This guidance is intended to assist in applying current good manufacturing practice (cGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigation...
We will plan a course for your compound. Our global site network is the cornerstone of your FIH trial. First-in-human (FIH) studies are not a homogenous type. The U.S. FDA phase I trial, includes the initial human exposure to an investigational drug (IND). Phase I trials are relativel...
We (FDA) recommend that you use this guidance as a companion to otherFDA guidance documents describing the chemistry, manufacturing, and control (CMC) information submitted and reviewed in an IND application for phase 1 clinical trials.In many cases, at this stage of development manufacture of th...
The article focuses on the side effects of testing of the phase I clinical trials on human beings. According to David M. Geary, member of Oncology Nursing Society (ONS), patients must be educated about trials and should understand that they are research subjects. A table is presented that ...
The Clinical Research Unit — A nurse-led unit for cancer patients receiving chemotherapy in phase I clinical trials - European Journal of Cancerdoi:10.1016/S0959-8049(97)86385-XCameronC.esEuropean Journal of Cancer
In summary, primary objectives of this phase I clinical study were met, establishing feasibility and safety of locoregionally delivered IL-13Rα2-CAR-T cells for treatment of rHGG and rGBM. Although we do not intend to proceed with arms 1–4 for future phase trials, these initial arms pro...
This trial was registered at www.clinicaltrials.gov as #NCT01885897. Visual Abstract Download: Download high-res image (81KB) Download: Download full-size imagePrevious article in issue Next article in issue Sorry, something went wrong. Please try again and make sure cookies are enabledReferences...
Marti, F. (2005), Lean Six Sigma Method in Phase 1 Clinical Trials: A Practical Example. Quality Assurance Journal, 9, 35-39.Martin, F. (2005). Lean six sigma method in phase 1 clinical trials: A practical Example. Quality Assurance Journal, 9, 35-39....
and to preliminarily define the antitumor activity of Seprehvir within the confines of a phase 1 trial (https://clinicaltrials.gov/; ClinicalTrials.gov: NCT00931931) by modified RECIST (response evaluation criteria in solid tumors) criteria and metabolic activity on positron emission tomography (PET...
The purpose of this first-in-human, open-label, Phase 1 trial (ClinicalTrials.gov, identifier: NCT02157792) was to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumour activity of berzosertib in combination with gemcitabine, with or without cisplatin. ...