Preparation of Shouktik Bhasma (SB) involves intermittent trituration of heated material with Aloe vera juice.
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Spherical Crystallization of Celecoxib
Celecoxib exhibits poor flow properties and compressibility.
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Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods
Sumanirole is a highly D2-selective dopamine receptor agonist that is in development for the treatment of Parkinson's disease (PD). Metabolism of sumanirole and in vitro data indicate that…
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Evaluation of the Relationship Between Sumanirole Exposure and Orthostatic Hypotension
Sumanirole is a selective D2 receptor agonist in development for treatment of Parkinson's disease (PD). This agent is expected to have a better safety profile compared to other dopaminergic agents…
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Evaluation of Covariate Effects on Population Pharmacokinetics (PPK) of Both Parent Drug and Metabolite(s) from Clinical Trial Data without Metabolite Administration or Excretion Sampling
To evaluate the influence of covariates on the PPK of both parent drug and metabolite(s) from clinical trial data with neither separate metabolite administration nor excretion sampling.
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Pharmacokinetics/Pharmacodynamics in Otitis Media: Comparison of Time-Dependent Antibiotics in Middle Ear Fluid
An effective dosing regimen of b-lactam and macrolide antibiotics for otitis media involving S. pneumoniae (SP) requires that drug concentrations in middle ear fluid (MEF) remain above the MIC (T>MIC)…
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Factors Influencing The Pharmacokinetics (Pk) Of The Anticancer Drug Irinotecan (Cpt-11) And Its Major Metabolites, Sn-38 And Sn-38g
To evaluate significant covariate effects on the PK of CPT-11 (C), SN-38 (S) and SN-38G (G).
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Prediction of intestinal absorption: comparative assessment of GastroPlus and IDEA
We have assessed two commercial software tools employing physiologically based models for prediction of intestinal absorption in human.
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Population Pharmacokinetics (PK) Of Linezolid In Neonates And Young Infants
Linezolid (LZD) is the first approved oxazolidinone antibiotic and has shown broad activity against gram-positive bacteria, including VRE and MRSA. Previous studies indicated LZD clearance was higher in…
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Population Pharmacodynamic Assessment of Atazanavir Exposure, Uridine Diphosphate-Glucuronosyl Transferase (UGT) 1A1 Genotype and Safety in Healthy Subjects
Atazanavir (BMS-232632) is a potent HIV-protease inhibitor with a favorable resistance profile in vitro. Dose-related elevations of total bilirubin (primarily unconjugated) have been observed with…
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Rule Extraction from a Mutagenicity Data Set Using Adaptively Grown Phylogenetic-like Trees
A public bacterial mutagenicity database was classified into 2-D structural families using a set of specific algorithms and clustering techniques that find overlapping...
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Analysis of Large Screening Data Sets via Adaptively Grown Phylogenetic-Like Trees
As the use of high-throughput screening systems becomes more routine in the drug discovery process, there is an increasing need for fast and reliable analysis of the massive...
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A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study
Real-time data assembly (RTDA) to support knowledgebased decision making was implemented for the development of a compound during Phase II. Program goals were to develop a data warehouse to expedite…
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Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
Numerous risks are associated with allogeneic blood transfusions, however non-allogeneic blood options can minimize the use of allogeneic blood. This study compared infection rates associated with blood…
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Data Analysis of High-Throughput Screening Results: Application of Multidomain Clustering to the NCI Anti-HIV Data Set
The routine use of high-throughput screening (HTS) systems in the drug discovery process has resulted in an increasing need for fast, reliable analysis of massive amounts of data.
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Rapid Assessment of Data Set Structures
When SAS® data is received from an external source, such as a sponsor, CRO, or another department, it is important to assess the new data to determine if variables have been added or removed, locate…
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Simultaneous Population Pharmacokinetic (PBK) Modeling of Irinotecan (CPT-11) and its Major Metabolites, SN 38 and SN-38G
To develop a PPK model in NONMEM® that simultaneously predicts the plasma concentration (Cp) profiles of CPT-11 (C) and its metabolites, SN-38 (S) and SN-38G (G).
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Uniqueness of Solutions to Compartmental Models of Population Pharmacokinetics for Drugs Undergoing Complex Metabolism
To investigate parameter identifiability and uniqueness of solutions to compartmental population pharmacokinetic (PPK) models for drugs with complex metabolism.
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Comparison of Laboratory Safety Data from Japanese and Non-Japanese in Linezolid Phase I Studies
The laboratory safety data of linezolid (lzd) pooled from 6 multi-dose Phase I studies were compared in 65 Japanese (J) and 56 non-Japanese (non-J) subjects.