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This document discusses using size exclusion chromatography coupled with Fourier transform infrared spectroscopy (SEC/GPC-FTIR) to characterize pharmaceutical copolymer excipients. Specifically:
1. GPC-IR can analyze copolymer compositional drifts across molecular weight distributions by measuring functional group ratios.
2. It is useful for characterizing lot-to-lot and grade-to-grade variations in polymeric excipients from different manufacturing processes.
3. Case studies on copovidone and HPMCAS excipients show how GPC-IR detects compositional differences between samples and grades.
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This document discusses various types of pharmaceutical excipients used in compounding dosage forms. It lists 16 important excipients including antioxidants, preservatives, acidifying agents, and alkalizing agents. Details are provided on the chemistry, physical properties and uses of some specific excipients including ascorbic acid, BHA, chlorobutanol, sodium bicarbonate and sodium carbonate. Excipients are added to drugs to provide suitable consistency or form and aid in compounding pharmaceutical products.
China pharmaceutical excipients industry indepth research and investment stra...Qianzhan Intelligence
This document provides an overview and analysis of the pharmaceutical excipients industry in China. Some key points:
- The quality of excipients directly impacts the quality of drug preparations. The development of excipients lags behind China's pharmaceutical industry.
- The report analyzes the industry's development environment, status, competition and provides forecasts. It also examines international industry highlights and compares excipients in China and abroad.
- Major sections include an industry overview, development environment, international overview, China's industry development and competition, development models, and segment market analysis.
This document discusses various types of pharmaceutical excipients used in drug formulations. It defines excipients as pharmacologically inactive substances formulated alongside active pharmaceutical ingredients. Excipients provide bulk, facilitate drug absorption and stability, aid manufacturing, and improve handling. Common excipients include fillers, binders, disintegrants, coatings, preservatives, antioxidants, and solvents. Each excipient type has distinct functions and ideal properties. Proper excipient selection is important to ensure drug efficacy, stability, safety, and to avoid complications.
Copyright fair use and libraries madhu nlsiu and gaganMadhu Ks
Fair use exceptions in copyright law facilitate the use of copyrighted works for the purpose of research and education. These exceptions protect the academic community from the offence of copyright infringement. Fair use exceptions are limitations on copyright law and have helped librarians in carrying out their work of dissemination of knowledge. This paper discusses the various theories that support copyright protection and the need for fair use. By analysing the fair use exceptions under Indian Copyright Act, 1957 that are relevant to libraries, this paper takes a view that the law needs to provide better protection for libraries in matters of fair use.
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HPLC2010 Pharmaceutical Copolymer Excipient Characterization By GPC-FTIRmzhou45
This document discusses using size exclusion chromatography coupled with Fourier transform infrared spectroscopy (SEC/GPC-FTIR) to characterize pharmaceutical copolymer excipients. Specifically:
1. GPC-IR can analyze copolymer compositional drifts across molecular weight distributions by measuring functional group ratios.
2. It is useful for characterizing lot-to-lot and grade-to-grade variations in polymeric excipients from different manufacturing processes.
3. Case studies on copovidone and HPMCAS excipients show how GPC-IR detects compositional differences between samples and grades.
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This document outlines Good Manufacturing Practices (GMP) for pharmaceutical excipients. It provides minimum requirements for GMP applicable to all excipients. The principles aim to achieve excipient quality, establish control of manufacturing processes, and facilitate continual improvement. Key elements include quality management system requirements, documentation control, management responsibility and review. The GMP principles are intended to ensure excipients meet quality attributes necessary for drug products and regulatory standards.
This document discusses various types of pharmaceutical excipients used in compounding dosage forms. It lists 16 important excipients including antioxidants, preservatives, acidifying agents, and alkalizing agents. Details are provided on the chemistry, physical properties and uses of some specific excipients including ascorbic acid, BHA, chlorobutanol, sodium bicarbonate and sodium carbonate. Excipients are added to drugs to provide suitable consistency or form and aid in compounding pharmaceutical products.
China pharmaceutical excipients industry indepth research and investment stra...Qianzhan Intelligence
This document provides an overview and analysis of the pharmaceutical excipients industry in China. Some key points:
- The quality of excipients directly impacts the quality of drug preparations. The development of excipients lags behind China's pharmaceutical industry.
- The report analyzes the industry's development environment, status, competition and provides forecasts. It also examines international industry highlights and compares excipients in China and abroad.
- Major sections include an industry overview, development environment, international overview, China's industry development and competition, development models, and segment market analysis.
