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Published in 1994: This text focuses on the determination of bioequivalence between formulations that are pharmaceutically equivalent and manufactured using acceptable chemistry, manufacturing and controls and in accordance with Good Manufacturing Practices.

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

Rising health care costs have for many years focused congressional attention upon the development and availability of prescription drugs. Recently, the presence of'authorized generic'pharmaceuticals in the drug marketplace has been the subject of congressional concern. An'authorized generic'is a pharmaceutical that is marketed by or on behalf of a brand-named drug company, but is sold under a generic name. The brand-name firm may distribute the drug under its own auspices or via a license to a generic drug company. The price of this'authorized copy'is ordinarily lower than that of the brand-name drug. Some sources refer to authorized generics as'branded,''flanking,'or'pseudo'generics.'This book presents an analysis of the innovation and public health issues relating to authorized generic drugs beginning with a review of the procedures through which independent generic drug companies receive government permission to market their products and resolve patent disputes with brand-name firms and consumer welfare.

Le domande che il medico si pone in relazione alla prescrizione dei farmaci in modalità off-label, ossia al di fuori di quanto previsto dal Riassunto delle Caratteristiche del Prodotto autorizzato, sono numerose e spesso non è semplice trovare le risposte. A partire dalle normative che regolano la prescrizione off-label, il testo fornisce indicazioni per usare i farmaci in modo consapevole, sulla base delle evidenze scientifiche e in modo conforme a quanto stabilito dalle Leggi italiane. Alcuni esempi, nell'ambito della pediatria, dell'oncologia e della psichiatria, ne chiariscono l'uso corretto nella pratica clinica.

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 dru

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 therapeutica

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 comp

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

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, ex