Translational Medicine
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Translational Medicine
Optimizing Preclinical Safety Evaluation of Biopharmaceuticals
Cavagnaro, Joy A.; Cosenza, Mary Ellen
Taylor & Francis Ltd
05/2024
542
Mole
9780367644451
Pré-lançamento - envio 15 a 20 dias após a sua edição
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1.1 Case-By-Case Approach: Historical Perspective
1.2 Selection of Relevant Animal Models/Species
1.3 Dose Extrapolation to Humans for Novel Biologics
1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans
1.5 Global Regulatory Expectations and Interactions
2.1 "Key Considerations in the Chemistry, Manufacturing and
Controls (CMC) of BioPharmaceuticals"
2.2 Preclinical Toxicology Testing Paradigms
2.3 Inhalation Delivery of Biologics
2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment
2.4.2 Immunogenicity of Therapeutic Proteins
2.4.3 Testing for Off-Target Binding
2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications
2.4.5 Biosimilar Products - A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies
2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound
2.4.7 Due Diligence Regulatory and Preclinical focus
2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products
2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations
3.1 Nonclinical Development of Peptides and Therapeutic Proteins
3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs)
3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases
3.4 Development of Antibody Drug Conjugates
3.5 Preventive and Therapeutic Vaccines
3.6 Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides
3.7 Cellular-based Therapies
3.8 Considerations in the Preclinical Development of Gene Therapy Products
3.9 Genome-Editing Technologies
4.1 Nonclinical Development of Anti-Cancer Biotherapeutics
4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases
4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions
4.4 Nonclinical Development of Biologics for Infectious Diseases
1.2 Selection of Relevant Animal Models/Species
1.3 Dose Extrapolation to Humans for Novel Biologics
1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans
1.5 Global Regulatory Expectations and Interactions
2.1 "Key Considerations in the Chemistry, Manufacturing and
Controls (CMC) of BioPharmaceuticals"
2.2 Preclinical Toxicology Testing Paradigms
2.3 Inhalation Delivery of Biologics
2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment
2.4.2 Immunogenicity of Therapeutic Proteins
2.4.3 Testing for Off-Target Binding
2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications
2.4.5 Biosimilar Products - A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies
2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound
2.4.7 Due Diligence Regulatory and Preclinical focus
2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products
2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations
3.1 Nonclinical Development of Peptides and Therapeutic Proteins
3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs)
3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases
3.4 Development of Antibody Drug Conjugates
3.5 Preventive and Therapeutic Vaccines
3.6 Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides
3.7 Cellular-based Therapies
3.8 Considerations in the Preclinical Development of Gene Therapy Products
3.9 Genome-Editing Technologies
4.1 Nonclinical Development of Anti-Cancer Biotherapeutics
4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases
4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions
4.4 Nonclinical Development of Biologics for Infectious Diseases
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Ich S6;Ich S5;Cynomolgus Monkeys;Tissue Cross-reactivity Study;Ich M3;Toxicity Studies;Repeat Dose Toxicity Studies;Nonclinical Studies;Non-oncology Indications;FIH Study;GLP Toxicology Study;General Toxicity Studies;Animal Studies;Safety Pharmacology;ADAs;Antidrug Antibody Response;Nonclinical Development;Nonclinical Safety;Toxicology Studies;Gene Therapy Products;Starting Dose;Toxicity Assessment;Pharmacologically Relevant;ADCs;FDA Guidance
1.1 Case-By-Case Approach: Historical Perspective
1.2 Selection of Relevant Animal Models/Species
1.3 Dose Extrapolation to Humans for Novel Biologics
1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans
1.5 Global Regulatory Expectations and Interactions
2.1 "Key Considerations in the Chemistry, Manufacturing and
Controls (CMC) of BioPharmaceuticals"
2.2 Preclinical Toxicology Testing Paradigms
2.3 Inhalation Delivery of Biologics
2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment
2.4.2 Immunogenicity of Therapeutic Proteins
2.4.3 Testing for Off-Target Binding
2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications
2.4.5 Biosimilar Products - A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies
2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound
2.4.7 Due Diligence Regulatory and Preclinical focus
2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products
2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations
3.1 Nonclinical Development of Peptides and Therapeutic Proteins
3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs)
3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases
3.4 Development of Antibody Drug Conjugates
3.5 Preventive and Therapeutic Vaccines
3.6 Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides
3.7 Cellular-based Therapies
3.8 Considerations in the Preclinical Development of Gene Therapy Products
3.9 Genome-Editing Technologies
4.1 Nonclinical Development of Anti-Cancer Biotherapeutics
4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases
4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions
4.4 Nonclinical Development of Biologics for Infectious Diseases
1.2 Selection of Relevant Animal Models/Species
1.3 Dose Extrapolation to Humans for Novel Biologics
1.4 READY, AIM, FIRE! The Importance of Strategic Drug Development Plans
1.5 Global Regulatory Expectations and Interactions
2.1 "Key Considerations in the Chemistry, Manufacturing and
Controls (CMC) of BioPharmaceuticals"
2.2 Preclinical Toxicology Testing Paradigms
2.3 Inhalation Delivery of Biologics
2.4.1 Nonclinical Considerations for Biopharmaceutical Comparability Assessment
2.4.2 Immunogenicity of Therapeutic Proteins
2.4.3 Testing for Off-Target Binding
2.4.4 Reproductive, Developmental, & Juvenile Toxicity Assessments and Practical Applications
2.4.5 Biosimilar Products - A Review of Past and Current Regulatory Approval Standards for Preclinical Safety Studies
2.4.6 Nonclinical Safety Strategy for Combinations of Biopharmaceuticals or Biopharmaceutical with Small Molecular Weight Compound
2.4.7 Due Diligence Regulatory and Preclinical focus
2.5 Regulatory Toxicology for Biopharmaceuticals: Preparing for Pre-IND Interactions and Avoiding IND Pitfalls for Oncology and Non-Oncology Products
2.6 Outsourcing and Monitoring Preclinical Studies Including GLP Considerations
3.1 Nonclinical Development of Peptides and Therapeutic Proteins
3.2 Antibodies (Abs) and Related Products Containing Complementarity Determining Regions (CDRs)
3.3 Nonclinical Safety Evaluation of Therapies for Rare Diseases
3.4 Development of Antibody Drug Conjugates
3.5 Preventive and Therapeutic Vaccines
3.6 Understanding the Nonclinical Safety Considerations for Therapeutic Oligonucleotides
3.7 Cellular-based Therapies
3.8 Considerations in the Preclinical Development of Gene Therapy Products
3.9 Genome-Editing Technologies
4.1 Nonclinical Development of Anti-Cancer Biotherapeutics
4.2 Non-Clinical Safety Evaluation of Immunomodulatory Biological Therapeutics for the Treatment of Immune-Mediated Diseases
4.3 Nonclinical Safety Program Considerations for Biologic Therapeutics for Neurodegenerative Conditions
4.4 Nonclinical Development of Biologics for Infectious Diseases
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Ich S6;Ich S5;Cynomolgus Monkeys;Tissue Cross-reactivity Study;Ich M3;Toxicity Studies;Repeat Dose Toxicity Studies;Nonclinical Studies;Non-oncology Indications;FIH Study;GLP Toxicology Study;General Toxicity Studies;Animal Studies;Safety Pharmacology;ADAs;Antidrug Antibody Response;Nonclinical Development;Nonclinical Safety;Toxicology Studies;Gene Therapy Products;Starting Dose;Toxicity Assessment;Pharmacologically Relevant;ADCs;FDA Guidance
