Pharmaceutical Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications

Volume 3: Regulations, Validation and the Future

Nema, Sandeep; Ludwig, John D.

Taylor & Francis Ltd

10/2024

326

Mole

9781032922010

Pré-lançamento - envio 15 a 20 dias após a sua edição

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Volume 3: CGMP Regulations of Parenteral Drugs L Terry E. Munson Risk Assessment and Mitigation in Aseptic Processing L James Agalloco and James Akers Validation of Drug Product Manufacturing Processes: NCEs and NBEs L Karoline Bechtold-Peters Visual Inspection L Maria Toler and Sandeep Nema Advances in Parenteral Injection Devices and Aids L Donna L. French and James J. Collins, Jr. SiRNA Targeting Using Injectable Nano-based Delivery Systems L Lan Feng and Russell J. Mumper Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls L Sandeep Nema Techniques to Evaluate Damage and Pain on Injection L Gayle A. Brazeau, Jessica Klapa and Pramod Gupta Parenteral Product Specifications and Stability L Michael Bergren Extractables and Leachables L Edward Smith and Dianne M. Paskiet Process Analytical Technology and Rapid Microbial Methods L Geert Verdonk and Tony Cundell Quality Assurance Michael Gorman L Application of Quality by Design in CMC Development L Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh Future of Parenteral Manufacturing L James Agalloco, James Akers, and Russell Madsen
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Drug Products;Aseptic Processing;drug;RABS;product;Sterility Testing;aseptic;Prefilled Syringe;processes;Ich Q8;sterility;Drug Substance;test;Parametric Release;substances;Delivery System;restricted;Drug Product Containers;access;Ich Q1E;barrier;Medicinal Product;Ich Q6A;GMP Regulation;Container Closure System;ATP Bioluminescence;Ich Q8R;Ich Q6B;Rt Ic Le;Tissue Damage;G3 PAMAM Dendrimer;PAT Application;Design History File;Genotoxic Impurities;siRNA Delivery