This document discusses various types of pharmaceutical excipients used in drug formulations. It defines excipients as pharmacologically inactive substances formulated alongside active pharmaceutical ingredients. Excipients provide bulk, facilitate drug absorption and stability, aid manufacturing, and improve handling. Common excipients include fillers, binders, disintegrants, coatings, preservatives, antioxidants, and solvents. Each excipient type has distinct functions and ideal properties. Proper excipient selection is important to ensure drug efficacy, stability, safety, and to avoid complications.
Copyright fair use and libraries madhu nlsiu and gaganMadhu Ks
Fair use exceptions in copyright law facilitate the use of copyrighted works for the purpose of research and education. These exceptions protect the academic community from the offence of copyright infringement. Fair use exceptions are limitations on copyright law and have helped librarians in carrying out their work of dissemination of knowledge. This paper discusses the various theories that support copyright protection and the need for fair use. By analysing the fair use exceptions under Indian Copyright Act, 1957 that are relevant to libraries, this paper takes a view that the law needs to provide better protection for libraries in matters of fair use.
Presentation to British Library re WIPO treaty for librariesEllen Broad
This document summarizes IFLA's work at the World Intellectual Property Organisation (WIPO) to advocate for exceptions and limitations for libraries and archives in international copyright law. It discusses IFLA's model library treaty, views expressed by different countries at WIPO, and challenges libraries face as copyright law has increasingly focused on protecting rights holders over the public interest in access to knowledge. The next WIPO committee meeting will discuss libraries exceptions amid ongoing debate between broadcasters and libraries.
This document discusses enabling online access to out-of-commerce works held by cultural heritage institutions through exceptions in copyright law. It notes that the current EU copyright rules are not adapted for online access. Cultural heritage institutions have asked for exceptions that would allow them to make out-of-commerce works in their collections available online and make works available onsite through devices visitors bring. The main challenge is developing language for an exception that allows cultural heritage institutions to fulfill their role of providing access online without impacting rights holders and publishers.
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1) The document discusses a study on the needs of differently-abled learners for virtual library services. It analyzes current library services for the differently-abled in Kolkata, which are found to be lacking.
2) The National Virtual Library project aims to aggregate digital resources from across India and make them accessible online to all. For differently-abled learners, it could provide resources in accessible formats and assistive technologies not available in traditional libraries.
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This ppt covers:
The Background
Copyright Laws/Practices in General
Licensing Terms & Agreements for E-Resources
Creative Commons and Open Access Rights
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Summing up
Presentació de Lluís M. Anglada, director de l'Àrea de Biblioteques, Informació i Documentació del CSUC, a l'International Coalition of Library Consortia (ICOLC), que va tenir lloc del 20 al 22 d'octubre de 2014 a la Biblioteca Nacional de Portugal.
En aquesta presentació, que formava part del bloc dedicat a noves eines, Anglada presenta el nou sistema integrat de biblioteques i eines de descobriment com a oportunitats per als consorcis.
1. Paul Otlet envisioned a "World City" in the early 20th century that would serve as a central repository of all the world's information, anticipating concepts like hyperlinks and search engines.
2. Otlet's Mundaneum project in Belgium aimed to interconnect all knowledge in an organized, universal system accessible to all. It brought together functions of a library, museum, and archive.
3. The modern Helsinki City Library has embraced digital technologies and services, aiming to be a "boundless library" that serves users locally and globally through physical and virtual access to information.
This document discusses digital libraries and includes the following key points:
1. It provides definitions of digital libraries, describing them as organized collections of digital information that can be accessed online.
2. It summarizes the history of digital libraries in 4 stages from early prototypes to current converged systems, noting pioneers like Vannevar Bush and developments like the creation of online catalogs.
3. It briefly describes 3 types of digital libraries: stand-alone, federated, and harvested, explaining their characteristics around centralized vs distributed content.
4. It discusses access management and security for digital libraries, covering authentication, authorization, integrity, and policies around licensing and usage rights.
This document discusses intellectual property as it relates to intangible cultural heritage (ICH). It defines various types of intellectual property like copyrights, patents, trademarks, geographical indications, and sui generis systems. It explains how intellectual property protections can help communities benefit from and safeguard their ICH by protecting their rights and preventing misuse. Traditional knowledge databases and ICH inventories are also discussed, noting they have different aims and require addressing rights management. Examples are provided of how communities have utilized intellectual property to control use and distribution of their cultural heritage.
