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GENERIC DRUG PRODUCT DEVELOPMENT

SPECIALTY DOSAGE FORMS

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9780849377860 ::  GENERIC DRUG PRODUCT DEVELOPMENT
ISBN:

9780849377860

Colección:DRUGS AND THE PHARMACEUTICAL SCIENCES
EditorialTAYLOR & FRANCIS GROUP
Edicion:
Páginas:288
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

<P><STRONG>GENERIC DRUG PRODUCT DEVELOPMENT: SPECIALTY DOSAGE FORMS</STRONG> 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. </P><P>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.</P><P>THE BOOK IS ESSENTIAL READING FOR SPECIALISTS AND RESEARCHERS IN PHARMACEUTICAL DRUG DEVELOPMENT, REGULATION, MANUFACTURING, AND OTHERS IN THE PHARMACEUTICAL SCIENCES. </P>

<P>INTRODUCTION, <I>LEON SHARGEL<BR></I>NONSYSTEMICALLY ABSORBED ORAL DRUG PRODUCTS, <I>MARC LEFEBVRE<BR></I>TOPICAL DRUG PRODUCTS—DEVELOPMENT, MANUFACTURE AND REGULATORY ISSUES, <I>MARY BETH G. ERSTAD AND CANDIS EDWARDS<BR></I>ASSESSMENT OF TOPICAL DOSAGE FORMS INTENDED FOR LOCAL OR REGIONAL ACTIVITY, <I>ISADORE KANFER, RALPH NII OKAI TETTEY-AMLALO, WAI LING AU, AND BETSY HUGHES-FORMELLA<BR></I>RECTAL DOSAGE FORMS AND SUPPOSITORIES, <I>K. ROSH VORA AND MOHAMMED N. ALICHISTY<BR></I>NASAL AND INHALATION DRUG PRODUCTS, <I>JOHN BELL AND PAUL FLANDERS<BR></I>LOCALLY ACTING NASAL AND INHALATION DRUG PRODUCTS: REGULATORY AND BIOEQUIVALENCE PERSPECTIVE, <I>GUR JAI PAL SINGH<BR></I>TRANSDERMAL DOSAGE FORMS, <I>MARIO A. GONZÁLEZ AND GARY W. CLEARY<BR></I>PHARMACEUTICAL DEVELOPMENT OF MODIFIED-RELEASE PARENTERAL DOSAGE FORMS USING BIOEQUIVALENCE (BE), QUALITY BY DESIGN (QBD), AND IN VITRO IN VIVO CORRELATION (IVIVC) PRINCIPLES, <I>SIDDHESH D. PATIL AND DIANE J. BURGESS<BR></I>BIOSIMILAR DRUG PRODUCTS—MANUFACTURE AND QUALITY, <EM>SUZANNE M. SENSABAUGH<BR></EM>INDEX </P>

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