal of Nuclear Medicine
G.500 - PHS Human Subjects and Clinical Trials Information
EMA publishes revised guidelines to reduce risk in first-in-human clinical trials - The Pharmaceutical Journal
Phase I and first-in-human Clinical Trials and FDA's CGMP Requirements
Early phase clinical trials extension to guidelines for the content of statistical analysis plans | The BMJ
Evaluating eligibility criteria of oncology trials using real-world data and AI | Nature
