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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. 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
Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.
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
Basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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 02, 2021
The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.
February 03, 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?
February 02, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.