This presentation discusses intellectual property as it relates to intangible cultural heritage (ICH). It defines various types of intellectual property like copyrights, patents, trademarks, geographical indications, and sui generis systems. It explains how intellectual property protections can help safeguard ICH and support sustainable development by protecting community rights and preventing misuse of their heritage. Traditional knowledge databases and ICH inventories are also discussed as tools to document cultural heritage, though care must be taken to respect community consent and ownership over such cultural documentation.
Library Automotion in India and Co-opertive between Library and Communityprofessionalpanorama
1) Library automation efforts began in India in the 1960s using punch cards and early computers to automate routines. 2) Early experiments with library automation included developing cataloging and classification systems at institutions like IIT Kanpur and ATIRA. 3) As computers advanced, more libraries explored automation applications like bibliographic databases, current awareness services, and digital libraries to improve efficiency and services.
Library automation in india and co operationTapasya123
Mechanisation was aimed at handling problems of bulk, weight and distance at replacing
muscle and movement with machines. This is the name given to an automatic system
of working. The difference between both automation and mechanization is mainly one
of degree. The automatic handling of parts between progressive production processes
in relation to engineering industries.
This document discusses the changing role of libraries and how their design can support new functions. It notes that libraries now incorporate cafes, health centers, and other services beyond books. New designs create flexible shared spaces to accommodate various activities from book groups to IT training. Technologies like wireless access and self-service options are becoming integral parts of libraries. The document also emphasizes the continued importance of libraries in fostering social interaction, lifelong learning, and cultural preservation for their communities.
The document outlines the programme for the fourth edition of the Internet Researchers' Conference (IRC19) being held from January 30 to February 1, 2019 in Hyderabad, India. The conference theme is "#List" and will include sessions exploring various dimensions of lists, such as their social, cultural and political implications. Some of the sessions listed include "#StoriesRecordsLegendsRituals", "#ListInterface", "#LegitLists", "#FOMO", "#CallingOutAndIn" and "#LoSHAandWhatFollowed".
The nine-judge bench was constituted to decide whether privacy is a fundamental right under the Indian Constitution, as earlier judgments like MP Sharma and Kharak Singh had denied its existence. The Attorney General had argued before a five-judge bench that these judgments were binding as they were decided by larger benches. However, petitioners argued that the observations on privacy in these cases were not relevant to the core issues decided, and that the view of mutual exclusivity of rights was overturned later. The nine-judge bench unanimously held that privacy is a fundamental right, upholding the view that rights must be given an expansive interpretation.
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Nehaa Chaudhari - The Library Exception / NLSIU, 04.03.2016
1. -Nehaa Chaudhari
The Centre for Internet and Society
CIS : Website - cis-india.org | Twitter - @cis-india
PERSONAL : Email - nehaa[at]cis-india[dot]org |Twitter- @nehaachaudhari
1
This presentation is available under a CC-BY-NC-SA 4.0 licence
2. Thelibraries
What are libraries?
Are there different
kinds/categories of libraries?
What is the role of libraries?
Do libraries perform
important socio-economic-
political functions?
What are some of the
challenges faced by libraries?
Thelaw
Does the law influence the
functioning of libraries?
Does the law limit the
functioning of libraries?
Can the law enable the
libraries to better perform
their functions?
Can the law help libraries
overcome their challenges?
Is there a gap between the
reality/practice of the
functioning of libraries, and
the law?
2
3. • Institutions that preserve + enable access to knowledge
and information, cultural heritage
• S. Ranganathan and the Five Laws of Library Science (1931)
• 50,000-60,000 public libraries in India
• UNESCO‟s Public Library Manifesto – “local gateway to
knowledge” + “living force for education, culture and
information” (Prashant Iyengar, 2010)
• The role of libraries is crucial at the juncture of the interests
of rights holders and, the interests of other stakeholders
(students, teachers, general public, researchers ++) in
accessing knowledge and information
The libraries
3
4. • Types:
• Based on form of institution (Public v. private v.
institutional (university etc.))
• Based on physical form (Brick and mortar v. digital)
• Based on type of content (Print v. digital)
• Based on economic incentive/business model
(commercial/for profit v. non commercial/not for
profit)
• What challenges do libraries face?
More about libraries
4
5. • Digital Libraries?
• Ease of replicating
• Ease of transmitting
• Ease of accessibility
• Simultaneous accessibility by multiple users
• Ease of manipulation/modification – questions on integrity
of works?
• New kinds of search/linking
• Ease of preservation/storage
• Ease of acquiring
• ….
Libraries and the digital
5
6. • Establishment – Public Libraries legislation
• In different states
• “So far, only half of the States of the Indian Union have successfully
passed the library legislation, However, in the coming few years, there is
greater possibility for a library law being enacted in the remaining States.
