AIMC Topic: Therapeutic Equivalency

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Machine learning driven bioequivalence risk assessment at an early stage of generic drug development.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V Oct 26, 2024
BACKGROUND: Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development. The aim of our study was to develop a model-based approa...
Humans Machine Learning Risk Assessment Biological Availability Therapeutic Equivalency Drugs, Generic Drug Development Bayes Theorem Solubility
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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.

The AAPS journal Apr 8, 2024
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes ...
United States Drug Development Artificial Intelligence United States Food and Drug Administration Therapeutic Equivalency Drugs, Generic
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Interpretation of machine learning models using shapley values: application to compound potency and multi-target activity predictions.

Journal of computer-aided molecular design May 2, 2020
Difficulties in interpreting machine learning (ML) models and their predictions limit the practical applicability of and confidence in ML in pharmaceutical research. There is a need for agnostic approaches aiding in the interpretation of ML models re...
Humans Drug Discovery Pharmaceutical Preparations Structure-Activity Relationship Neural Networks, Computer Therapeutic Equivalency Machine Learning Models, Molecular
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Bioequivalence of fixed-dose combinations of dapagliflozin and metformin with single-component tablets in healthy subjects and the effect of food on bioavailability.

Clinical pharmacology in drug development Oct 20, 2015
The pharmacokinetics (PK) of dapagliflozin and metformin administered as fixed-dose combination (FDC) tablets (2.5 mg dapagliflozin/850 mg metformin or 5 mg dapagliflozin/1000 mg metformin) or as separate tablets in healthy subjects were evaluated in...
Area Under Curve Glucosides Tablets Biological Availability Young Adult Food-Drug Interactions Fasting Cross-Over Studies Humans Middle Aged Adult Metformin Hypoglycemic Agents Benzhydryl Compounds Adolescent Female Male Therapeutic Equivalency Drug Combinations
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The advantages of combination therapy on hypertension: development of immediate release perindopril-indapamide tablet and assessment of bioequivalence studies.

Pharmaceutical development and technology Oct 13, 2015
Hypertension has a major associated risk for organ damage and mortality, which is further heightened in patients with prior cardiovascular events, comorbid diabetes mellitus, microalbuminuria and renal impairment. Convers Plus tablet including perind...
Tablets Administration, Oral Cross-Over Studies Drug Combinations Area Under Curve Indapamide Perindopril Angiotensin-Converting Enzyme Inhibitors Chemistry, Pharmaceutical Therapeutic Equivalency Humans Young Adult Adult Male Middle Aged Hypertension
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Bioequivalence and comparative pharmacodynamics of insulin lispro 200 U/mL relative to insulin lispro (Humalog®) 100 U/mL.

Clinical pharmacology in drug development Oct 5, 2015
Insulin lispro 200 U/mL (IL200) is a new strength formulation of insulin lispro (Humalog®, IL100), developed as an option for diabetic patients on higher daily mealtime insulin doses. This phase 1, open-label, 2-sequence, 4-period crossover, randomiz...
Therapeutic Equivalency Glucose Clamp Technique Insulin Lispro Area Under Curve Cross-Over Studies Young Adult Adult Humans Male Female Middle Aged Hypoglycemic Agents Dose-Response Relationship, Drug
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PHARMACOKINETICS AND BIOEQUIVALENCE STUDIES OF TWO NIMESULIDE 100 mg TABLETS: UNIT DOSE, RANDOMIZED-SEQUENCE, TWO-WAY CROSSOVER STUDY IN HEALTHY VOLUNTEERS OF PAKISTANI POPULATION.

Acta poloniae pharmaceutica Mar 1, 2017
Single centered crossover, two cycles volunteer study was performed on 12 healthy male volunteers. Both reference and test, immediate release nimesulide formulation was given in a randomized manner with a washout period of 15 days and 5 mL of blood s...
Models, Biological Healthy Volunteers Male Sulfonamides Tablets Half-Life Anti-Inflammatory Agents, Non-Steroidal Chromatography, High Pressure Liquid Administration, Oral Metabolic Clearance Rate Area Under Curve Pakistan Therapeutic Equivalency Cross-Over Studies Humans Young Adult
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