Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Three, Liquid Products
Niazi, Sarfaraz K.
Taylor & Francis Ltd
11/2019
420
Dura
Inglês
9781138103221
15 a 20 dias
1302
Descrição não disponível.
Part I: Regulatory and Manufacturing Guidance
Manufacturing Considerations in Liquid Formulations
Oral Solutions and Suspensions
The FDA Drug Product Surveillance Program
Changes to Approved NDAs and aNDAs
Formulation Considerations of Liquid Products
Container Closure Systems
Material for Containers
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
Product-Specific Bioequivalence Testing Protocols
Formulation Considerations
Pediatric Pharmaceutical EU Legislation
Pediatric Formulations
SOP and Specification to Establish Electronic Submission to Regulatory Agencies
Part II: Manufacturing Formulations
Part III: Commercial Pharmaceutical Products
Manufacturing Considerations in Liquid Formulations
Oral Solutions and Suspensions
The FDA Drug Product Surveillance Program
Changes to Approved NDAs and aNDAs
Formulation Considerations of Liquid Products
Container Closure Systems
Material for Containers
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
Product-Specific Bioequivalence Testing Protocols
Formulation Considerations
Pediatric Pharmaceutical EU Legislation
Pediatric Formulations
SOP and Specification to Establish Electronic Submission to Regulatory Agencies
Part II: Manufacturing Formulations
Part III: Commercial Pharmaceutical Products
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
bioequivalence regulatory;bioequivalence testing protocols;cGMP compliance;dissolution testing;Pre-approval inspections;good manufacturing practices;Stability and bioequivalence testing;manufacturing guidelines;Packaging commodity development;pharmaceutical manufacturing formulations;Formulating drugs;preapproval inspections;Changes to aNDAs, and aBLAs;U.S. food and drug administration;bioequivalence testing;uncompressed solid dosage forms;uncompressed solid products;liquid products;Amberlite IRP69;cGMP formulations;Dry Powder Inhalers;drug product safety;Solid Oral Dosage Form Products;Full Study Design;Proposed Retest Period;Primary Degradant;Intermediate Storage Condition;Container Closure System;Secondary Packaging Component;Drug Substance;Drug Product;Retest Period;Dosage Form;Formal Stability Study;Accelerated Storage Condition;Ich Q1A;Parent Guideline;Oral Solid Dosage Forms;Shelf Life Estimation;Proposed Shelf Life;Long Term Storage Condition;Normal Healthy Males;Packaging Component;Photostability Testing;Primary Packaging Components
Part I: Regulatory and Manufacturing Guidance
Manufacturing Considerations in Liquid Formulations
Oral Solutions and Suspensions
The FDA Drug Product Surveillance Program
Changes to Approved NDAs and aNDAs
Formulation Considerations of Liquid Products
Container Closure Systems
Material for Containers
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
Product-Specific Bioequivalence Testing Protocols
Formulation Considerations
Pediatric Pharmaceutical EU Legislation
Pediatric Formulations
SOP and Specification to Establish Electronic Submission to Regulatory Agencies
Part II: Manufacturing Formulations
Part III: Commercial Pharmaceutical Products
Manufacturing Considerations in Liquid Formulations
Oral Solutions and Suspensions
The FDA Drug Product Surveillance Program
Changes to Approved NDAs and aNDAs
Formulation Considerations of Liquid Products
Container Closure Systems
Material for Containers
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
Product-Specific Bioequivalence Testing Protocols
Formulation Considerations
Pediatric Pharmaceutical EU Legislation
Pediatric Formulations
SOP and Specification to Establish Electronic Submission to Regulatory Agencies
Part II: Manufacturing Formulations
Part III: Commercial Pharmaceutical Products
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
bioequivalence regulatory;bioequivalence testing protocols;cGMP compliance;dissolution testing;Pre-approval inspections;good manufacturing practices;Stability and bioequivalence testing;manufacturing guidelines;Packaging commodity development;pharmaceutical manufacturing formulations;Formulating drugs;preapproval inspections;Changes to aNDAs, and aBLAs;U.S. food and drug administration;bioequivalence testing;uncompressed solid dosage forms;uncompressed solid products;liquid products;Amberlite IRP69;cGMP formulations;Dry Powder Inhalers;drug product safety;Solid Oral Dosage Form Products;Full Study Design;Proposed Retest Period;Primary Degradant;Intermediate Storage Condition;Container Closure System;Secondary Packaging Component;Drug Substance;Drug Product;Retest Period;Dosage Form;Formal Stability Study;Accelerated Storage Condition;Ich Q1A;Parent Guideline;Oral Solid Dosage Forms;Shelf Life Estimation;Proposed Shelf Life;Long Term Storage Condition;Normal Healthy Males;Packaging Component;Photostability Testing;Primary Packaging Components
