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Drug Discovery 1 Introduction: Drug Discovery in the 21st Century 2 Natural Products 3 Cancer Cell Proteomics using Molecular Aptamers 4 Molecular Similarity Methods and QSAR Models As Tools for Virtual Screening 5 Systems Biology: Applications in Drug Discovery 6 High-Throughput Flow Cytometry 7 Combining NMR Spectral Information with Associated Structural Features to form Computationally Nonintensive, Rugged, and Objective Models of Biological Activity 8 Using Microsoft Excel® as a Laboratory Data Management Tool 9 Age of Regulation 10 Simultaneous Screening of Multiple Cell Lines Using the CellCard System 11 Protein X-Ray Crystallography in Drug Discovery 12 Biological and Chemistry Assays Available During Drug Discovery And Developability Assessment 13 Strategies and Methods in Monitoring and Targeting Protein–Protein Interactions 14 High-Throughput Screening: Evolution of Technology and Methods 15 Metal-Enhanced Fluorescence: Application to High-Throughput Screening and Drug Discovery 16 Methods for the Design and Analysis of Replicate-Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays 17 Coupled Luminescent Methods in Drug Discovery: 3-min Assays for Cytotoxicity and Phosphatase Activity 18 Design and Pharmaceutical Applications of Prodrugs 19 GABA and Glutamate Receptor Ligands and their Therapeutic Potential in CNS Disorders 20 Cardiac Sarcolemmal ATP-Sensitive Potassium Channel Antagonists: Novel Ischemia-Selective Antiarrhythmic Agents 21 Factors Influencing the Efficacy of Mediator-Specific Anti-Inflammatory, Glucocorticoid, and Anticoagulant Therapies for Sepsis 22 Combinatorial Chemistry in the Drug Discovery Process 23 Herbal Medicines and Animal Models of Gastrointestinal Diseases 24 Endocrine and Metabolic Agents 25 Respiratory Viruses 26 Strategies in the Design of Antiviral Drugs 27 Protein Kinase Inhibitors in Drug Discovery 28 RNA-Based Therapies 29 Novel Imaging Agents for Molecular MR Imaging of Cancer 30 Targets and Approaches for Cancer Drug Discovery Preclinical Development: ADME and Biopharmaceutical Properties 1 Modeling and Informatics in Drug Design 2 Computer Techniques: Identifying Similarities Between Small Molecules 3 Protein–Protein Interactions 4 Method Development for Preclinical Bioanalytical Support 5 Analytical Chemistry Methods: Developments and Validation 6 Chemical and Physical Characterizations of Potential New Chemical Entity 7 Permeability Assessment 8 How and Where are Drugs Absorbed? 9 Absorption of Drugs after Oral Administration 10 Distribution: Movement of Drugs through the Body 11 The Blood – Brain Barrier and its Effect on Absorption and Distribution 12 Transporter Interactions in the ADME Pathway of Drugs 13 Accumulation of Drugs in Tissues 14 Salt and Cocrystal Form Selection 15 Dissolution 16 Stability: Physical and Chemical 17 Dosage Formulation 18 Cytochrome P450 Enzymes 19 Metabolism Kinetics 20 Drug Clearance 21 In Vitro Metabolism in Preclinical Drug Development 22 Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug–Drug Interactions 23 In Vivo Metabolism in Preclinical Drug Development 24 In Vitro Evaluation of Metabolic Drug–Drug Interactions: Scientific Concepts and Practical Considerations 25 Mechanisms and Consequences of Drug–Drug Interactions 26 Species Comparison of Metabolism in Microsomes and Hepatocytes 27 Metabolite Profiling and Structural Identification 28 Linkage Between Toxicology of Drugs and Metabolism 29 Allometric Scaling 30 Interrelationship between Pharmacokinetics and Metabolism 31 Experimental Design Considerations in Pharmacokinetic Studies 32 Bioavailability and Bioequivalence Studies 33 Mass Balance Studies 34 Pharmacodynamics 35 Physiologically Based Pharmacokinetic Modeling 36 Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profile of Drugs: The Thrombocytopenia Case Study 37 Regulatory Requirements for INDs/FIH (First in Human) Studies 38 Data Analysis Preclinical Development: Toxicology 1 Preclinical Drug Development Planning 2 Use of Project Teams in Preclinical Development 3 Relationship between Animal Models and Clinical Research: Using Mucositis As A Practical Example 4 Bacterial Mutation Assay In Vitro Mammalian Cell Mutation Assays 6 In Vitro Mammalian