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Track 1: Advances in Discovery, Formulation, and Delivery of New Modalities
(T1030-01-01) Development of Physicochemical Profiling Platform for Therapeutic Oligonucleotides
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(W1030-01-01) Development of Physicochemical Profiling Platform for Therapeutic Oligonucleotides III Thermodynamic Analysis on Higher-Order Structure of Oligonucleotides
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(T1030-01-02) Demonstrating the Excipient Effect In Vitro for Pre-clinical Formulation Analysis
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(W1030-01-02) Potential Biomedical Applications of Silver Nanoparticles Synthesized Using Anisotes trisulcus Extract from Saudi Arabia: Antioxidant, Antibacterial, and Anti-Proliferative Properties
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(W1030-01-03) Oral Delivery of Remdesivir Analogues: Alternatives for Intravenous Remdesivir with Reduced Potential Drug-Drug Interactions
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(T1030-01-03) Stability of Therapeutic Monoclonal Antibodies during Infusion with Elastomeric Pumps Intended for Home-Based Therapy
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(W1030-01-04) Preparation and Scale-Up of Liposomal Amphotericin B Formulation and a Comparison with Commercially Available Counterpart, Ambisome®
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(T1030-01-05) Flash Nanoprecipitation Permits Self-assembly of Ionizable Lipid Nanoparticles for Nucleic Acid Delivery
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(T1030-02-06) A Mechanistic Model of IgG4-RD Identifies High-Potential Therapy Targets
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(W1030-02-06) Antibody Synthesis in Cell-Free for High-Throughput Production and Screening
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(T1030-02-07) Analytical Method Validation Strategy for Determination of Charge Heterogeneity of Antibody Therapeutics Using Reference Material Comparison as an Alternative to Spiking Studies
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(W1030-02-07) Comparative Analyses of Thermal Stability Amplifying Peptide Dendrons and Polysorbates
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(W1030-02-08) Optimization of Artificial Colonic Mucus for Drug Diffusion Study
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(T1030-02-08) Single Cell Gel Electrophoresis to Detect Genotoxicity of Iminostilbene, a Process Induced Impurity of Carbamazepine
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(W1030-02-09) Design and Evaluation of a Cyclic Peptide-Epirubicin Conjugate to Enhance Anticancer Activity and Reduce Cardiac Toxicity
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(T1030-02-09) Evaluating the Effects of Differently Charged Linker-Drugs on Pharmacokinetics and Tissue Distribution of Antibody Drug Conjugates
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(W1030-02-10) Delivery of Carbonic Anhydrase 9 siRNA by Lipid Nanoparticles
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(T1030-02-10) Synthesis a Cationic-Polymer Incorporating Carboxylesterase Active Ester for the Delivery of CRISPR/Cas9 to Ameliorate Hyperlipidemia
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(W1030-02-11) Machine Learning Approaches to Analysis of Microscopy Images of Polysorbate Degradation Product Particles
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(T1030-02-11) The Importance of Orthogonal Methods for the Determination of the Size Distribution of Lipid Nanoparticles
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(W1230-01-01) Development of Physicochemical Profiling Platform for Therapeutic Oligonucleotides IV Evaluation of Compactness of Oligonucleotides for Determining Their Higher-Order Structure
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(T1230-01-01) Parallel-Competitive Absorption Metabolism Model for Calculation of Subcutaneous Bioavailability of Monoclonal Antibodies
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(W1230-01-02) Impact of Amino Acids as Excipients in Biologic Drug Products Formulation Development
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(T1230-01-04) Iontophoretic Transdermal Delivery of a Bioactive Molecule: Comparison of Nanoliposomal Platforms with Passive Delivery
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(W1230-01-05) Development of a Marburg Self-amplifying mRNA-Lipid Nanoparticle Vaccine: Differential Effects When Co-formulated with Toll Receptor Agonists
