Pharmaceutical Technology
JUNE 10, 2023
RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. According to GlobalData, Phase II drugs for Hyperinsulinemia does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RZ-358 LoA Report.
Cloudbyz
JUNE 10, 2023
21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. Food and Drug Administration (FDA). Its central focus is electronic records and signatures. These rules serve as a regulatory benchmark, allowing digital transactions to be as trustworthy and reliable as paper ones.
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Pharmaceutical Technology
JUNE 10, 2023
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report.
pharmaphorum
JUNE 10, 2023
FDA panel gives unanimous support to Leqembi Phil.
Pharmaceutical Technology
JUNE 10, 2023
PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how PB-357’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Drug Patent Watch
JUNE 10, 2023
This chart shows the patent expirations for solution dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from… The post Solution dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 10, 2023
TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
NuGel is under clinical development by Shaperon and currently in Phase I for Sepsis. According to GlobalData, Phase I drugs for Sepsis does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the NuGel LoA Report. Buy the report here.
Pharmaceutical Technology
JUNE 10, 2023
RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. According to GlobalData, Phase II drugs for Upper Limb Muscle Spasticity does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RT-002 LoA Report.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JUNE 10, 2023
RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. According to GlobalData, Phase II drugs for Hyperinsulinemia does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RZ-358 LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how PB-357’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Pharmaceutical Technology
JUNE 10, 2023
CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the CIGB-128 LoA Report.
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Pharmaceutical Technology
JUNE 10, 2023
TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report.
Pharmaceutical Technology
JUNE 10, 2023
NuGel is under clinical development by Shaperon and currently in Phase I for Sepsis. According to GlobalData, Phase I drugs for Sepsis does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the NuGel LoA Report. Buy the report here.
Pharmaceutical Technology
JUNE 10, 2023
RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. According to GlobalData, Phase II drugs for Upper Limb Muscle Spasticity does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RT-002 LoA Report.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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