Clinical Development Clinical Pharmacology Pharmacokinetics Pharmacy 
Alta Sciences
OCTOBER 30, 2023
Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Listen here. Watch it now.
Agency IQ
SEPTEMBER 15, 2023
The committee also made recommendations regarding pharmacokinetic and safety assessments. Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition.
Agency IQ
DECEMBER 11, 2023
The data used to generate a control arm may be derived from prior clinical trial data (individual or pooled), or observational, real-world data (RWD), such as from registries, electronic health records (EHRs), and medical or pharmacy claims.
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