Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)

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.\nThe 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.\nThe book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences, 204)

Science & Math

Shargel, Leon

Kanfer, Isadore

Chemistry

CRC-Press

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.

Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences, 180)

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.

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.A This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Generic Drug Product Development: Bioequivalence, International Regulatory Requirements, and Specialty Drug Products (Three-Volume Set)

Reference

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Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences, 204)

Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences, 180)

Generic Drug Product Development: Specialty Dosage Forms (Drugs and the Pharmaceutical Sciences)

Generic Drug Product Development: Bioequivalence, International Regulatory Requirements, and Specialty Drug Products (Three-Volume Set)