Manufacturing and Analytical Characterization - Chemical

(W0930-08-49) Study and Characterization of Polyurethane Mixtures to be Employed in Direct Powder Extrusion Using Expert Systems

(M0930-08-50) Design, Development, and Evaluation of Novel Extended-Release Liposomal Topical Cream Formulation of Pregabalin Using Microemulsion Technique for the Treatment of Local Neuropathic Pain

(W0930-08-50) Impact of Hot Melt Extrusion Processing on Amorphous Solid Dispersion Bulk Powder Properties

(W0930-08-51) Linking 3DP Manufacturing with SIFT-MS Volatiles Organic Compound Analysis

(M0930-08-51) Peak Shear and the Effect of Kneading Block Geometries on Twin Screw Granulation Process Design

(W0930-08-52) Method Development for the Evaluation of Orally Inhaled Drug Products (OIDPs) containing Spray-Dried Phospholipid Porous Particles (PPPs)

(M0930-08-53) Advancements in Mini-Tablets: High Drug Loading and Precise Dose Titration

(W0930-08-53) Assessment of Laser Directed Infrared Imaging for In Vitro Characterization of Pharmaceutical Tablets

(W0930-08-54) Synchrotron X-Ray Diffraction of the Structure of Amorphous Indomethacin Using PDF Analysis and EPSR Modeling

(M0930-08-54) Use of Granulation and E-Tongue for Taste-Masking of an Orally Disintegrating Tablet (ODT)

(W0930-08-55) Distributed Manufacturing of 3D Printed Pharmaceuticals: A Case Study

(M0930-08-55) Worsened Punch Sticking by External Lubrication with Magnesium Stearate

(W0930-09-57) New Insights into Non-classical Crystallization of Pharmaceutical Solids: Chemically-Specific Coherent Raman Imaging of Liquid-Liquid Phase Separation

(W0930-09-58) Continuous Wet Granulation and Drying: Moving from Technical Feasibility to Commercial Scale

(T0930-09-58) Crystallization Kinetics of Amorphous Lactose: The Difference between α and β Anomers

(M0930-09-58) Screening Chiral Stationary Phases in Multiple Separation Modes to Identify a Method for the Enantiomeric Separation of Modafinil

(T0930-09-59) Analysis of Semi- and Non-Volatile Leachables via an Enhanced HPLC-UV Method

(M0930-09-59) CryoTEM Imaging of Onivyde for Precise Reverse Manufacturing

(W0930-09-59) Pneumatic Aerosolization of the Surrogate Acetaminophen in a Newly Developed Chamber Setup for Containment Investigations with Special Focus on Spatial Dust Distribution

(T0930-09-60) Development, Optimization and Validation of UPLC Method for Determination of Flavonoids from Seed Extracts of Elite Pongamia pinnata

(W0930-09-60) Mitigation of Tribocharging in Pharmaceutical Powders Using Surface Modified V-Blenders

(M0930-09-60) Terahertz Pulsed Imaging (TPI) Based Liquid Transport Profiling For the Tablet Disintegration Process Analysis

(M0930-09-61) Scale-Down Modeling of the Filling Process for Protein-Based Parenteral Drug Products

(W0930-09-61) Visualising Co-crystal Formation during Milling with Stimulated Raman Scattering (SRS)

(M0930-09-62) A Tactic for Resolving Lactose Matrix Interference with Residual Heptane in GC Analysis of an API cPAD Formulation

(T0930-09-62) An Improved Spray Dried Dispersion Model: Integrating Machine Learning to Predict Optimized Process Parameters

(M1030-08-49) Automated Workflow to Study Microsomal Clearance and Analysis of Metabolites Using Collision-Induced Dissociation and Electron-Activated Dissociation

(T1030-08-49) Leveraging Automation to Develop a Robust High Throughput Thermodynamic Solubility Assay Using Neat Drug Powder

(W1030-08-50) Development of a Gel Filtration Chromatography Method for Polyglutamic Acid in a Semisolid Dosage Form

(W1030-08-51) Microdosing with Vibrating Capillary – Influence of Dosing Time on Precision

(M1030-08-52) AQbD Method Development for a Venlafaxine Extended-Release Tablets Organic Impurities Procedure

