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GENERIC DRUG PRODUCT DEVELOPMENT

INTERNATIONAL REGULATORY REQUIREMENTS FOR BIOEQUIVALENCE

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9780849377853 ::  GENERIC DRUG PRODUCT DEVELOPMENT
ISBN:

9780849377853

Colección:DRUGS AND THE PHARMACEUTICAL SCIENCES
Volumen:201
EditorialTAYLOR & FRANCIS GROUP
Edicion:
Páginas:332
Idioma:INGLES
P.V.P.: 159,82 € + 4% IVA = 166,21 €
Dto 5% Ahorras 8,31 €
Importe final iva incl. 157,90 €
PLAZO DE ENTREGA 20 DIAS

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.

INTRODUCTIONISADORE KANFERAUSTRALASIAC. T.HUNG, D. REN, L. A. FOLLAND, F. C. LAM, NOELYN ANNEHUNG,AND R. SMARTBRAZILMARGARETH R. C. MARQUES, SILVIA STORPIRTIS, AND MARCIA MARTINI BUENOCANADAIAIN J. MCGILVERAYTHE EUROPEAN UNIONROGER K. VERBEECK AND JOELLE WARLININDIASUBHASH C. MANDAL AND S. RAVISANKARJAPANJUICHI RIKUSOUTH AFRICAISADORE KANFER, RODERICK B. WALKER, AND MICHAEL F. SKINNERSOUTH AMERICA AND PAN AMERICAN HEALTH ORGANIZATIONSILVIA SUSANA GIARCOVICH AND RICARDO BOLAÑOSTAIWANLI-HENG PAO, JO-FENG CHI, AND OLIVER YOA-PU HUTURKEYILKER KANZIK AND A. ATILLA HINCALUNITED STATES OF AMERICABARBARA M. DAVIT AND DALE P. CONNERTHEWORLD HEALTH ORGANIZATIONJOHN GORDON, HENRIKE POTTHAST, MATTHIAS STAHL, AND LEMBIT RAGO

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