2001 Drug Development Regulations Trials 
Drug Discovery World
NOVEMBER 29, 2022
The curriculum and assessment structure is based on what the students will need to thrive in the drug development sector, with all scientific topics taught with the drug in mind first. Starting with the drug. Pharmacokinetics: How the body handles drugs. Pharmacodynamics: How drugs exert their effects on the body.
Agency IQ
AUGUST 16, 2024
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions.
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The Pharma Data
DECEMBER 15, 2020
As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.
Drug Discovery World
JANUARY 23, 2023
Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. The CTR replaced and expanded on the scope of the existing EU CT Directive (CTD) 2001/20/EC.
Conversations in Drug Development Trends
MAY 23, 2024
By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.
Drug Discovery World
AUGUST 2, 2023
PPT1 inhibitors for the treatment of patients with cancer Contemplating the potential of PPT1 inhibition in cancer led to the development of small molecules with high PPT1 affinity and limited toxicity for clinical drug development. Palmitoylation as a Key Regulator of Ras Localization and Function.
FDA Law Blog: Drug Discovery
APRIL 23, 2023
This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. For example, objective response rate is often used as a single-arm trial endpoint in oncology given the established understanding that tumor shrinkage rarely occurs without an intervention.”
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