(T1030-08-53) Impact of Microcrystalline Cellulose Grade and Vibrational Feeding Assistance on Loss-in-Weight Continuous Feeding

(W1030-08-53) Optimized HPLC Method for the Lacosamide and Its Impurities in the Lacosamide Injection

(T1030-08-54) Addressing Particulate Matter in Protein Therapeutics

(M1030-08-54) Benefits of the Structure-Data File (SD File) Format for Knowledge Aided Structured Assessment (KASA) and Cheminformatics in FDA

(M1030-08-55) Correlating Tablet Performance Differences to Tablet Microstructure Via MFV-SEM and XRM Imaging Coupled with AI Image Analytics

(W1030-09-57) Development, Qualification, and Application of an LC-CAD-MS Method for Determination of Lipid Content in an RNA-LNP Drug Product Containing Novel Lipids with Diverse Physiochemical Properties

(T1030-09-57) Evaluating the Potential of X-Ray Microscopy (XRM) as a Non-destructive Technique for the Characterization of Dry Powder Inhaler (DPI) Formulations

(W1030-09-58) Challenges in Nitrosamine Determination for Pharmaceutical Products: An Analytical Perspective

(T1030-09-58) Comparing the Performance of Wet and Dry Polymer Binders in High Shear Wet Granulation and Twin-Screw Granulation Processes

(M1030-09-58) Effects of Tableting Speed, Blending Time, and Feed Frame Shear Sensitivity on Tablet Properties

(W1030-09-59) A Novel High Speed NIR Sensor as a PAT Tool for Monitoring of the Tableting Process: Determination of the Effective Sampling Depth

(T1030-09-59) Development of a Fast and Robust LC-MS/MS Method for Simultaneous Analysis of a Wide Range of Antibiotics: A Cost-Effective Solution for Pharmaceuticals

(M1030-09-60) A Material Sparing Approach for Predicting Ribbon Solid Fraction at Diverse Roll Compaction Speeds

(T1030-09-60) Investigation into How Solvent Selection Affects the Metastable Zone of Paracetamol During a Thermally Controlled Recrystallisation

(W1030-09-60) Sensory Panel Tests for Topical Semi-solid Gels: Role of Critical Quality Attributes in Predicting Sensorial Perceptions

(T1030-09-61) A Novel Method for Coating of Fine Particles to Time-Saving

(M1030-09-61) Characterization of Stress Induced Amorphous Phase Formation during Tableting Detected by Solid-State NMR – Implications on Stability and Formulation Selection

(M1030-09-62) Crystallization and Unique Crystal Structures of the Clinical Cyclic Peptide LUNA18

(T1030-09-62) Interconversion Kinetic Study to Assess Class II Atropisomeric Drug Development Challenges

(T1130-08-49) Excipient Characterization: Solid Density and Surface Area

(W1130-08-49) In Line Particle Size Detection in Roll Compaction

(M1130-08-51) Comparative Study of Suitability for Wet Continuous Production Process Using MCC with Different Characteristics

(W1130-08-51) Impact of Microcrystalline Cellulose Particle Size Grade on Loss-in-Weight Continuous Feeding

(T1130-08-51) Multivariate Analysis of Granule Size Data from Continuous Granulation Screening and Response Surface Studies: A Tool for Process Understanding

(W1130-08-52) Development of Nano Albumin Bound (nab) Paclitaxel Using Scalable High Shear Processing Technology and Comparison of Plasma-Derived and Recombinant Human Serum Albumin

(T1130-08-52) Effect of Packing Fraction on Permeability of Powders for Pharmaceutical Processes

(M1130-08-52) Enabling Formulation Development of LAIs Thorough Understanding Critical Formulation Parameters

(M1130-08-53) Investigation of Non-specific Adsorption of Lipid Components of the Emulsion-Based Formulations Stored in Glass Vials

(T1130-08-53) Microfluidic-Assisted Preparation of ARV 825 and Osimertinib Loaded Liposomal Formulation as a Potential System for Colorectal Cancer Therapy

(M1130-08-54) Mitigation Strategies to Reduce the Risk of the N-nitrosamine Impurity in Drug Products

(M1130-08-55) Effects of SDS Quality and Dissolution Medium Warm-Up Time on Dissolution Release of MRTX849 IR Tablets, 200 mg

