Drug Discovery World

JULY 25, 2023

Ethical considerations Given the vulnerable status of children, safeguards are needed when including a paediatric population in clinical investigations of drugs and medical devices. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

New Drug Approvals

SEPTEMBER 10, 2024

It was developed for schizophrenia and anhedonia in depression but trials were unsuccessful and its development was discontinued in 2023. [1] Zelatriazin, C 18 H 15 F 3 N 4 O 3 , 392.3 X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1 Hz, 1 H), 5.09 (s, 2 H), 7.33 (d, J=7.8 Hz, 1 H); ESI-MS m/z [M+H] + 393.9.

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *© All rights reserved.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52