Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products
Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products
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Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products

Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products

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Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products – Mani

Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products – Mani

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Synthetic Therapeutic Peptide APIs: Documentation for API Sameness & Related Impurities

Synthetic Therapeutic Peptide APIs: Documentation for API Sameness & Related Impurities

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Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products

Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products

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Evaluating immunogenicity risk of complex peptide products

Evaluating immunogenicity risk of complex peptide products

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Considerations in Demonstrating Complex API Sameness (7of39) Complex Generics 2018

Considerations in Demonstrating Complex API Sameness (7of39) Complex Generics 2018

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Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics – Sep. 25-26, 2019

Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics – Sep. 25-26, 2019

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BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

BE Approaches for Long Acting Drug Products (14of35) Complex Generics – Sep. 25-26, 2019

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Strategies to Demonstrate Complex API Sameness (10of35) Complex Generics – Sep. 25-26, 2019

Strategies to Demonstrate Complex API Sameness (10of35) Complex Generics – Sep. 25-26, 2019

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Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generics

Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generics

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Bachem capabilities to address the new FDA guideline for synthetic peptides

Bachem capabilities to address the new FDA guideline for synthetic peptides

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Aimee Mattei: Forecasting the immunogenicity of peptide impurities for FDA ANDAs

Aimee Mattei: Forecasting the immunogenicity of peptide impurities for FDA ANDAs

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Narasimha Rao: FDA recommendations on immunogenicity risk assessment for synthetic peptide drugs

Narasimha Rao: FDA recommendations on immunogenicity risk assessment for synthetic peptide drugs

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Regulatory Considerations in Demonstrating Complex API Sameness

Regulatory Considerations in Demonstrating Complex API Sameness

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Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies

Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies

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Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6of39) Complex Generics 2018

Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6of39) Complex Generics 2018

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Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018

Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018

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Modeling Immunogenicity of Peptide Impurities with WHIM (the What if Machine) Algorithm

Modeling Immunogenicity of Peptide Impurities with WHIM (the What if Machine) Algorithm

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Product-Specific Guidances for Complex Generic Drugs

Product-Specific Guidances for Complex Generic Drugs

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Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018

Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018

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