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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.
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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.
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How to Source Safe and Effective Antibiotic APIs for Pediatric Formulations
Saher Haider
December 09, 2024
Given children's unique physiological and pharmacokinetic characteristics, the development of pediatric antibiotic formulations requires stringent controls.
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Glucagon-like peptide-1 (GLP-1) Receptor Agonist Semaglutide in an Oleogel Formulation Using the BrainDos™ Technology Significantly Increases Drug Delivery into Cells
PharmaSources
May 09, 2024
MetP Pharma AG, leveraging the proprietary nose-to-brain drug delivery technology BrainDos™ in internal and external product development and manufacturing programs.
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Research Progresses of the Pharmacological Functions and New Formulations of Artemisinin and Its Derivatives
Xiao Michong/PharmaSources
May 22, 2023
Artemisinin is a sesquiterpene lactone compound with a peroxide group structure extracted from the leaves of artemisia annua, family Asteraceae.
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Brief Description of the Application of Hot Melt Extrusion in Pharmaceutical Formulations
PharmaSources/Shaluo
April 18, 2022
Hot Melt Extrusion (HME), also known as Melt Extrusion technique, refers to a technology in which drugs and carrier excipients are uniformly mixed in a molten state and extruded with a certain pressure, speed and shape.
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Formulation development of New chemical Entities (NCE’s) to commercialization
Deepak Hegde
June 16, 2021
The process of taking a new drug from concept to clinic and eventually to commercialization involves several steps which traditionally occur in series.
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The Layout of Inhalation Formulations in the Chinese Market (I)
PharmaSources/zhulikou431
June 24, 2020
Inhalation formulations are a dosage form with high technical barriers, with relatively few pharmaceutical enterprises entering this field at the beginning.
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The Layout of Inhalation Formulations in the Chinese Market (II)
PharmaSources/Zhulikou431
June 24, 2020
As the inhalation formulation market is developing in China, the Chinese government has gradually introduced favorable policies to offer support.
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IND Application for a Phase I/II Clinical Study of Anti-HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 was Approved
PRNewswire
December 27, 2024
Alphamab Oncology (stock code: 9966.HK) announced that a phase I/II clinical trial (Study ID: JSKN033-102) of JSKN033 has been approved by CDE of NMPA.