Cytogenetic Tests 7 In vivo Genotoxicity Assays 8 Repeat Dose Toxicity Studies 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment 10 Safety Assessment Studies: Immunotoxicity 11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects 12 Reproductive and Developmental Toxicology 13 Carcinogenicity Studies 14 Toxicokinetics: An Integral Component of Preclinical Toxicity Studies 15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data 16 Toxicologic Pathology 17 Secondary Pharmacodynamic Studies and In vitro Pharmacological Profiling 18 Current Practices in Safety Pharmacology 19 Safety Assessment of Biotechnology-derived Therapeutics 20 Preclinical Development of Protein Pharmaceuticals: An overview 21 The Pharmacogenomics of Personalized Medicine 22 Genomics 23 Proteomics 24 Toxicogenomics in Preclinical Development 25 Toxicoproteomics: Preclinical Studies 26 Regulatory Considerations 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA) 28 Selection and Utilization of CROs for Safety Assessment 29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) 30 Drug Impurities and Degradants and Their Safety Qualification 31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment Drug Metabolism: Concepts and Applications 1 Historical Perspective 2 Factors Affecting Metabolism 3 Biotransformations in Drug Metabolism 4 In Vivo Metabolite Kinetics 5 Pharmacogenetics and Pharmacogenomics 6 Introduction to Drug Transporters 7 Automated Drug Screening for ADMET Properties 8 Mass Spectrometry 9 Approaches to Performing Metabolite Elucidation: One Key to Success in Drug Discovery and Development 10 Structural Modifications of Drug Candidates: How Useful Are They in Improving Metabolic Stability of New Drugs? Part I: Enhancing Metabolic Stability 11 Structural Modifications of Drug Candidates: How Useful Are They in Improving PK Parameters of New Drugs? Part II: Drug Design Strategies 12 Minimizing the Potential for Drug Bioactivation of Drug Candidates to Success in Clinical Development 13 Screening for Reactive Metabolites Using Genotoxicity Arrays and Enzyme/DNA Biocolloids 14 Enzyme Inhibition 15 Evaluating and Predicting Human Cytochrome P450 Enzyme Induction 16 An Introduction to Metabolic Reaction Phenotyping 17 Nuclear Receptor-Mediated Gene Regulation in Drug Metabolism 18 Characterization of Cytochrome P450 Mechanism-Based Inhibition 19 Clinical Drug–Drug Interactions 20 Pharmaceutical Excipients in Drug–Drug Interaction 21 The Role of Drug Metabolism in Toxicity 22 Allergic Reactions to Drugs 23 Chemical Mechanisms in Toxicology 24 Mechanisms of Reproductive Toxicity 25 An Introduction to Toxicogenomics 26 Role of Bioactivation Reactions in Chemically Induced Nephrotoxicity 27 Drug Metabolism in Regulatory Guidances, Clinical Trials, and Product Labeling Drug Safety Evaluation, 2nd Edition 1 Drug Development Process and Global Pharmaceutical Marketplace 2 Regulation of Human Pharmaceutical Safety 3 Prior Art and Its Use in Safety Assessment Process 4 Screens in Safety and Hazard Assessment 5 Formulations, Routes, and Dosage Design 6 Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation 7 Genotoxicity 8 Repeat-Dose Toxicity Studies 9 Immunotoxicology in Drug Development 10 Nonrodent Animal Studies 11 Developmental and Reproductive Toxicity Testing 12 Carcinogenicity Studies 13 Histopathology in Nonclinical Pharmaceutical Safety Assessment 14 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment 15 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation 16 Safety Pharmacology 17 Special Concerns for Preclinical Evaluation of Biotechnology Products 18 Safety Assessment of Inhalant and Dermal Route Drugs 19 Special-Case Products: Imaging Agents and Oncology Drugs 20 Occupational Toxicology in Pharmaceutical Industry 21 Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals 22 Application of In Vitro Techniques in Drug Safety Assessment 23 Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond 24 Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses 25 Statistics in Pharmaceutical Safety Assessment 26 Combination Products: Drugs and Devices 27 Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals 28 Selected Regulatory and Toxicological Acronyms 29 Definition of Terms and Lexicon of Clinical