(T1130-08-55) Monolayer Tablet Compression Process Optimization Using a Response Surface Method Design of Experiments

(T1130-09-56) Impact of Relative Humidity on the Flow Behaviour of Pharmaceutical Materials during Powder Feeding

(W1130-09-57) Re-Development of a Fit-for-Purpose Assay Degradation HPLC Method Using Open Lab Software

(T1130-09-58) Investigation of Formulation of Mini-tablets with Direct Compressible Excipients

(M1130-09-58) NTA Analysis: Linear Range Evaluation for Exosomes

(W1130-09-58) Qualitative and Quantitative Analysis of Lipids in Exparel ^® Injectable Liposomal Drug Formulation

(T1130-09-59) Nitroso Drug Substances Related Impurities Analysis in Active Pharmaceutical Ingredients

(W1130-09-59) Predicting Tablet Cascade of ConsiGma Continuous Coater Using Discrete-Element-Method (DEM) Simulations

(T1130-09-60) A Study on the Modernization of Analytical Methods in Korean Pharmacopoeia

(W1130-09-60) Temporal Dominance Sensations (TDS) for Topical Skin Products

(M1130-09-60) Use of Robotics and 3D Printing to Assess In Vitro Adhesive Tack Testing of Transdermal Patches

(M1130-09-61) Biofouling Assessment of Zwitterionised Superhydrophilic Polyvinyl Alcohol Hydrogels using E. coli and S. aureus

(W1130-09-61) Low Dose Formulations in Continuous Manufacturing of Tablets via Semi-continuous Feeding and Blending

(T1130-09-61) Reliable HPLC Method for the Simultaneous Determination of Aspirin and Associated Related Substances in Drug Substance and Tablet Formulation

(M1130-09-62) A Continuous Future: Demonstrating Proof of Concept for Continuous Post-Drying of Pharmaceutical Spray Dried Intermediates

(T1130-09-62) Manufacture of Low-Dose Rapidly Disintegrating Dosages Using 3DP Binder Jetting

(M1230-08-49) Physical Evaluation of a Late Appearing Polymorph of Ritonavir Form III

(T1230-08-50) Strength Evaluation of Pharmaceuticals and PTP Packaging

(T1230-08-51) Common Deficiencies with Spray Dried Dispersion Intermediates for Solid Oral Drug Products Assessed by the FDA

(M1230-08-51) Elucidating the Effect of Processing Temperature and Acid Hydrolysis on Molecular Weight Distribution of Carrageenan

(M1230-08-52) Quality Assessment of Polysorbates 80 and 20 Pharmaceutical Raw Materials by Measuring Fatty Acids Composition using HPLC with Mass Detection

(M1230-08-53) An Investigation of Robust Sample Preparation on an Automated Tablet Processing Workstation, and Lessons Learned

(T1230-08-53) Application of 3D Printing Technology for Development of Dose Adjustable Geriatric and Pediatric Formulation of Celecoxib

(T1230-08-54) Development of 3D-Printed Bicompartmental Tablets by Dual Fused Deposition Modelling (FDM) for Site-Specific Colon Drug Delivery

(M1230-08-54) Optimizing Medication Regimens with Robo-Pharmacist: A Cost-Effective Approach to Reduce Polypharmacy and Improve Adherence

(T1230-08-55) Long-Term Stability of In-House Sunscreen Formulations

(M1230-09-56) Trace Level Quantification of Nitrosamine Impurities in Tuberculosis Medicines by LC-MS/MS

(T1230-09-57) Analytical Quality by Design Based Method Development for the Analysis of Cold and Cough Formulations

(T1230-09-58) Systematic Method Development of Deferoxamine Mesylate Forced Degradation Sample

(T1230-09-59) A Continuous Twin Screw Melt Granulation Process for High Drug Loading Oral Dosage Formulation

(M1230-09-59) Artificial Intelligence Based Particle Characterization for Predictive Insight of Drug Product Quality and Performance

(M1230-09-60) Advantage and Challenges of PROTAC Research, Development and Manufacturing

(T1230-09-60) Improved Biopharmaceutical Peptide Mapping Workflows Using a Novel Autolysis-Resistant Trypsin Enzyme

