Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

4 valoración promedio
( 2 valoraciones por Goodreads )
 
9780387856261: Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

"Sinopsis" puede pertenecer a otra edición de este libro.

From the Back Cover:

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

  • Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
  • Post-approval considerations and regulatory filing strategies to support a global supply chain.
  • Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
  • Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
  • Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
  • USP-NF testing in support of stability.
  • Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
  • Discussion of matrixing and bracketing to support reduced stability testing.
  • Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

About the Author:

Kim Huynh-Ba is Technical Director of Pharmalytik. She has over 20 years of experiences in various analytical areas of pharmaceutical development, especially in Stability Sciences. She has involved with several projects harmonizing or optimizing analytical best practices in several companies, including those are under Consent Decree. Ms. Huynh-Ba has authored numerous technical publications and book chapters. She is a frequent invited speaker at national and international conferences. She has conducted several training courses on stability compliance and quality issues for American Chemical Society, American Association of Pharmaceutical Scientists, Pharmaceutical Training Institute, Eastern Analytical Symposium since 2001. She is the founder of AAPS Stability Focus Group and actively involved with Pharmaceutical Stability Discussion Group. She is an active member of ACS, AAPS, PSDG, ASQ, POMA and serves in the Governing Board of Eastern Analytical Symposium (EAS).

In my professional career as a pharmaceutical scientist, I have been involved with several aspects of the drug development process from pre-IND to commercial and, somehow, I usually found myself coming back to a stability related issue. Stability area seems to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues was the same. Each situation posed challenges that usually required an exercise of judgment, an understanding of regulations, knowledge of science, a grasp of compliance, and an appreciation of common practices.

Since early 2000, I have also been involved with several training opportunities and I struggled to find good, concise, practical resources, one of which I can just hand to a new scientist who wishes to gain more understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums.

As a book lover, I also have a good collection of technical books. Unfortunately, most of the stability related books are outdated. In addition, many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changing rapidly while regulatory agencies are working closely with the pharmaceutical industry to accommodate these changes; however, the fundamental information continues to remain quite the same as current Good Manufacturing Practices (cGMP) continues to be the standard industry practice. Therefore, I hope to assemble a practical handbook to fill this void.

"Sobre este título" puede pertenecer a otra edición de este libro.

Los mejores resultados en AbeBooks

Edición internacional
Edición internacional

1.

BA HUYNH
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: 10
Edición internacional
Librería
bookscollection
(Delhi, DELHI, India)
Valoración
[?]

Descripción Estado de conservación: Brand New. HARDCOVER, Book Condition New, International Edition. We Do not Ship APO FPO AND PO BOX. Cover Image & ISBN may be different from US edition but contents as US Edition. Printing in English language.NO CD AND ACCESS CODE. Quick delivery by USPS/UPS/DHL/FEDEX/ARAMEX ,Customer satisfaction guaranteed. We may ship the books from Asian regions for inventory purpose. Nº de ref. de la librería ABEADH##4985

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 47,14
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 3,59
De India a Estados Unidos de America
Destinos, gastos y plazos de envío
Edición internacional
Edición internacional

2.

Editorial: Secaucus, New Jersey, U.S.A.: Springer Verlag (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: > 20
Edición internacional
Librería
University Bookstore
(DELHI, DELHI, India)
Valoración
[?]

Descripción Secaucus, New Jersey, U.S.A.: Springer Verlag, 2008. Hardcover. Estado de conservación: New. No Jacket. This book is BRAND NEW hard cover International edition with black and white printing. ISBN number and cover page may be different but contents identical to the US edition word by word. Book is in English language. Nº de ref. de la librería CBS18

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 74,91
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 10,01
De India a Estados Unidos de America
Destinos, gastos y plazos de envío

3.

Editorial: Springer-Verlag New York Inc., United States (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: 1
Librería
The Book Depository
(London, Reino Unido)
Valoración
[?]

Descripción Springer-Verlag New York Inc., United States, 2008. Hardback. Estado de conservación: New. Language: English . Brand New Book. In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations,a knowledgeof science, a graspof compliance,and an appreciation of common practices. Sinceearly2000,Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information.I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththep harmac- tical industryto accommodatethese changes;however,thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this void. Nº de ref. de la librería LIB9780387856261

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 163,15
Convertir moneda

Añadir al carrito

Gastos de envío: GRATIS
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

4.

