Pharmaceutical Product Development

In Vitro-In Vivo Correlation
Herausgeber: Dakshina Murthy, Chilukuri; Young, David; Sunkara, Gangadhar

• Broschiertes Buch

Produktbeschreibung

During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and pharmacokinetics are collaborating to address physicochemical and biological issues in the early stages of development to avoid problems in later stages. In Vitro-In Vivo Correlation (IVIVC) is a multidisciplinary tool that has been successfully applied in testing the effectiveness of a drug substance. The only comprehensive guide available on IVIVC, this source illustrates the emerging importance of IVIVC in the drug development process, and covers the most recent advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 224
• Erscheinungstermin: 2. Dezember 2019
• Englisch
• Abmessung: 229mm x 152mm x 12mm
• Gewicht: 308g
• ISBN-13: 9780367453176
• ISBN-10: 0367453177
• Artikelnr.: 58438086

Autorenporträt

Dakshina Murthy\, Chilukuri; Sunkara\, Gangadhar; Young\, David

Inhaltsangabe

Introduction. Dissolution: Fundamentals of In Vitro Drug Release and
Biopharmaceutics Classification System (BCS). Pharmacokinetics: Basics of
Drug Absorption from a Biopharmaceutical Perspective. IVIVC Models:
Development and Validation. Computational Approaches to Develop IVIVC
Models. IVIVC - Pharmaceutical Drug/Product Development. Role of IVIVC in
the Early Phases of Drug Discovery and Drug Delivery Technology
Development. IVIVC - Setting Dissolution Specifications. IVIVC - Oral Drug
Delivery: Immediate Release and Extended Release Dosage Forms. In Vitro-In
Vivo Correlation for Modified Release Parenteral Drug Delivery Systems.
IVIVC - Transdermal and Other Novel/Special Drug Delivery Systems.
Regulatory Perspective. Regulatory Guidance on IVIVC: Across the World