Observations in Nonclinical? (Animal) Studies 30 Notable Regulatory Internet Addresses 31 Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents 32 Common Vehicles for Nonclinical Evaluation of Therapeutic Agents 33 Global Directory of Contract Toxicology Laboratories Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials 1 Biopharmaceuticals: Definition and Regulation 2 Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact 3 The Principles of ICH S6 and the Case-by-Case Approach 4 Implementation of ICH S6: EU Perspective 5 Implementation of ICH S6: Japanese Perspective 6 Implementation of ICH S6: US Perspective 7 Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and Costs 8 Demonstration of Comparability of a Licensed Product after a Manufacturing Change 9 Selection of Relevant Species 10 Tissue Cross-Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity Testing 11 Physiologic IgG Biodistribution, Transport, and Clearance: Implications for Monoclonal Antibody Products 12 The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species 13 Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals 14 Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals 15 Genetic Toxicology Testing of Biopharmaceuticals 16 General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals 17 Reproductive Toxicity Testing for Biopharmaceuticals 18 Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates 19 Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals 20 Immunogenicity of Therapeutic Proteins and the Assessment of Risk 21 Assessment of Autoimmunity and Hypersensitivity 22 Current Practices in the Preclinical Safety Assessment of Peptides 23 Enzyme Replacement Therapies 24 Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities 25 Preclinical Safety Evaluation of Biological Oncology Drugs 26 Preclinical Safety Evaluation of Monoclonal Antibodies 27 Immunomodulatory Biopharmaceuticals and Risk of Neoplasia 28 Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics 29 Preclinical Safety Evaluation of Immunotoxins 30 Preclinical Safety Evaluation of Blood Products 31 Preclinical Safety Evaluation of Viral Vaccines 32 Preclinical Safety Evaluation of Biopharmaceuticals 33 Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies 34 Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device) 35 Tissue Engineered Products: Preclinical Development of Neo-Organs 36 GLP Requirements and Current Practices 37 Preclinical Safety Study Design Templates and Estimated Costs 38 Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals 39 Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals 40 Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals Clinical Trials 1 Introduction to Clinical Trials 2 Regulatory Requirements for Investigational New Drug 3 Preclinical Assessment of Safety in Human Subjects 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies 5 History of Clinical Trial Development and the Pharmaceutical Industry 6 Adaptive Research 7 Organization and Planning 8 Process of Data Management 9 Clinical Trials Data Management 10 Clinical Trials and the Food and Drug Administration 11 Phase I Clinical Trials 12 Phase II Clinical Trials 13 Designing and Conducting Phase III Studies 14 Phase IV: Postmarketing Trials 15 Phase IV and Postmarketing Clinical Trials 16 Regulatory Approval New Paradigm for Analyzing Adverse Drug Events 18 Clinical Trials in Interventional Cardiology: Focus on XIENCE V Drug-Eluting Stent 19 Clinical Trials Involving Oral Diseases 20 Dermatology Clinical Trials 21 Emergency Clinical Trials 22 Gastroenterology 23 Gynecology Randomized Control Trials 24 Special Population Studies (Healthy Patient Studies) 25 Musculoskeletal Disorders 26 Oncology 27 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration 28 Paediatrics 29 Clinical Trials in Dementia 30 Clinical Trials in Urology 31 Clinical Trials on Cognitive Drugs 32 Bridging Studies in Pharmaceutical Safety Assessment 35 Randomized Controlled Trials 33 Brief History of Clinical Trials on Viral Vaccines 34 Methods of Randomization 36 Cross-Over Designs You have free access to this content 37 Biomarkers 38 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis 39 Review Boards 40 Size of Clinical Trials 41 Blinding and Placebo 42 