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Generic Drug Product Development : Specialty Drug Forms.

Explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Shargel, Leon
Otros Autores: Kanfer, Isadore
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York : Informa Healthcare, 2010.
Temas:
Acceso en línea:Texto completo

MARC

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100 1 |a Shargel, Leon. 
245 1 0 |a Generic Drug Product Development :  |b Specialty Drug Forms. 
260 |a New York :  |b Informa Healthcare,  |c 2010. 
300 |a 1 online resource (292 pages) 
336 |a text  |b txt  |2 rdacontent 
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520 |a Explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. 
588 0 |a Print version record. 
505 0 |a Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products -- Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms 
505 8 |a Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products -- Manufacture and Quality ; Index; Color Insert ; Back Cover 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Generic drugs. 
650 0 |a Drug development. 
650 0 |a Drugs  |x Dosage forms. 
650 0 |a Drugs  |x Therapeutic equivalency. 
650 2 |a Drugs, Generic 
650 2 |a Dosage Forms 
650 2 |a Therapeutic Equivalency 
650 6 |a Médicaments génériques. 
650 6 |a Médicaments  |x Développement. 
650 6 |a Médicaments  |x Formes pharmaceutiques. 
650 6 |a Médicaments  |x Équivalence thérapeutique. 
650 7 |a MEDICAL  |x Pharmacology.  |2 bisacsh 
650 7 |a Drug development  |2 fast 
650 7 |a Drugs  |x Dosage forms  |2 fast 
650 7 |a Drugs  |x Therapeutic equivalency  |2 fast 
650 7 |a Generic drugs  |2 fast 
700 1 |a Kanfer, Isadore. 
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