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(T1230-01-05) Development of Inhalable Polymeric Nanoemulsions for Delivery of Gene Silencing Therapeutics in Lung Tumors
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(T1330-01-01) Development of Physicochemical Profiling Platform for Therapeutic Oligonucleotides II Circular Dichroism Spectroscopy and Nuclear Magnetic Resonance Analysis for Determining Higher-Order Structure
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(W1330-01-01) Stabilization of Viruses for Vaccines and Gene Therapy by Spray Drying and Lyophilization
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(T1330-01-02) Formulation Development and Characterization of a Marburg Self-amplifying mRNA-Lipid Nanoparticle Vaccine with a Toll-Like Receptor 7 Agonist
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(W1330-01-02) Poloxamer 188 and Propylene Glycol Loaded with Novel Pyridine-Based 1,2,4-Triazolo-Tethered Indole Conjugate as Rectal Suppository to Treat Colorectal Cancer
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(W1330-01-03) Deciphering the Role of Hydrogel Network Topology in Programmably Degradable Hydrogels
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(T1330-01-03) Stain-Free Approach to Determine and Monitor Cell Heath Using Supervised and Unsupervised Image-Based Deep Learning
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(T1330-01-04) Predicting the Aggregation Behavior of Liposomes Using Thermal Analysis
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(W1330-01-04) Prolonged Ocular Delivery of Sunitinib from Poly (diol-tricarballylate) Injectable Biodegradable Elastomeric Tiny Implant for Diabetic Retinopathy Treatment
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(W1330-01-05) Extrapolating the Use of Microfluidic Chips to Formulate Reproducible and Effective Nanoemulsions for Subunit Vaccines: A Paradigm Shift in Manufacturing Emulsion Adjuvants
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(T1330-01-05) Optimizing Lipid Nanoparticles (LNPs) Processing for siRNA Delivery by Microfluidics System
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(W1430-01-01) Development of Physicochemical Profiling Platform for Therapeutic Oligonucleotides V Biological Function Analysis of Oligodeoxynucleotides
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(T1430-01-01) Static Light Scattering Signatures Used to Identify and Minimize Aggregation During Formulation Development
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(W1430-01-02) High Concentration Protein Suspensions: A Case Study for Subcutaneous Delivery of Bevacizumab
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(T1430-01-03) Val-His-Ser (VHS) N-terminal Leader Sequence and Implications for mAb Subcutaneous Pharmacokinetics
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(W1430-01-04) Innovative Device for Concomitant Therapeutic Compound Delivery into the Brain and Neural Recordings - Feasibility Bench and In Vivo Studies
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(T1430-01-04) Ionizable Lipid Nanoparticles for Dual siRNA/Chemotherapy Delivery for B-cell ALL Treatment
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(W1430-01-05) Characterization of Protein Antigens in Liposomal Vaccines Using Differential Scanning Fluorimetry
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(T1530-02-11) Formulation Development and Characterization of a Marburg Self-amplifying mRNA-Lipid Nanoparticle Vaccine with CpG Oligonucleotide
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(W1230-01-03) Elastin-Like Polypeptide (ELP) Antibody Fusions Targeting IL-6: Pharmacology and Pharmacokinetics
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Track 2: Novel Strategies to Advance Biotherapeutic Development
(T1130-02-06) Biodistribution Analysis of GPC-3 CAR-T Cells in NSG Mice by a Universal ddPCR Assay to Support an IND-Enabling Toxicity Study
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(W1130-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (2) Oxidation
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(T1130-02-07) Anti-CCR8 Mediated Depletion of Tumor-Infiltrating Regulatory T Cells: Preclinical PK/PD and Translational Strategy in Support of Clinical Development for Solid Tumor Indications
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(W1130-02-07) Biodistribution Study of a Bivalent SARS-CoV-2 mRNA Vaccine in Rat
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(T1130-02-08) Intestinal Organoid as a Predictive Model for the Assessment of Nano-Drug Delivery Systems