Out of these the enactment of Public Library Law at Puducherry State is
in the forefront.” (National Mission on Libraries, at
http://www.nmlindia.nic.in/pages/display/24)
• Legislation available for Andhra Pradesh, Gujarat, Harayana, Kerala,
Manipur, Mizoram, Orissa, Rajasthan, Tamil Nadu, Uttar Pradesh, West
Bengal, Chhatisgarh, Bihar, Maharashtra, Arunachal Pradesh (National
Mission on Libraries, at http://www.nmlindia.nic.in/pages/display/26)
The law
6
7. •Book “includes”
•Volume + parts of volumes + newspapers + serial publications + periodicals + manuscripts
| In any language
•Sheet of music/map/chart/plan separately printed or lithographed
•Audio and visual materials | Different format are listed including computer, photographs
etc.
•Public library “means”
•A library
•Established and maintained by the State Government/Local body/other organization
receiving aid from the State Government
•Declared open to the public
•Includes any other library recognised by notification by the State Government
•Aided library
•Library
•Declared as such by the state government
•Establishes one State Central Library + one State Reference Library + one Government
District Library in each district | Defines functions for all of them
Chattisgarh Public Libraries Act, 2008
7
8. Copyright law understanding is important for
libraries
Robust limitations and exceptions, i.e., fair dealing
provisions are crucial for libraries to perform their
functions
Certain acts not to be infringement of copyright” –
Section 52, The Copyright Act, 1957
52(1) The following acts shall not constitute an
infringement of copyright…
8
9. 52(1)(i): The reproduction of any work-
◦ (i) by a teacher or a pupil in the course of instruction; or
◦ (ii) as part of the questions to be answered in an
examination; or
◦ (iii) in answers to such questions
52(1)(j) Performance, in the course of the
activities of an educational institution of
[different categories of work….] by
[staff/students] if the audience is limited to
staff/students/parents/guardians/persons
connected with activities of the institution (i.e.,
audience limited)
9
10. 52(1)(p): The reproduction for the purpose of research
or private study, or, with a view to publication, of an
unpublished literary, dramatic or musical works (sic)
kept in a library, museum or other institutions to
which the public has access.
PROVIDED
◦ If identity of (any of the) author(s) is known to the institution,
this clause applies only if reproduction is made 60 years after
the date of the death of the author(s) [whose identity is
known]
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11. 52(1)(zb): The adaptation, reproduction, issue of copies or
communication to the public of any work in any
accessible format, by-
◦ (i) any person
To facilitate persons with disabilities to ACCESS works
Includes sharing of accessible format with any person with disability
for private/personal use, educational use or research
Commercial uses excluded
◦ (ii) any organization
working for the benefit of persons with disabilities
IN CASE THE NORMAL FORMAT PREVENTS THE ENJOYMENT
OF SUCH WORKS BY SUCH PERSONS
Provided
Copies are made available on a non profit basis. Only costs may be
recovered
Organization has to ensure that copies are used ONLY by persons with
disabilities AND take reasonable steps to prevent entry into ‘ordinary
channels of business’
11
12. 52(1)(n): the storing of a work in any medium by
electronic means by a non-commercial public
library, for preservation if the library already
possesses a non-digital copy of the work;
52(1)(o): the making of not more than three
copies of a book (including a pamphlet, sheet of
music, map, chart or plan) by or under the
direction of the person in charge of a [non-
commercial public library] for the use of the
library if such book is not available for sale in
India;
12
13. Multiple stakeholders
Limitation or exception
to copyright
Limitation or exception
is for limited uses,
limited audience, limited
actors capable of
exercising
Limitation or exception
is often subject to
further
conditions/provisos
Limitation or exception
is typically for non
commercial purposes
13
14. Three-step test
◦ In the Berne Convention, Article 9(2)
It shall be a matter of legislation
In certain special cases (step 1)
Provided that the reproduction does not conflict with the normal exploitation
of the work (step 2)
And does not unreasonably prejudice the legitimate interests of the author
◦ In the TRIPS Agreement, Article 13 (made the requirement to confine to
the three step test more stringent than in the Berne Convention)
Members SHALL CONFINE limitations or exceptions
To certain special cases (step 1)
Which do not conflict with the normal exploitation of the work (step 2)
And do not unreasonably prejudice the legitimate interests of the right
holder
◦ Marrakesh Treaty – „compromise language‟
◦ Proposed instrument on limitations and exceptions for libraries and
archives (WIPO-SCCR)
14
15. 15
Certain special cases (Step 1)
By a non commercial public library, to store
work
No conflict with the normal exploitation of
the work (Step 2)
For the purposes of preservation
Ensure legitimate interests of the right holder
are not unreasonably prejudiced (Step 3)
Provided the library already has a non digital
copy of the work
16. 16
Certain special cases (Step 1)
By a non commercial public library + Not more
than three copies of a book may be made
No conflict with the normal exploitation of the
work (Step 2)
For the use of the library
Ensure legitimate interests of the right holder
are not unreasonably prejudiced (Step 3)
If such book is not available for sale in India
17. 17
ON PRESERVATION – Section 52(1)(n)
Who can exercise the limitation and exception?