(T1230-09-61) Optimization of the Continuous Direct Compression Process with Special Focus on Filling Devices

(M1230-09-61) Predicting Granule and Tablet Properties Using In-Line Measurements and Evolutionary Equation Discovery

(M1230-09-62) Detecting Low-Level Crystallinity in ASD-Like Samples Using SSNMR Techniques

(T1230-09-62) Enhanced Mechanistic Understanding of Drug Product Performance Via High-Resolution Imaging and AI Image Analytics

(T1330-08-50) Tailoring Drug Release from Long-Acting Contraceptive Levonorgestrel-Containing Intrauterine Systems

(M1330-08-50) The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method

(M1330-08-51) Moisture Activated Dry Granulation: A Sustainable Process with Excipients and Process Consideration

(T1330-08-51) Polarized Light Microscopy: A Versatile Technique in the Reverse Engineering of Entacapone Tablets

(T1330-08-52) Development of a Discrete Element Method (DEM) Model to Study the Impact of Process Parameters and Material Attributes on Continuous Twin Screw Wet Granulation Process

(M1330-08-52) Optimization of USP Method for Quantitation of Beta Glucan Using a High-Performance Liquid Chromatography and Adapting to a Low Strength Semisolid Dosage Form

(M1330-08-53) Better Together: Thermally Unstable Drug Granulated Using a Thermal Process?

(T1330-08-53) Personalized Orodispersible Films Using Extrusion 3D-Printing: An Impending Shift in Pharmaceutical Manufacturing

(M1330-08-54) Amorphous Solid Dispersion Physical Stability: Historical Examples and Shelf-Life Assessment

(T1330-08-54) Do the pH-Stage Dissolution Tests Lie? Case Study of Duloxetine Hydrochloride Dissolution in the Small-Scale Setup

(T1330-08-55) Novel Preparation Method of Spherical Drug-Containing Particles Using High Shear Melt Granulation; MALCORE®

(M1330-08-55) Understanding Release Mechanism and Development of Accelerated Release Tests for Long-Term Intrauterine Systems

(T1330-09-57) Simultaneous Determination of Naphazoline Hydrochloride and Pheniramine Maleate Along with Their Related Compounds by High Performance Liquid Chromatography

(M1330-09-58) Impact of Alternative Lubricants on Tablet Parameters Approaching the Over-Lubrication Problems in Continuous Direct Compression Processes

(T1330-09-58) Principle Component Analysis of Formulation Variations on Binder Jet 3D Printed Tablet

(T1330-09-59) An Improved Multiple Headspace Extraction Workflow Using SIFT-MS

(M1330-09-59) Development of Iterative Optimization Technology Algorithms with a Small-Scale Feed Frame Simulator: Stagnant vs. Dynamic Pure Component Spectra

(M1330-09-60) Compendial Strategy to Define Composition and Quality of Polysorbates

(T1330-09-60) Performance of Pre-Filled Syringe Systems at Low Temperature

(T1330-09-61) 3D Printed Medication: A Case Study on Personalization of Pediatric Arrhythmia Treatment

(M1330-09-61) Demonstration of MicroCoat^TM Scalability: A Fixed Dose Combination of Taste Masked Artesunate-Amodiaquine Micropellets for Malaria Treatment in Paediatrics

(M1330-09-62) A Twin-Screw Melt Coating and Granulation Approach for High Dose Formulations with any Desired Release Profile

(T1330-09-62) Mechanistic Determination of Tensile Strength of Shaped Tablets

(T1430-08-49) 3D Printing of Single and Multi-unit Containers for Dispensing Solid Dosage Forms

(M1430-08-49) An In Vitro Model for Acetaminophen Dissolution from Overdosed Oral Formulations

(T1430-08-50) Analytical Case Studies for Processed-Induced and API-Related Nitrosamines in Finished Drug Products

(M1430-08-50) Leachable Analysis of Ethylene Vinyl Acetate Infusion Bags by GC-FID-MS and LC-UV-MS

(M1430-08-51) Co-processing PVP with Maltodextrin during Spay-Drying Reduces the Impact of Humid Weather on Product Attributes