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(W1130-02-08) Oral Absorption of Semaglutide: Pharmacokinetic Modeling and Molecular Dynamics Simulations
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(W1130-02-09) Immunogenicity Risk Assessment of Salmon Calcitonin Peptide Impurities Using In Silico and In Vitro Methods
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(T1130-02-10) A Novel Approach to Mechanical Characterization of Pharmaceutical Lyospheres
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(W1130-02-10) Choosing the Right Bioanalytical Platform to Accommodate a Biotherapeutic Pharmacokinetic Measurement in Serum and CSF: A Case Study
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(W1130-02-11) Comparison of a Microfluidic Generic Total Antibody (TAb) Assay with Independent Neutralizing Antibody (NAb) and TAb Assays for the Detection of Pre-existing Antibodies against AAV Vectors
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(T1130-02-11) Rapid and Predictive Immunogenicity Risk Assessments Using In Silico Methods
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(T1230-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Overview
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(W1230-02-06) Strategies for the Development and Characterization of Sensitive Anti-oligonucleotide Antibodies for Application in Anti-drug Antibody Assays
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(T1230-02-07) A Validated Immunocapture LC-MS/MS Hybrid Assay for the Quantitation of a Novel Multi-Domain Therapeutic Protein in Human Plasma with Clinical Sample Analysis
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(W1230-02-07) Docetaxel and QDs Based Nano Lipidic Theragnostic System for Cure and Real-Time Monitoring of Breast Cancer: Efficacy and Safety Studies in Rats
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(T1230-02-08) Quantitation of Soluble Tumor-Associated Antigens (sTAA) in Tumor Interstitial Fluid (TIF) Isolated from Frozen Solid Tumors
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(W1230-02-09) LC-MS FFPE Tissue Analysis Across Multiple Murine Tissues Supports Mouse Relevance for On-Target/Off-Tumor Toxicity Assessment for Anti-STEAP2 CAR-T Therapeutic Development
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(T1230-02-09) Population Pharmacokinetics and Exposure-Efficacy and -Safety Analyses of Atezolizumab for Subcutaneous Injection in Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer
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(T1230-02-10) Development of a Highly Sensitive Immunoassay to Measure Circulating Levels of a Nanobody-Based Imaging Agent
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(W1230-02-10) Qualification of a 48-plex Cytokine Olink Panel to Support Rare Disease and Pediatric Clinical Studies
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(W1230-02-11) Comprehensive Assessment of Immunogenicity Risk of Host Cell Proteins in Biologics and Vaccines Using In Silico and In Vitro Methods
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(T1230-02-11) Sensitive Quantitation of Antisense Oligonucleotides Using Capitainer
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qDBS Microsampling Device Coupled with Hybridization LC-MS/MS
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(W1330-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (1) Deamidation
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(T1330-02-06) Utilizing a Bead-Based Sample Pretreatment to Overcome Drug Interference in Developing a Ligand Binding Neutralizing Antibody Assay
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(T1330-02-07) Optimizing and Validating an In Vitro Transcytosis Assay for Predicting Pharmacokinetics in Drug Discovery and Process Development
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(T1330-02-08) Production and Characterization of Critical Biotin and DIG Conjugated RESCA-Anti-CD8 VHH Reagents to Enable the Non-Clinical and Clinical Anti-Drug Antibody Assay Development
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(W1330-02-09) Using Cryo-TEM to Characterize Structural Details of LNPs during Manufacturing
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(W1330-02-10) Next-Generation Biocompatible HPLC System for Enhanced Analysis of Biotherapeutics
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(T1330-02-10) Novel Immunoassay Technology: Evaluating the PIXI Platform for Rapid Quantitation with Automation, Wide Dynamic Range, and Small Sample Volume Requirement
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(T1330-02-11) Oligonucleotide Dual Hybridization Assay Using Offline Pre-incubation followed by an Automated Microfluidic Method
