Generic drug product development
Subtitle: specialty dosage forms
By: edited by Leon Shargel, Isadore Kanfer.
Contributors: Shargel, Leon, 1941-; Kanfer, Isadore.
Series: Drugs and the pharmaceutical sciences -- 204; Drugs and the pharmaceutical sciences -- v. 204.
Publisher: Informa Healthcare USA
Published: 2010
Place of publication: New York
Language: eng
ISBN-13: 9780849377860
Subjects: Generic drugs; Drug development; Drugs -- Dosage forms; Drugs -- Therapeutic equivalency; Dosage Forms; Drugs, Generic; Biopharmaceutics -- methods; Therapeutic Equivalency
Notes: Includes bibliographical references and index.
Table of contents: title: Introduction : specialty dosage forms / Leon Shargel; title: Nonsystemically absorbed oral drug products / Marc Lefebvre; title: Topical drug products : development, manufacture, and regulatory issues / Mary Beth G. Erstad and Candis Edwards; title: Assessment of topical dosage forms intended for local or regional activity / Isadore Kanfer ... [et al.]; title: Rectal dosage forms and suppositories / K. Rosh Vora and Mohammed N. AliChisty; title: Nasal and inhalation drug products / John Bell and Paul Flanders; title: Locally acting nasal and inhalation drug products : regulatory and bioequivalence perspective / Gur Jai Pal Singh; title: Transdermal dosage forms / Mario A.González and Gary Cleary; title: Pharmaceutical development of modified-release parenteral dosage forms using bioequivalence (BE), quality by design (QBD), and in vitro in vivo correlation (IVIVC) principles / Siddhesh D. Patil and Diane J. Burgess; title: Biosimilar drug products; title: manufacture and quality / Suzanne M. Sensabaugh.