◦ Libraries
All libraries?
◦ No. Only NON COMMERCIAL PUBLIC LIBRARIES (under both – Section 52(1)(n) and Section
52(1)(o)
What is a library?
◦ No definition in the Copyright Act, 1957
◦ Source from public library legislations? But, these are different in every state; and, the Copyright
Act is a central legislation.
So, what CAN libraries do?
◦ Libraries can store material in electronic means
(From above ) Great! So, can libraries store any/all material in electronic form?
◦ No. They can only do so if they ALREADY POSSESS A NON DIGITAL COPY OF THE WORK.
(i.e., libraries are allowed to digitize existing collections)
(From above ) Alright, so what can libraries do with this digitized material?
◦ Libraries are allowed to make copies for PRESERVATION
◦ Strange. Does preservation include access? (Prashant Iyengar argues that it does)
◦ Preservation is only one part of what libraries do!
◦ Libraries also help other legitimate stakeholders exercise their legitimate limitations and
exceptions. (E.g. teachers and students in universities).
◦ If the library exception is curtailed, are other limitations and exceptions also curtailed?
18. 18
ON MAKING COPIES– Section 52(1)(o)
Who can exercise the limitation and exception?
◦ Libraries
All libraries?
◦ No. Only NON COMMERCIAL PUBLIC LIBRARIES (under both – Section 52(1)(n) and Section 52(1)(o)
What is a library?
◦ No definition in the Copyright Act, 1957
◦ Source from public library legislations? But, these are different in every state; and, the Copyright Act is a central
legislation.
So, what CAN libraries do?
◦ Libraries can make copies of a book
What is a book?
◦ No definition in the Copyright Act, 1957
◦ Source from public library legislations? These definitions include audio-visual material But, these are different in every
state; and, the Copyright Act is a central legislation.
◦ Does it cover material that is ‘born digital’?
(From above ) So, how many copies can libraries make?
◦ Not more than three copies
(From above ) Alright, so what can libraries do with these copies?
◦ Copies are permitted for ‘the use of the library’
◦ PROVIDED that the book is not available for sale in India
So, what does ‘available for sale in India’ mean?
◦ Does it (now) cover e-retailers?
◦ Absolute interpretation – sale at any price v. Reasonable interpretation – sale at a reasonable price? (See Lawrence Liang,
and, also, Prashant Iyengar)
19. Anti circumvention provisions
◦ Do not cease on the expiry of the term of copyright protection
◦ Cannot distinguish between legitimate and illegal uses
Licensing agreements with overriding effects?
File format migration and preservation
Legitimate fair dealing/fair use by end users blocked?
Cross border issues : Interoperability of national
limitations and exceptions
Different nations have differing standards and
definitions
WIPO Treaty on Limitations and Exceptions for
Libraries and Archives?
19
20. The content in this presentation is sourced from the
following material, and, is recommended reading on this
issue.
◦ Prashant Iyengar, The Library Exception under the Indian
Copyright Act, 1957, available at:
http://ssrn.com/abstract=1555718
◦ Lawrence Liang, Exceptions and Limitations in Indian Copyright
Law for Education: An Assessment, in the Law and Development
Review (2010), Volume 3, Issue 2, page 196/197 onwards.
◦ Ujwala Uppalpuri, The Libraries Exception: What the Amended
Copyright Act does (and should do) for Preserving and Sharing
Knowledge in the Digital Era, 5 NUJS L.Rev. 665 (2012)
◦ Kenneth Crews, Study on Limitations and Exceptions for
Libraries and Archives, available at:
http://www.wipo.int/edocs/mdocs/copyright/en/sccr_29/sccr
_29_3.pdf
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21. 21
- Nehaa Chaudhari
The Centre for Internet and Society
CIS : Website - cis-india.org | Twitter - @cis-india
PERSONAL : Email - nehaa[at]cis-india[dot]org |Twitter- @nehaachaudhari