Results 121 to 130 of about 455 (133)
Some of the next articles are maybe not open access.
AAPS PharmSciTech, 2023
Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models.
Tausif Ahmed +2 more
exaly +3 more sources
Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models.
Tausif Ahmed +2 more
exaly +3 more sources
Applications of PBPK/PBBM modeling in generic product development: An industry perspective
Journal of Drug Delivery Science and Technology, 2022Tausif Ahmed, Sivacharan Kollipara
exaly +2 more sources
Journal of Pharmaceutical Sciences, 2022
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
Fady Ibrahim
exaly +3 more sources
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
Fady Ibrahim
exaly +3 more sources
Journal of Pharmaceutical Sciences, 2022
Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg. The reference and test formulations have salt-A & salt-B of API but both products were bioequivalent based on the in vivo bioequivalence study conducted for higher strength 100mg. While leveraging the generic product to different market, the
Adithya Karthik Bhattiprolu +4 more
openaire +2 more sources
Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg. The reference and test formulations have salt-A & salt-B of API but both products were bioequivalent based on the in vivo bioequivalence study conducted for higher strength 100mg. While leveraging the generic product to different market, the
Adithya Karthik Bhattiprolu +4 more
openaire +2 more sources
Journal of Pharmaceutical Sciences
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has demonstrated its utility in both new drug and generic product development. Applications of PBBM for fed bioequivalence study waivers is an upcoming area. Recently Innovation & Quality (IQ) consortium demonstrated utility of PBBM to avoid repeat food effect studies for
Tausif Ahmed, Sivacharan Kollipara
exaly +3 more sources
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has demonstrated its utility in both new drug and generic product development. Applications of PBBM for fed bioequivalence study waivers is an upcoming area. Recently Innovation & Quality (IQ) consortium demonstrated utility of PBBM to avoid repeat food effect studies for
Tausif Ahmed, Sivacharan Kollipara
exaly +3 more sources
AAPS PharmSciTech
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM).
Anagha Damre, Aniruddha Banerjee
openaire +2 more sources
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM).
Anagha Damre, Aniruddha Banerjee
openaire +2 more sources
PBBM modeling: empowering pharmacotherapy strategies for gastric bypass patients
The prevalence of obesity has surged, with gastric bypass surgery emerging as a primary treatment for severe cases.openaire +1 more source