B Rojek, M Wesolowski - Journal of Thermal Analysis and Calorimetry, 2023 - Springer
Differential scanning calorimetry (DSC) is a tool particularly recommended for rapid compatibility screening between active pharmaceutical ingredients (APIs) and excipients …
SL Conway, KJ Rosenberg, S Sotthivirat… - Journal of …, 2024 - Elsevier
Assessing the robustness of a drug product formulation and manufacturing process to variations in raw material (RM) properties is an essential aspect of pharmaceutical product …
By means of a science and risk-based systematic approach to pharmaceutical product development through the DoE/QbD system, a control strategy will be defined for each of the …
K Nemoto, Y Hayashi, H Sugiyama - International Journal of Pharmaceutics, 2024 - Elsevier
This work presents an indicator-based assessment of potential supply risks for pharmaceutical excipients. The assessment was conducted systematically through the steps …
Dosage forms containing Ivermectin (IVER) and Praziquantel (PRAZ) are important combination drug products in animal health. Understanding the relationship between …
AS Hussain, K Morris, VJ Gurvich - AAPS PharmSciTech, 2021 - Springer
The AAPS PharmSciTech Theme Issue entitled “Team Science and Education for Pharmaceuticals-the NIPTE Model” curates nineteen papers (1–19) listed in Table I and …
Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic …