Bioequivalence Requirements in Various Global Jurisdictions [[electronic resource] /] / edited by Isadore Kanfer |
Edizione | [1st ed. 2017.] |
Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 |
Descrizione fisica | 1 online resource (X, 345 p. 17 illus., 15 illus. in color.) |
Disciplina | 615.1901 |
Collana | AAPS Advances in the Pharmaceutical Sciences Series |
Soggetto topico |
Pharmaceutical technology
Pharmaceutical Sciences/Technology |
ISBN | 3-319-68078-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Brazil -- Canada -- China -- The European Union -- India -- Bioequivalence Studies in Japan -- Middle East and North Africa (MENA) Bioequivalence Requirements -- Russia -- South Africa -- The United States of America -- World Health Organization (WHO). |
Record Nr. | UNINA-9910253958103321 |
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
Descrizione fisica | 1 online resource (292 p.) |
Disciplina | 615.19 |
Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
Collana | Drugs and the pharmaceutical sciences |
Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
Soggetto genere / forma | Electronic books. |
ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
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 |
Record Nr. | UNINA-9910459270503321 |
New York : , : Informa Healthcare USA, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
Descrizione fisica | 1 online resource (292 p.) |
Disciplina | 615.19 |
Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
Collana | Drugs and the pharmaceutical sciences |
Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
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 |
Record Nr. | UNINA-9910792350103321 |
New York : , : Informa Healthcare USA, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
Descrizione fisica | 1 online resource (292 p.) |
Disciplina | 615.19 |
Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
Collana | Drugs and the pharmaceutical sciences |
Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
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 |
Record Nr. | UNINA-9910800062003321 |
New York : , : Informa Healthcare USA, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
Descrizione fisica | 1 online resource (292 p.) |
Disciplina | 615.19 |
Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
Collana | Drugs and the pharmaceutical sciences |
Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
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 |
Record Nr. | UNINA-9910828494103321 |
New York : , : Informa Healthcare USA, , 2010 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|