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(W1330-02-11) One Drop of Blood, Multiple Sets of Data --- Establishing A Common Protocol for Serotype Specific IGG Concentration Testing Using Mitra® VAMS Dry Blood Samples to Support Vaccine Clinical Studies
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(W1430-02-06) Application of a Novel Affinity Purified Chicken IgY in an Immunoaffinity LC-MS/MS Assay for Rapid Quantitation of Monoclonal Antibody Therapeutics and ADCs in Nonclinical Species
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(T1430-02-06) Interlaboratory Study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (1) C-terminal Lys Clipping
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(T1430-02-07) Analysis of Glucagon-Like Peptide-1 (GLP-1) Analog in Rat Plasma Using an LC-MS/MS Workflow
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(W1430-02-07) Novel Use of Recombinant Dimeric IgA Monoclonal Antibodies as Cyst-Targeted Therapeutics in Polycystic Kidney Disease
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(W1430-02-08) In Vitro Method Using Circulating Tumor Cells-Derived Organoids from Patients with Solid Tumors to Transform Oncology Drug Development
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(T1430-02-08) Leveraging Buprenorphine as a Tool Molecule to Develop a Novel PBPK Model Accounting for Intestinal Lymphatic Absorption
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(T1430-02-09) Bridging Bevacizumab PK from Adults to Pediatrics through PBPK Modeling
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(W1430-02-09) Exploring the Future Potentials of High-Resolution Mass Spectrometry for Regulated Bioanalysis
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(T1430-02-10) A Novel In Vitro Serum Stability Assay for Antibody Therapeutics Incorporating Internal Standards
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(W1430-02-10) Analysis of Anti-Drug Antibodies (ADA) in Multiple Animal Species from mRNA LNP Therapeutics Supporting Rare Diseases Demonstrated Low Immunogenicity of PEG-2000 by ECLA and ELISA Methodology
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(W1530-02-06) Age-Dependent Reduction in Hepatic Vector Genome Loss in Juvenile OTC
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Mice Following a Single Dose of DTX301 and Partial Compensation Achieved with a Higher Dose
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(T1530-02-06) Development of an Electrochemiluminescent Assay for the Detection of Anti-PEG IgE Antibodies in Human Serum
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(T1530-02-07) Integrated HypoSkin® Model and PBPK Modeling as a Bioavailability Predicting Tool for Subcutaneous Delivery of Protein Therapeutics
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(T1530-02-08) Cross Validation of Pharmacokinetic Assays: Experimental and Statistical Design
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(W1530-02-08) Non-invasive Molecular Imaging of V3 Receptors to Localize ACTH-Dependent Cushing's Syndrome and Precision Surgery of Corticotropinoma
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(W1530-02-09) Development of Non-Cell Based Potency Assays for Bispecific Antibodies
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(T1530-02-09) False Positive or Not? – Assessing Potential Interference of Soluble Target to ADA Detection for a Clinical Stage Program
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(W1530-02-10) An “I” (Immunogenicity Risk Assessment) for an Eye (Ophthalmology Biologics)
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(T1530-02-10) Development of a Generic, Automated, Microfluidic Human IgG-FcRn Affinity Assay In-Solution for Use in Antibody Engineering
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(W1530-02-11) Evaluation of API 7500 Integrated System with Microflow LC System M5 Using Sulfamethazine (SDX) Neat Solution
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(T1130-02-09) Evaluation of Sample Preparation Techniques for Protein Quantification
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(W1330-02-07) Enhancing Antibody Detection for PABAD-Based Neutralizing Antibody Detection and Validation
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(T1330-02-09) Gyrolab Generic Anti-drug Antibody Assay Streamlines Preclinical Immunogenicity Assessment
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(T1430-01-02) Enhanced Transdermal Delivery of Anticancer Agent: A Comprehensive Study on Fractional Ablative Laser
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