Das Buch ist derzeit nicht auf Lager
Mehr zum Buch
Focusing on pharmaceutical equivalence and bioequivalence, this volume addresses the scientific and regulatory challenges faced by manufacturers of specialty drug products. It outlines the necessary approaches to demonstrate therapeutic equivalence between generic and brand-name drugs. Additionally, the book covers the assessment of drug product quality and performance, emphasizing the regulatory requirements for various delivery methods, including topical, nasal, inhalation, transdermal, as well as generic biologics and modified release parenteral products.
Buchkauf
Generic Drug Product Development, Leon Shargel, Isadore Kanfer
- Sprache
- Erscheinungsdatum
- 2010
Wir benachrichtigen dich per E-Mail.
Lieferung
Zahlungsmethoden
Feedback senden
- Titel
- Generic Drug Product Development
- Untertitel
- Specialty Dosage Forms
- Sprache
- Englisch
- Autor*innen
- Leon Shargel, Isadore Kanfer
- Verlag
- 2010
- Einband
- Hardcover
- Seitenzahl
- 288
- ISBN13
- 9780849377860
- Kategorie
- Technik & Maschinenbau, Ökologie, Biologie
- Beschreibung
- Focusing on pharmaceutical equivalence and bioequivalence, this volume addresses the scientific and regulatory challenges faced by manufacturers of specialty drug products. It outlines the necessary approaches to demonstrate therapeutic equivalence between generic and brand-name drugs. Additionally, the book covers the assessment of drug product quality and performance, emphasizing the regulatory requirements for various delivery methods, including topical, nasal, inhalation, transdermal, as well as generic biologics and modified release parenteral products.