Editorial: Springer-Verlag New York Inc., United States (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: 1
Librería
The Book Depository US
(London, Reino Unido)
Valoración
[?]

Descripción Springer-Verlag New York Inc., United States, 2008. Hardback. Estado de conservación: New. Language: English . Brand New Book. In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations,a knowledgeof science, a graspof compliance,and an appreciation of common practices. Sinceearly2000,Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information.I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththep harmac- tical industryto accommodatethese changes;however,thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this void. Nº de ref. de la librería LIB9780387856261

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 163,88
Convertir moneda

Añadir al carrito

Gastos de envío: GRATIS
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

5.

Kim Huynh-Ba
Editorial: Springer-Verlag New York Inc. (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Cantidad: > 20
Impresión bajo demanda
Librería
Pbshop
(Wood Dale, IL, Estados Unidos de America)
Valoración
[?]

Descripción Springer-Verlag New York Inc., 2008. HRD. Estado de conservación: New. New Book.Shipped from US within 10 to 14 business days.THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Nº de ref. de la librería IP-9780387856261

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 163,26
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 3,41
A Estados Unidos de America
Destinos, gastos y plazos de envío

6.

Huynh-Ba, Kim
Editorial: Springer (2016)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Paperback Cantidad: 1
Impresión bajo demanda
Librería
Ria Christie Collections
(Uxbridge, Reino Unido)
Valoración
[?]

Descripción Springer, 2016. Paperback. Estado de conservación: New. PRINT ON DEMAND Book; New; Publication Year 2016; Not Signed; Fast Shipping from the UK. No. book. Nº de ref. de la librería ria9780387856261_lsuk

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 165,12
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 4,33
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

7.

Huynh-Ba, Kim
Editorial: Springer-Verlag New York Inc. (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Cantidad: > 20
Impresión bajo demanda
Librería
Books2Anywhere
(Fairford, GLOS, Reino Unido)
Valoración
[?]

Descripción Springer-Verlag New York Inc., 2008. HRD. Estado de conservación: New. New Book. Delivered from our US warehouse in 10 to 14 business days. THIS BOOK IS PRINTED ON DEMAND.Established seller since 2000. Nº de ref. de la librería IP-9780387856261

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 165,83
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 10,07
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

8.

KIM HUYNH-BA
Editorial: Springer (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: 1
Librería
Herb Tandree Philosophy Books
(Stroud, GLOS, Reino Unido)
Valoración
[?]

Descripción Springer, 2008. Hardback. Estado de conservación: NEW. 9780387856261 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Nº de ref. de la librería HTANDREE0274881

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 174,93
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 8,95
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

9.

Kim Huynh-Ba (editor)
Editorial: Springer New York 2008-11-21, New York |London (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: > 20
Librería
Blackwell's
(Oxford, OX, Reino Unido)
Valoración
[?]

Descripción Springer New York 2008-11-21, New York |London, 2008. hardback. Estado de conservación: New. Nº de ref. de la librería 9780387856261

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 185,88
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 3,36
De Reino Unido a Estados Unidos de America
Destinos, gastos y plazos de envío

10.

Kim Huynh-Ba (Editor)
Editorial: Springer (2008)
ISBN 10: 0387856269 ISBN 13: 9780387856261
Nuevos Tapa dura Cantidad: 1
Impresión bajo demanda
Librería
Ergodebooks
(RICHMOND, TX, Estados Unidos de America)
Valoración
[?]

Descripción Springer, 2008. Hardcover. Estado de conservación: New. 2009. This item is printed on demand. Nº de ref. de la librería DADAX0387856269

Más información sobre esta librería | Hacer una pregunta a la librería

Comprar nuevo
EUR 193,62
Convertir moneda

Añadir al carrito

Gastos de envío: EUR 3,41
A Estados Unidos de America
Destinos, gastos y plazos de envío

Existen otras copia(s) de este libro

Ver todos los resultados de su búsqueda