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:
Generic drugs.
Drug development.
Drugs > Dosage forms.
Drugs > Therapeutic equivalency.
Drugs, Generic
Dosage Forms
Therapeutic Equivalency
Médicaments génériques.
Médicaments > Développement.
Médicaments > Formes pharmaceutiques.
Médicaments > Équivalence thérapeutique.
MEDICAL > Pharmacology.
Drug development
Drugs > Dosage forms
Drugs > Therapeutic equivalency
Generic drugs
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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
  • 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

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