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Formulation Changes and Bridging During Formulation Development – Part 2 Deepak Hegde
November 22, 2024
It focus on the real-life examples of bridging studies due to formulation changes from clinical study to commercialization of drug and real-life examples of bridging studies due to Reformulation (formulation changes) post commercialization of drug.
Formulation Changes and Bridging During Formulation Development – Part 1 Deepak Hegde
November 22, 2024
an outline of formulations change during development, details of the kind of Formulation changes from Phase 1 clinical study to commercialization of drug, Formulation changes Post-Approval and Commercialization.
CStone presents registrational bridging study data for GAVRETO® (pralsetinib) highlighting efficacy and safety in Chinese patients with advanced RET fusion-positive non-small cell lung cancer at IASLC prnasia
September 13, 2021
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines...
Ascletis Announces Dosing of the First Cohort of Healthy Subjects in the FXR Agonist ASC42 Bridging Study for Chronic Hepatitis B Indication in China prnasia
July 13, 2021
Ascletis Pharma Inc. today announces the dosing of the first cohort of healthy subjects in the ASC42 bridging study in China for CHB indication.
Bridging the Gaps Eases COVID Safety Protocols and Expands In-Person Services prnewswire
May 28, 2021
After more than a year of adhering to strict safety measures to help tamp down the spread of the virus, BTG is finally able to ease some of its protocols and restart services that that were temporarily restricted or delivered virtually.
CStone Announces Preliminary Results from a Bridging Study of Avapritinib in Chinese Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors at the 2020 CSCO Annual Meeting prnasia
September 27, 2020
CStone Pharmaceuticals (SUZHOU) Co., Ltd. presented positive results at the 2020 Chinese Society of Clinical Oncology (CSCO) Annual Meeting from a phase I/II bridging study in China evaluating avapritinib in patients with unresectable or metastatic ...
Bridging Study in China Completed for NASH Drug Candidate ASC40 prnasia
July 20, 2020
Ascletis Pharma Inc. (HKEX code: 1672) announces today that a single-dose, pharmacokinetic bridging study of non-alcoholic steatohepatitis (NASH) drug candidate ASC40 (TVB-2640) in 34 Chinese subjects has been completed and data indicates that key pharma
Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (NASH) drugs
May 09, 2019
Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (NASH).
Study of Selonsertib in Bridging Fibrosis Study Does Not Meet Primary Endpoint americanpharmaceuticalreview
April 26, 2019
Gilead Sciences announced that STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational ...