Keywords: سیستم طبقه بندی بیولوژیک (BCS); dissolution; high throughput technology(s); oral absorption; Biopharmaceutics Classification System (BCS); formulation; in vitro model(s); permeation enhancers(s); solubility; supersaturation;
مقالات ISI سیستم طبقه بندی بیولوژیک (BCS) (ترجمه نشده)
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Keywords: سیستم طبقه بندی بیولوژیک (BCS); pediatric; Biopharmaceutics Classification System (BCS); in vitro models; physiologically based pharmacokinetic model; clinical trials;
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Biopharmaceutics Classification System (BCS); Drug solubility; Intestinal permeability; Solubility-enabling formulations; Solubility-permeability tradeoff;
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Biopharmaceutics Classification System (BCS); bioequivalence; excipients; oral absorption; permeability; cimetidine; acyclovir; ANDA; Abbreviated New Drug Application; BCS; biopharmaceutics classification system; BE; bioequivalence; HPMC; hydroxypropyl me
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Biopharmaceutics classification system (BCS); ex vivo; in vitro models; intestinal absorption; permeability; rat intestine segments
Keywords: سیستم طبقه بندی بیولوژیک (BCS); bioavailability; biopharmaceutics classification system (BCS); dissolution; excipients; formulation; gastrointestinal; in vitro models; intestinal absorption
Keywords: سیستم طبقه بندی بیولوژیک (BCS); intestinal absorption; salt selection; bioequivalence; biopharmaceutics classification system (BCS); in silico modeling; dissolution; food effects; formulation; gastrointestinal transit; oral absorption
Keywords: سیستم طبقه بندی بیولوژیک (BCS); ADME; bioavailability; biopharmaceutics classification system (BCS); clinical pharmacokinetics; clearance; formulation; oral absorption; physiological model; preclinical pharmacokinetics; solubility
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; active transport; Biopharmaceutics Classification System (BCS); gastrointestinal; intestinal absorption; membrane transport; prodrugs;
Keywords: سیستم طبقه بندی بیولوژیک (BCS); fluconazole; bioequivalence; dissolution; biopharmaceutics classification system (BCS); permeability; solubility; biowaiver; therapeutic index; metabolism; elimination;
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Quality by Design (QbD); bioavailability; biopharmaceutics classification system (BCS); clinical trial simulations; controlled delivery; in silico modeling; in vitro models; in vitro/in vivo correlations (IVIVC); oral drug delivery; pharmacokinetics; phar
Introduction to the OrBiTo decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Dissolution; Decision tree; Formulation; Oral absorption; PBPK; Biopharmaceutics classification system (BCS);
Application of an In Vitro Dissolution/Permeation System to Early Screening of Oral Formulations of Poorly Soluble, Weakly Basic Drugs Containing an Acidic pH-Modifier
Keywords: سیستم طبقه بندی بیولوژیک (BCS); oral absorption; Biopharmaceutics Classification System (BCS); dissolution; permeability; in vitro/in vivo correlations (IVIVC);
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride
Keywords: سیستم طبقه بندی بیولوژیک (BCS); proguanil hydrochloride; absorption; bioequivalence; Biopharmaceutics Classification System (BCS); excipients; permeability; regulatory science; solubility;
Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective
Keywords: سیستم طبقه بندی بیولوژیک (BCS); EU; European Union; MA; marketing authorisation; BE; bioequivalence; BCS; Biopharmaceutics Classification System (BCS); CHMP; Committee for Medicinal Products for Human Use; NHS; National Health System; API; active pharmaceutical ingredient; EMA; European
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate
Keywords: سیستم طبقه بندی بیولوژیک (BCS); amoxicillin trihydrate; biowaiver; Biopharmaceutics Classification System (BCS); permeability; solubility; dissolution;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril
Keywords: سیستم طبقه بندی بیولوژیک (BCS); enalapril maleate; enalaprilat; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility; in situ conversion;
FaSSIF-V3, but not compendial media, appropriately detects differences in the peak and extent of exposure between reference and test formulations of ibuprofen
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Dissolution; Surface pH; Biopharmaceutics Classification System (BCS); Capacity of detection; Biowaiver
Gastrointestinal Behavior of Weakly Acidic BCS Class II Drugs in Man-Case Study of Diclofenac Potassium
Keywords: سیستم طبقه بندی بیولوژیک (BCS); oral drug delivery; biopharmaceutics; clinical pharmacokinetics; gastrointestinal; supersaturation; precipitation; disposition; food effects; drug interaction; Biopharmaceutics Classification System (BCS);
Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid
Keywords: سیستم طبقه بندی بیولوژیک (BCS); quality by design (QbD); bioavailability; Biopharmaceutics Classification System (BCS); clinical trial simulations; drug delivery; in silico modeling; in vitro models; in vitro and in vivo correlations/relationships (IVIVC/R); Biopharmaceutics Risk Assess
The Impact of the EMA Change in Definition of “Dose” on the BCS Dose-Solubility Ratio: A Review of the Biowaiver Monographs
Keywords: سیستم طبقه بندی بیولوژیک (BCS); biopharmaceutics classification system (BCS); bioavailability; bioequivalence; regulatory science;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Codeine Phosphate
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; bioavailability; bioequivalence; biopharmaceutics classification system (BCS); codeine phosphate; permeability; dissolution; solubility;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam
Keywords: سیستم طبقه بندی بیولوژیک (BCS); piroxicam; absorption; biopharmaceutics classification system (BCS); permeability; solubility; dissolution; regulatory science;
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate
Keywords: سیستم طبقه بندی بیولوژیک (BCS); bioequivalence; dissolution; bisoprolol; biopharmaceutics classification system (BCS); permeability; solubility; absorption;
Disposition Kinetics of Diclofenac in the Dual Perfused Rat Liver
Keywords: سیستم طبقه بندی بیولوژیک (BCS); albumin; biopharmaceutics classification system (BCS); disposition; hepatic clearance; pharmacokinetics; protein binding; diclofenac; dual liver perfusion; hepatic artery; portal vein
Evaluation of Rat In Vivo Fetal-to-Maternal Transfer Clearances of Various Xenobiotics by Umbilical Perfusion
Keywords: سیستم طبقه بندی بیولوژیک (BCS); active transport; biopharmaceutics classification system (BCS); drug transport; efflux pumps; placenta; log P; pregnancy; clearance; kinetics
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Efavirenz
Keywords: سیستم طبقه بندی بیولوژیک (BCS); efavirenz; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;
Transepithelial transport of biperiden hydrochloride in Caco-2 cell monolayers
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Biopharmaceutics Classification System (BCS); Caco-2 cells; Permeability; Regulatory science; Biperiden hydrochloride
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Stavudine
Keywords: سیستم طبقه بندی بیولوژیک (BCS); stavudine; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Primaquine Phosphate
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; bioavailability; bioequivalence; Biopharmaceutics Classification System (BCS); permeability; solubility; primaquine phosphate;
Biowaiver Approach for Biopharmaceutics Classification System Class 3 Compound Metformin Hydrochloride Using In Silico Modeling
Keywords: سیستم طبقه بندی بیولوژیک (BCS); oral absorption; Biopharmaceutics Classification System (BCS); mathematical model; dissolution; permeability;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; bioavailability; bioequivalence; Biopharmaceutics Classification System (BCS); quinine; permeability; regulatory science; solubility;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Ketoprofen
Keywords: سیستم طبقه بندی بیولوژیک (BCS); ketoprofen; absorption; Biopharmaceutics Classification System (BCS); permeability; solubility; dissolution; regulatory science;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amodiaquine Hydrochloride
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; amodiaquine; bioavailability; bioequivalence; Biopharmaceutics Classification System (BCS); permeability; dissolution; solubility;
Development and Optimization of SelfâNanoemulsifying Drug Delivery System with Enhanced Bioavailability by Box-Behnken Design and Desirability Function
