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Generic Drug Product Development PDF
Author: Leon Shargel
Publisher: CRC Press
Release Date: 2013-10-24
Size: 19.43 MB
Format: PDF, ePub, Mobi
Category : Medical
Languages : en
Pages : 397
View: 226

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Generic Drug Product Development

Book by Leon Shargel, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Leon Shargel
Publisher: CRC Press
Release Date: 2016-04-19
Size: 24.75 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 288
View: 6870

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Generic Drug Product Development

Book by Leon Shargel, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Isadore Kanfer
Publisher: CRC Press
Release Date: 2007-11-15
Size: 57.57 MB
Format: PDF, Kindle
Category : Medical
Languages : en
Pages : 288
View: 1808

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Generic Drug Product Development

Book by Isadore Kanfer, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Isadore Kanfer
Publisher: CRC Press
Release Date: 2016-04-19
Size: 65.53 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 332
View: 286

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Generic Drug Product Development

Book by Isadore Kanfer, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Leon Shargel
Publisher: CRC Press
Release Date: 2004-12-28
Size: 72.11 MB
Format: PDF, ePub
Category : Medical
Languages : en
Pages : 408
View: 2304

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Generic Drug Product Development

Book by Leon Shargel, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Isadore Kanfer
Publisher: Taylor & Francis US
Release Date: 2010
Size: 63.43 MB
Format: PDF, ePub, Mobi
Category : Generic drugs
Languages : en
Pages : 309
View: 3677

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Generic Drug Product Development

Book by Isadore Kanfer, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.




[PDF] Generic Drug Product Development Download

Generic Drug Product Development PDF
Author: Leon Shargel
Publisher: CRC Press
Release Date: 2010-03-25
Size: 13.78 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 288
View: 4660

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Generic Drug Product Development

Book by Leon Shargel, Generic Drug Product Development Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development books, Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.




[PDF] Generic Drug Product Development International Regulatory Requirements For Bioequivalence Second Edition Download

Generic Drug Product Development  International Regulatory Requirements for Bioequivalence  Second Edition PDF
Author: Isadore Kanfer
Publisher: CRC Press
Release Date: 2016-03-07
Size: 28.45 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 350
View: 705

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Generic Drug Product Development International Regulatory Requirements For Bioequivalence Second Edition

Book by Isadore Kanfer, Generic Drug Product Development International Regulatory Requirements For Bioequivalence Second Edition Books available in PDF, EPUB, Mobi Format. Download Generic Drug Product Development International Regulatory Requirements For Bioequivalence Second Edition books,




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