Pharmacology 43 Modeling and Simulation in Clinical Drug Development 44 Monitoring 45 Inference Following Sequential Clinical Trials 46 Statistical Methods for Analysis of Clinical Trials 47 Explanatory and Pragmatic Clinical Trials 48 Ethics of Clinical Research in Drug Trials 49 Ethical Issues in Clinical Research 50 Regulations 51 Future Challenges in Design and Ethics of Clinical Trials 52 Proof-of-Principle/Proof-of-Concept Trials in Drug Development Biomarkers in Drug Development: Practice, Application, and Strategy 1 Biomarkers Are Not New 2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 3 Enabling Go/No Go Decisions 4 Imaging as a Localized Biomarker: Opportunities and Challenges 5 Protein Biomarker Discovery Using Mass Spectrometry–Based Proteomics 6 Quantitative Multiplexed Patterning of Immune-Related Biomarkers 7 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity 8 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules 9 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective 10 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 11 Molecular Biomarkers from a Diagnostic Perspective 12 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation 13 Importance of Statistics in the Qualification and Application of Biomarkers 14 Qualification of Safety Biomarkers for Application to Early Drug Development 15 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor 16 Biomarkers for the Immunogenicity of Therapeutic Proteins and Its Clinical Consequences 17 New Markers of Kidney Injury 18 Translational Medicine—a Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 19 Clinical Validation and Biomarker Translation 20 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations 22 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints 23 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development 24 Integrating Molecular Testing into Clinical Applications 25 Biomarkers for Lysosomal Storage Disorders 26 Value Chain in the Development of Biomarkers for Disease Targets 27 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 28 Integrating Academic Laboratories Into Pharmaceutical Development 29 Funding Biomarker Research and Development through the Small Business Innovative Research Program 30 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 31 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to be Rare or Hard to Find 32 Biomarker Patent Strategies: Opportunities and Risks 33 IT Supporting Biomarker-Enabled Drug Development 34 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine 35 Ethics of Biomarkers: the Borders of Investigative Research, Informed Consent, and Patient Protection 36 Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time 37 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective 38 Nanotechnology-Based Biomarker Detection Pharmaceutical Biotechnology 1 From Gene to Product: the Advantage of Integrative Biotechnology 2 Sequencing the Human Genome: Was it Worth It? 3 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules 4 Integrated Development of Glycobiologics: from Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems 5 R&D Paradigm Shift and Billion-Dollar Biologics 6 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care 7 Toxicogenomics 8 Preclinical Pharmacokinetics 9 Strategies for the Cytosolic Delivery of Macromolecules: An Overview 10 Basic Issues in the Manufacture of Macromolecules 11 Process Validation for Biopharmaceuticals 12 Stability Assessment and Formulation Characterization 13 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development 14 Pegylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism 15 Unexpected Benefits of a Formulation: Case Study with Erythropoetin 16 Capillary Separation Techniques 17 Pharmaceutical Bioassay 18 Analytical Considerations for Immunoassays for Macromolecules 19 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids 20 Bioanalytical Method Validation for Macromolecules 21 Microarrays in Drug Discovery and Development 22 Genetic Markers and Genotyping Analyses for Genetic Disease Studies 23 Proteins: Hormones, Enzymes, and Monoclonal Antibodies—Background 24 Formulation and Delivery Issues of Therapeutic Proteins 25 Pharmacokinetics 26 Immunogenicity of Therapeutic Proteins 27 Development