Keywords: سیستم طبقه بندی بیولوژیک (BCS); Biopharmaceutics Classification System (BCS); flurbiprofen; SNEDDS; Box-Behnken design; desirability function; optimization; solubility; bioavailability; dissolution; particle size;
A Formulation Strategy for Gamma Secretase Inhibitor ELND006, a BCS Class II Compound: Development of a Nanosuspension Formulation with Improved Oral Bioavailability and Reduced Food Effects in Dogs
Keywords: سیستم طبقه بندی بیولوژیک (BCS); oral drug delivery; bioavailability; Biopharmaceutics Classification System (BCS); crystallinity; dissolution; food effects; solubility; pharmacokinetics; particle size; gamma secretase inhibitor; Alzheimer's disease;
Toward the Establishment of Standardized In Vitro Tests for Lipid-Based Formulations, Part 1: Method Parameterization and Comparison of In Vitro Digestion Profiles Across a Range of Representative Formulations
Keywords: سیستم طبقه بندی بیولوژیک (BCS); LFCS Consortium; lipid-based drug delivery systems; SEDDS; drug solubilization; in vitro digestion testing; Solubility; Biopharmaceutics classification system (BCS); Bioavailability; In vitro models; Precipitation
Solution-Mediated Phase Transformation: Significance During Dissolution and Implications for Bioavailability
Keywords: سیستم طبقه بندی بیولوژیک (BCS); amorphous; bioavailability; Biopharmaceutics Classification System (BCS); cocrystals; crystallization; dissolution; polymorph; solubility
Investigation on the Possibility of Biowaivers for Ibuprofen
Keywords: سیستم طبقه بندی بیولوژیک (BCS); bioequivalence; Biopharmaceutics classification system (BCS); dissolution; regulatory science; solubility; permeability; absorption;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levofloxacin
Keywords: سیستم طبقه بندی بیولوژیک (BCS); levofloxacin; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metronidazole
Keywords: سیستم طبقه بندی بیولوژیک (BCS); dissolution; absorption; Biopharmaceutics Classification System (BCS); metronidazole; permeability; regulatory science; solubility;
COMMENTARY: Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Lamivudine
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; bioavailability; bioequivalence; biopharmaceutics classification system (BCS); biowaiver; lamivudine; permeability; solubility;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Mefloquine Hydrochloride
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; bioavailability; bioequivalence; Biopharmaceutics Classification System (BCS); mefloquine hydrochloride; permeability; solubility
Biopharmaceutical Characterization of Ciprofloxacin HCl-Ferrous Sulfate Interaction
Keywords: سیستم طبقه بندی بیولوژیک (BCS); bioavailability; Biopharmaceutics Classification System (BCS); ciprofloxacin HCl; dissolution; drug interaction; in silico modeling; ferrous sulfate; oral absorption; solubility;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ciprofloxacin Hydrochloride
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; biopharmaceutics classification system (BCS); ciprofloxacin; dissolution; permeability; regulatory science; solubility
Development of a new permeability assay using lowâefflux MDCKII cells
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; Pâglycoprotein; ADME; drug transport; in vitro models; bioavailability; LC-MS; Biopharmaceutics Classification System (BCS); cell culture; MDCK cells; transporters;
Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs
Keywords: سیستم طبقه بندی بیولوژیک (BCS); bioequivalence; biopharmaceutics classification system (BCS); dissolution rate; absorption; solubility;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide
Keywords: سیستم طبقه بندی بیولوژیک (BCS); furosemide; absorption; bioequivalence; Biopharmaceutics Classification System (BCS); permeability; solubility; regulatory science;
Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate**
Keywords: سیستم طبقه بندی بیولوژیک (BCS); absorption; biopharmaceutics classification system (BCS); doxycycline hyclate; permeability; regulatory science; solubility;
The Developability Classification System: Application of Biopharmaceutics Concepts to Formulation Development
Keywords: سیستم طبقه بندی بیولوژیک (BCS); biopharmaceutics classification system (BCS); bioequivalence; oral absorption; developability; biorelevant media; solubility; permeability; dissolution rate;