Pharmaceutical Product Development

In Vitro-In Vivo Correlation

Chilukuri Dakshina Murthy, Gangadhar Sunkara, David Young

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English

CRC Press
02 December 2019

Medicine: general issues; Biology, life sciences; Pharmaceutical technology

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.

Edited by: Chilukuri Dakshina Murthy, Gangadhar Sunkara, David Young
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 229mm, Width: 152mm,
Weight: 453g
ISBN: 9780367453176
ISBN 10: 0367453177
Pages: 224
Publication Date: 02 December 2019
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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

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