and Characterization of High-Affinity Anti-Topotecan IgG and Fab Fragments 28 Recombinant Antibodies for Pathogen Detection and Immunotherapy 29 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted In Situ Radiotherapy of Malignancies 30 Gene Therapy—Basic Principles and the Road from Bench to Bedside 31 Plasmid DNA and Messenger RNA for Therapy 32 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies 33 Pharmacokinetics Of Nucleic-Acid-Based Therapeutics 34 Case Studies—Development of Oligonucleotides 35 RNA Interference: The Next Gene-Targeted Medicine 36 Delivery Systems For Peptides/Oligonucleotides And Lipophilic Nucleoside Analogs 37 Growth Factors and Cytokines 38 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics 39 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin 40 Production and Purification of Adenovirus Vectors for Gene Therapy 41 Assessing Gene Therapy By Molecular Imaging 42 Overview of Stem and Artificial Cells 43 Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products 44 Intellectual Property and Biotechnology 45 Comparability Studies for Later-Generation Products—Plant-Made Pharmaceuticals 46 Biosimilars 47 The Promise of Individualized Therapy 48 Enhanced Proteomic Analysis by HPLC Prefractionation 49 An Overview of Metabonomics Techniques and Applications Bioterrorism Pharmaceutical Manufacturing: Production and Processes 1 Manufacturing Specialties 2 Regulatory Considerations in Approval of Follow-On Protein Drug Products 3 Radiopharmaceutical Manufacturing 4 Sterile Product Manufacturing 5 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors 6 Packaging and Labeling 7 Clean-Facility Design, Construction, and Maintenance Issues 8 Solid Dosage Forms 9 Semisolid Dosages: Ointments, Creams, and Gels 10 Liquid Dosage Forms 11 Controlled-Release Dosage Forms 12 Progress in Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein 13 Liposomes and Drug Delivery 14 Biodegradable Nanoparticles 15 Recombinant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation 16 Nasal Delivery of Peptide and Nonpeptide Drugs 17 Nasal Powder Drug Delivery 18 Aerosol Drug Delivery 19 Ocular Drug Delivery 20 Microemulsions as Drug Delivery Systems 21 Transdermal Drug Delivery 22 Vaginal Drug Delivery 23 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powders and Tablet Characterization 24 Role of Preformulation in Development of Solid Dosage Forms 25 Tablet Design 26 Modeling and Informatics in Drug Design 27 Controlled Release of Drugs from Tablet Coatings 28 Tablet Compression 29 Effects of Grinding in Pharmaceutical Tablet Production 30 Oral Extended-Release Formulations 31 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field 32 Nanotechnology in Pharmaceutical Manufacturing 33 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 34 Oil-in-Water Nanosized Emulsions: Medical Applications Pharmaceutical Manufacturing: Regulations and Quality 1 Good Manufacturing Practices (GMP) and Related FDA Guidelines 2 Enforcement of Current Good Manufacturing Practices 3 Scale-Up and Postapproval Changes (SUPAC) Regulations 4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 5 National GMP Regulations and Codes and International GMP Guides and Guidelines: Correspondences and Differences 6 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems 7 Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment 8 Creating and Managing a Quality Management System 9 Quality Process Improvement 10 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 11 Process Analytical Technology 12 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 13 Personnel Training in Pharmaceutical Manufacturing 14 Origin of Contamination 15 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatogaphy–Tandem Mass Spectrometry 16 Microbiology of Nonsterile Pharmaceutical Manufacturing 17 Stability and Shelf Life of Pharmaceutical Products 18 Drug Stability 19 Effect of Packaging on Stability of Drugs and Drug Products 20 Pharmaceutical Product Stability 21 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics 22 Analytical Method Validation: Principles and Practices 23 Analytical Method Validation and Quality Assurance 24 Validation of Laboratory Instruments 25 Pharmaceutical Manufacturing Validation Principles