Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
portes grátis
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Four, Semisolid Products
Niazi, Sarfaraz K.
Taylor & Francis Ltd
10/2024
502
Mole
9781032919232
Pré-lançamento - envio 15 a 20 dias após a sua edição
Descrição não disponível.
Part I Regulatory and Manufacturing Guidance
Chapter 1. Waiver of In Vivo Bioequivalence Study
Chapter 2. Quality Risk Management
Chapter 3. Pharmaceutical Quality System
Chapter 4. Pharmaceutical Development
Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Chapter 7. Validation of Analytical Procedures
Chapter 8. Bioequivalence Testing of Topical Drugs
Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection
Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products
Chapter 11. Topical Testing of Transdermal Drug Products
Chapter 12. Impurities Profiling: Drug Substance
Chapter 13. Impurities in New Drug Products
Chapter 14. Formulation Factors in Semisolid Dosage Forms
Chapter 15. Pediatric Research Equity Act (PREA) Compliance
Chapter 16. Global Regulatory Guidance on Bioequivalence Testing
Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations
Chapter 18. FDA 483 Observations
Chapter 19. WHO Good Manufacturing Guidelines
Appendices
Part II Manufacturing Formulations
Semisolid Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Chapter 1. Waiver of In Vivo Bioequivalence Study
Chapter 2. Quality Risk Management
Chapter 3. Pharmaceutical Quality System
Chapter 4. Pharmaceutical Development
Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Chapter 7. Validation of Analytical Procedures
Chapter 8. Bioequivalence Testing of Topical Drugs
Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection
Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products
Chapter 11. Topical Testing of Transdermal Drug Products
Chapter 12. Impurities Profiling: Drug Substance
Chapter 13. Impurities in New Drug Products
Chapter 14. Formulation Factors in Semisolid Dosage Forms
Chapter 15. Pediatric Research Equity Act (PREA) Compliance
Chapter 16. Global Regulatory Guidance on Bioequivalence Testing
Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations
Chapter 18. FDA 483 Observations
Chapter 19. WHO Good Manufacturing Guidelines
Appendices
Part II Manufacturing Formulations
Semisolid Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
active pharmaceutical ingredients;bioequivalence testing;cGMP compliance;good manufacturing practice;Pre-approval inspections;in vivo bioequivalence study;Stability and bioequivalence testing;manufacturing guidance;Packaging commodity development;nonsterile semisolid dosage forms;Formulating drugs;pharmaceutical development;Changes to aNDAs, and aBLAs;pharmaceutical manufacturing formulations;bioequivalence;pharmaceutical quality system;c-goods manufacturing practice compliance;quality risk management;pharmaceutics;regulatory agencies;scalable commercial formulations;semisolid products;topical drugs;U.S. FDA;Edetate Disodium;Carbomer 934P;Dry Powder Inhalers;Topical Dermatological Drug Product;API Manufacturer;Drug Substance;Ich Q6A;Ich Q9;Ich Guideline;Drug Products;Dosage Forms;Vitro Release;Ich Guideline Q1A;API Process;Inactive Ingredients;Container Closure System;API;Quality Risk Management Process;Vitro Release Testing;Regional GMP Requirement;Stratum Corneum;Methyl Paraben
Part I Regulatory and Manufacturing Guidance
Chapter 1. Waiver of In Vivo Bioequivalence Study
Chapter 2. Quality Risk Management
Chapter 3. Pharmaceutical Quality System
Chapter 4. Pharmaceutical Development
Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Chapter 7. Validation of Analytical Procedures
Chapter 8. Bioequivalence Testing of Topical Drugs
Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection
Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products
Chapter 11. Topical Testing of Transdermal Drug Products
Chapter 12. Impurities Profiling: Drug Substance
Chapter 13. Impurities in New Drug Products
Chapter 14. Formulation Factors in Semisolid Dosage Forms
Chapter 15. Pediatric Research Equity Act (PREA) Compliance
Chapter 16. Global Regulatory Guidance on Bioequivalence Testing
Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations
Chapter 18. FDA 483 Observations
Chapter 19. WHO Good Manufacturing Guidelines
Appendices
Part II Manufacturing Formulations
Semisolid Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Chapter 1. Waiver of In Vivo Bioequivalence Study
Chapter 2. Quality Risk Management
Chapter 3. Pharmaceutical Quality System
Chapter 4. Pharmaceutical Development
Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Chapter 7. Validation of Analytical Procedures
Chapter 8. Bioequivalence Testing of Topical Drugs
Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection
Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products
Chapter 11. Topical Testing of Transdermal Drug Products
Chapter 12. Impurities Profiling: Drug Substance
Chapter 13. Impurities in New Drug Products
Chapter 14. Formulation Factors in Semisolid Dosage Forms
Chapter 15. Pediatric Research Equity Act (PREA) Compliance
Chapter 16. Global Regulatory Guidance on Bioequivalence Testing
Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations
Chapter 18. FDA 483 Observations
Chapter 19. WHO Good Manufacturing Guidelines
Appendices
Part II Manufacturing Formulations
Semisolid Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
active pharmaceutical ingredients;bioequivalence testing;cGMP compliance;good manufacturing practice;Pre-approval inspections;in vivo bioequivalence study;Stability and bioequivalence testing;manufacturing guidance;Packaging commodity development;nonsterile semisolid dosage forms;Formulating drugs;pharmaceutical development;Changes to aNDAs, and aBLAs;pharmaceutical manufacturing formulations;bioequivalence;pharmaceutical quality system;c-goods manufacturing practice compliance;quality risk management;pharmaceutics;regulatory agencies;scalable commercial formulations;semisolid products;topical drugs;U.S. FDA;Edetate Disodium;Carbomer 934P;Dry Powder Inhalers;Topical Dermatological Drug Product;API Manufacturer;Drug Substance;Ich Q6A;Ich Q9;Ich Guideline;Drug Products;Dosage Forms;Vitro Release;Ich Guideline Q1A;API Process;Inactive Ingredients;Container Closure System;API;Quality Risk Management Process;Vitro Release Testing;Regional GMP Requirement;Stratum Corneum;Methyl Paraben
