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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
June 03, 2021
The added capabilities include clinical-scale sachet and blister packaging for clinical trial pharmaceuticals and a relationship with a European Union Qualified Person for its CTS offerings.
May 20, 2021
The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.
May 15, 2021
Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
May 06, 2021
FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.
March 30, 2021
SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.
March 16, 2021
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
March 01, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
February 02, 2021
New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?
January 28, 2021
January 11, 2021
A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.