Pharmaceutical Formulation 1 New Approaches to the Characterization of Drug Candidates by Solid-State NMR Development of Therapeutic Agents Handbook 1 Current Needs for New Therapeutic Agents and Discovery Strategies—A Systems Pharmacology Approach 2 Target Selection in Drug Discovery 3 New Drug Applications 4 From Concept to the Clinics: Development of Cancer Therapeutics 5 Development of Countermeasures for Bioterrorism in the United States 6 Development and Application of Conformation-Selective Integrin Antibodies 7 Pain Management Market Overview 8 Antiviral Market Overview 9 High-Throughput Screening for Small-Molecule Drug Discovery 10 Mass Spectrometry 11 Molecular Screening for Therapeutic Agents 12 Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing 13 Development of Antimicrobial Peptides as Therapeutic Agents 14 Antibodies for Human Diseases 15 Combinatorial Compounds and Drug Discovery 16 Locoregional Chemoradiotherapy of Cancer Using Hydrogel 17 RNAi-Mediated Therapeutics 18 Crystallography 19 PEGylation 20 Gold Standard Animal Models 21 Discovery of Vaccine Adjuvants 22 Oral Delivery of Macromolecules for the Development of Therapeutic Agents 23 Aerosol Drug Delivery to the Lungs 24 Resistance to Antiplatelet Therapy 25 Antibiotic Development 26 Antimicrobial Resistance in Biofilms: A Sticky Situation 27 Drotrecogin Alfa Activated (Recombinant Human Activated Protein C, Xigris) 28 Anti-Inflammatory Therapeutics 29 Anti-Inflammatory/Analgesics: An In-Depth Look at p38 MAP Kinases 30 Cardiovascular Disease: In-Depth Look 31 Ezetimibe and Cholesterol Absorption 32 Cardiology—In-Depth Look: Kinases as Therapeutic Targets in the Heart 33 Statins in the Reduction of Cardiovascular Events 34 Cardiology—In-Depth Look: Advances in Antiplatelet Therapy 35 Gastrointestinal Disorders: A Focus on Acid-Suppressive Agents 36 Pharmacology of Vasopressin and the Renin–Angiotensin–Aldosterone System 37 New Drugs and Nutraceuticals in the Treatment of Osteoarthritis 38 Development of Anticytokine Agents for Rheumatoid Arthritis 39 Overview of CNS Neuropharmaceuticals 40 Thinking Outside the Box in Alzheimer Disease Treatment 41 Neurotrophic Factors as Novel Therapeutic Targets 42 Oncology 43 Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia 44 Aromatase Inhibitors for Breast Cancer 45 Evolution of Selective Estrogen and Androgen Receptor Modulators: Status of Current Therapy and New Drug Development 46 In-Depth Look: Anti-TNF-α Therapies 47 Development of Therapeutic Agents: The Maternal–Fetal Perspective 48 History of Antipsychotic Drug Development 49 Radiopharmaceuticals and Medical Imaging: Development of Radioimmumoconjugates for Radioimmunoimaging and Radioimmunotherapy of Malignant Diseases 50 Therapeutic Drug Development for Kidney Diseases Targeting Chemokines and Angiogenesis in Rheumatoid Arthritis 52 Development of Therapeutic Agents: Methods and Approaches in the Development of Vaccines Against Protozoan Parasites 53 Toxicology 54 Development of Phosphodiesterase 4 Inhibitors for Allergic and Nonallergic Inflammatory Diseases of the Airways Analysis and Pharmaceutical Quality 1 Applications of High Performance Ion-Exchange Chromatography in the Pharmaceutical Industry 2 Automation in Quality 3 Capillary Electrophoresis of Dendrimer-Related Medical Nanodevices 4 From Concept to the Clinics: Development of Novel Large Molecule Cancer Therapeutics 5 Karl Fischer Titration: Determination of Water Content in Pharmaceuticals 6 EDTA Titrations 7 Electronic Circular Dichroism Spectroscopy 8 Good Manufacturing Practices—Steps to Improve Quality 9 High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis 10 Microdialysis 11 Handbook of Analysis and Pharmaceutical Quality: Nano-Methods 12 Quality by Design for the Pharmaceutical Industry 13 X-Ray Fluorescence Spectrometry in Medicine 14 Statistical Tools 15 Systems-Based Approach to Laboratory Compliance with the Current Good Manufacturing Practice (CGMP) Regulations 16 Uses of X-Ray Powder Diffraction In the Pharmaceutical Industry 17 Water Determination By Karl Fischer Titration 18 Vibrational Circular Dichroism: Ensuring Quality of Pharmaceutical Products Drug-Drug Interactions for Therapeutic Biologics 1 Drug Interactions for Therapeutic Proteins: A