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100301s2010 xxu| s |||| 0|eng d |
| 020 ## - NÚMERO INTERNACIONAL NORMALIZADO PARA LIBROS |
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| International Standard Book Number |
9781441908896 |
| -- |
978-1-4419-0889-6 |
| 040 ## - FUENTE DE CATALOGACIÓN |
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| Transcribing agency |
MX-MeUAM |
| 050 #4 - SIGNATURA TOPOGRÁFICA DE LA BIBLIOTECA DEL CONGRESO |
|---|
| Classification number |
RM1-950 |
| 082 04 - NÚMERO DE CLASIFICACIÓN DECIMAL DEWEY |
|---|
| Classification number |
615 |
| Edition number |
23 |
| 100 1# - ASIENTO PRINCIPAL--NOMBRE PERSONAL |
|---|
| Personal name |
Huynh-Ba, Kim. |
| Relator term |
editor. |
| 245 10 - MENCIÓN DE TITULO |
|---|
| Title |
Pharmaceutical Stability Testing to Support Global Markets |
| Medium |
[recurso electrónico] / |
| Statement of responsibility, etc. |
edited by Kim Huynh-Ba. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
New York, NY : |
| Name of producer, publisher, distributor, manufacturer |
Springer New York, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2010. |
| 300 ## - DESCRIPCIÓN FÍSICA |
|---|
| Other physical details |
online resource. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 490 1# - MENCIÓN DE SERIE |
|---|
| Series statement |
Biotechnology: Pharmaceutical Aspects ; |
| Volume/sequential designation |
XII |
| 505 0# - NOTA DE CONTENIDO |
|---|
| Formatted contents note |
Section I -- Stability Studies in a Global Environment -- Regulatory Perspectives on Product Stability -- Current International Harmonization Efforts -- Update on the WHO Stability Guideline -- Development of a Regional Guideline for the Eastern Mediterranean Region -- The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India -- Requirements for South East Asian Markets -- The Role of USP Monographs in Stability Testing -- Regulatory Requirements for Stability Testing of Generics -- Stability Design for Consumer Healthcare Products -- Challenges of Drug/Devices Pharmaceutical Products -- Practical Challenges of Stability Testing of Nutraceutical Formulations -- Setting Tolerances for Instrument Qualification USP Chapter -- Technical Concepts for Stability Program -- The Concept of Quality-by-Design -- Forced Degradation and Its Relation to Real Time Drug Product Stability -- Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation -- Stability of Repackaged Products -- Packaging-Induced Interactions and Degradation -- An Overview of Physical Stability of Pharmaceuticals -- Stability of Split Tablets -- Temperature Monitoring During Shipment and Storage -- Introducing a Science-Based Quality by Design Concept to Analytical Methods Development -- Stability Data and Operational Practices -- Optimizing Stability Data Package to Facilitate NDA/MAA Approval -- Maximize Data for Post Approval Changes -- Use of Statistics to Establish a Stability Trend: Matrixing -- Setting Specifications for Drug Substances -- Setting Specifications for Drug Products -- Highlights of Investigating Out-of-Specifications Test Results -- Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs -- Building and Developing of Relationships with Third Party Laboratories -- Outsourcing Stability Testing: A Tool for Resource and Risk Management. |
| 520 ## - NOTA DE RESUMEN, ETC. |
|---|
| Summary, etc. |
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions. |
| 596 ## - |
|---|
| -- |
19 |
| 650 #0 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Medicine. |
| 650 #0 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Toxicology. |
| 650 14 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
| 650 24 - ASIENTO SECUNDARIO DE MATERIA - TERMINO TEMÁTICO |
|---|
| Topical term or geographic name as entry element |
Pharmacology/Toxicology. |
| 710 2# - ASIENTO SECUNDARIO - NOMBRE CORPORATIVO |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9781441908889 |
| 830 #0 - ASIENTO SECUNDARIO DE SERIE--TITULO UNIFORME |
|---|
| Uniform title |
Biotechnology: Pharmaceutical Aspects ; |
| Volume number/sequential designation |
XII |
| 856 40 - LOCALIZACIÓN Y ACCESO ELECTRÓNICOS |
|---|
| Public note |
Libro electrónico |
| Uniform Resource Identifier |
<a href="http://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-1-4419-0889-6">http://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-1-4419-0889-6</a> |
| 942 ## - TIPO DE MATERIAL (KOHA) |
|---|
| Koha item type |
Libro Electrónico |