(T1430-08-52) Application of Twin-Screw Extrusion for Generating Polymorphs to Support Phase Mapping and Scale Up Crystallization of the Desired Form

(M1430-08-52) Systematic Root Cause Analysis for Investigation of Contamination Peak in an Ovicidal Topical Product

(T1430-08-53) Getting Sticky with It – Formulation Tenacity in 3D Printing

(M1430-08-53) Process Analytical Technology for Inline Aerodynamic Particle Size Measurements during Spray Drying

(M1430-08-54) Analysis of Manufacturing Deficiencies for Immediate Release Tablets in Abbreviated New Drug Applications

(T1430-08-54) Determining the Effect of Blade Fouling on the Approach to Steady State and Final Residence Mass within a Continuous Blender

(M1430-08-55) Quantitative Determination of Microcrystalline Cellulose in Drug Products by Chemometrics Analysis of Raman Spectroscopy

(T1430-09-57) Driving Timely Clinical Development: Simulation-Based Process Development and Tech-Transfer for Mini-Tablets in Capsules

(T1430-09-58) Compaction Simulation of SDI-Based Formulations to Enable Material-, Time-, and Cost-Sparing Technical Transfer

(M1430-09-58) Improvements to PS80 Detection in Drug Product Formulations: A Mixed Mode High-Performance Liquid Chromatography Method for the Quantification and Improvement in the Detection of Polysorbates

(M1430-09-59) Electrophotographic 3D Printing of Pharmaceutical Films

(T1430-09-59) Regulatory Experience with Continuous Manufacturing and Real Time Release Testing for Dissolution in New Drug Applications

(T1430-09-60) 2D-LC as A Novel Analytical Platform for the Characterization of Complex Drug Substances: A Case Study with Glatiramer Acetate

(M1430-09-60) Assessing Stress-Induced Amorphization and Excipient Functionality in Tablet Matrices Using Correlative Microscopy Analysis

(T1430-09-61) Identification of Levofloxacin Hydrates and Observation of Their Crystal-Form Transition in Drug Products by Terahertz Frequency-Domain Spectroscopy

(M1430-09-61) Improvement upon a Multi-residue Method for Nitrosamine Analysis in Losartan Drug Product Using an Enhanced LC/MS/MS System

(T1430-09-62) Characterization of Intravenous Iron Supplements: Injectafer^®

(M1430-09-62) Strategies for Data Treatment of RTD Curves for Pharmaceutical Applications

(T1530-08-51) Effect of Morphologies and Process Parameters on Aerodynamic Performance of Fluticasone Propionate in Dry Powder Inhaler

(T1530-08-52) Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach

(T1530-08-54) Critical Formulation Attributes of Naloxone Nasal Spray Products Affecting Nasal Permeation

(T1530-08-55) Investigation Study of Color Change in Drug Tablets by Raman Spectroscopy

(M1530-09-56) Navigating Thermal Binder Selection for Rational Design of a Twin-Screw Melt Granulation Process

(T1530-09-57) An Automated Process Analytical Interface to Estimate Tablet Porosity and Height Based on Terahertz Time-Domain Spectroscopy Reflection Measurements

(T1530-09-58) Exploring Applications of Plant-Derived Polymers in Fused Deposition Modeling of Oral Pharmaceutical Tablets

(T1530-09-59) Development of the Quantitative Prediction Model by Applying Chemometric and Artificial Intelligence in the Near-Infrared Spectrum as Pharmaceutical Process Analytical Technology

(M1530-09-60) Doxorubicin HCl Release from Liposomal Doxorubicin Formulations – Autonomous Capillary Electrophoretic (CE) In Vitro Release Test (IVRT) Method

(T1530-09-60) Impact of Vacuum Drum Filling Parameters on Dry Powder Inhaler Performance

(T1530-09-61) Effect of Collagen Source on the In Vitro Performance of Collagen Implant

(M1530-09-62) Quantitation of Ethylene Oxide and Nitrosamines in Excipients and Pharmaceutical Products Using SIFT-MS

(M0930-08-52) Modern Liquid Chromatographic Gradient Method Allowances Provided by General Chapter, USP Chromatography < 621 >

(T1030-08-51) Development and Validation of Discriminatory Release Method for Intramammary Drug Products as a Part of In Vitro Quality Metrics