Journey Just Beginning 2 Pharmacokinetic and Pharmacodynamic-Based Drug Interactions for Therapeutic Proteins 3 Drug Interaction Assessment Strategies: Small Molecules versus Therapeutic Proteins 4 Model-Independent and Model-Based Methods to Assess Drug–Drug Interactions for Therapeutic Proteins 5 Utility of In Vitro Methods in Drug–Drug Interaction Assessment and Prediction for Therapeutic Biologics 6 Use of Animal Models for Projection of Clinical Drug–Drug Interactions for Therapeutic Proteins 7 The Cocktail Approach and Its Utility in Drug–Drug Interaction Assessments for Therapeutic Proteins 8 Logistic Considerations in Study Design for Biologic Drug–Drug Interaction Assessments 9 Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics Scientific Perspectives on Therapeutic Protein Drug–Drug Interaction Assessments 11 Disease–Drug–Drug Interaction Assessments for Tocilizumab—A Monoclonal Antibody against Interleukin-6 Receptor to Treat Patients with Rheumatoid Arthritis 12 Drug–Drug Interactions for Etanercept—A Fusion Protein 13 Drug Interactions of Cytokines and Anticytokine Therapeutic Proteins 14 Drug Interactions for Growth Factors and Hormones 15 Drug–Drug Interactions for Nucleic Acid-Based Derivatives 16 Monographs for Drug-Drug Interactions of Therapeutics Biologics Nanoparticulate Drug Delivery Systems: Strategies, Technologies, and Applications 1 Tumor-Targeted Nanoparticles: State-of-the-Art and Remaining Challenges 2 Applications of Ligand-Engineered Nanomedicines 3 Lipid Nanoparticles for the Delivery of Nucleic Acids 4 Photosensitive Liposomes as Potential Targeted Therapeutic Agents 5 Multifunctional Dendritic Nanocarriers: The Architecture and Applications in Targeted Drug Delivery 6 Chitosan-Based Nanoparticles for Biomedical Applications 7 Polymer–Drug Nanoconjugates 8 Nanocrystals Production, Characterization, and Application for Cancer Therapy 9 Clearance of Nanoparticles During Circulation 10 Drug Delivery Strategies for Combating Multiple Drug Resistance 11 Intracellular Trafficking of Nanoparticles: Implications for Therapeutic Efficacy of the Encapsulated Drug 12 Toxicological Assessment of Nanomedicine Biological Drug Products: Development and Strategies 1 An Overview of the Discovery and Development Process for Biologics 2 Nonclinical Safety Assessment of Biologics, Including Vaccines 3 Clinical Assessment of Biologic Agents 4 Key Regulatory Guidelines for the Development of Biologics in the United States and Europe 5 Landscape and Consideration of Intellectual Property for Development of Biosimilars 6 Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization 7 Cell Culture Processes in Monoclonal Antibody Production 8 Protein and Peptide Purification 9 Chemical and Genetic Modification 10 Analytical Characterization of Proteins and Peptides 11 Protein and Peptide Formulation Development 12 Regulatory Strategies and Lessons in the Development of Biosimilars 13 Vaccine Development: History, Current Status, and Future Trends 14 Role and Application of Adjuvants and Delivery Systems in Vaccines 15 Methods for Characterizing Proteins in Aluminum Adjuvant Formulations 16 The State of the Art and Future of Gene Medicines 17 Nucleic Acid Vaccines 18 Multifunctional Polymeric Nanosystems for RNA Interference Therapy 19 Advent and Maturation of Regenerative Medicine 20 Conventional and Novel Container Closure and Delivery Systems 21 Controlled-Release Systems for Biologics 22 Routes of Delivery for Biological Drug Products Pharmaceutical Amorphous Solid Dispersions 1 Introduction to Amorphous Solid Dispersions 2 Polymers and Surfactants 3 Amorphous Solid Dispersion Screening 4 Solid-State Characterization of Amorphous Dispersions 5 Physical Stability and Crystallization Inhibition 6 Solubility and Dissolution Considerations for Amorphous Solid Dispersions 7 Translational Development of Amorphous Dispersions 8 Preclinical and Clinical Studies 9 Spray Drying and Scale-Up 10 Hot Melt Extrusion of Amorphous Solid Dispersions 11 Formulation Development of Amorphous Dispersions Scientific and Regulatory Considerations in Product Development1 Patenting Amorphous Solid Dispersions of Pharmaceuticals1 14 Monographs on Polymers and Surfactants |
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