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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.: 153,63 € + 4% IVA = 159,77 €
Dto 5% Ahorras 7,99 €
Importe final iva incl. 151,78 €
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.

<P>INTRODUCTION<BR><I>ISADORE KANFER<BR></I>AUSTRALASIA<BR><I>C. T.HUNG, D. REN, L. A. FOLLAND, F. C. LAM, NOELYN ANNEHUNG,<BR>AND R. SMART<BR></I>BRAZIL<BR><I>MARGARETH R. C. MARQUES, SILVIA STORPIRTIS, AND MARCIA MARTINI BUENO<BR></I>CANADA<BR><I>IAIN J. MCGILVERAY<BR></I>THE EUROPEAN UNION<BR><I>ROGER K. VERBEECK AND JOELLE WARLIN<BR></I>INDIA<BR><I>SUBHASH C. MANDAL AND S. RAVISANKAR<BR></I>JAPAN<BR><I>JUICHI RIKU<BR></I>SOUTH AFRICA<BR><I>ISADORE KANFER, RODERICK B. WALKER, AND MICHAEL F. SKINNER<BR></I>SOUTH AMERICA AND PAN AMERICAN HEALTH ORGANIZATION<BR><I>SILVIA SUSANA GIARCOVICH AND RICARDO BOLAÑOS<BR></I>TAIWAN<BR><I>LI-HENG PAO, JO-FENG CHI, AND OLIVER YOA-PU HU<BR></I>TURKEY<BR><I>ILKER KANZIK AND A. ATILLA HINCAL<BR></I>UNITED STATES OF AMERICA<BR><I>BARBARA M. DAVIT AND DALE P. CONNER<BR></I>THEWORLD HEALTH ORGANIZATION<BR><I>JOHN GORDON, HENRIKE POTTHAST, MATTHIAS STAHL, AND LEMBIT RAGO</I><BR></P>

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