Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Points-to-consider documents

Recent concerns over the arrhythmogenic effects of a number of marketed compounds have resulted in the issue of the Points to Consider document, CPMP 986/96 by the EMA (European Medicines Agency) (available at http //www.eudra/org/humandocs/PDFs/SWP/098696en.pdf). [Pg.744]

Cardiac Action Potential In Vitro Purkinje Fibers. Intracellular recording of action potentials from cardiac Purkinje fibers isolated from dog or sheep ventricle. Measurement of maximum rate of depolarization and action potential duration to detect sodium and potassium channel interactions, respectively, according to recommendations in EM A CPMP Points to Consider document, CPMP 986/96 (1998). [Pg.746]

In addition, the CPMP adopted in May 2002 a concept paper (CPMP/EWP/968/02) on a proposal to develop a CPMP Points to Consider document on the evaluation of the pharmacokinetics of medicinal products in the paediatric population. [Pg.508]

A few years ago, the Parenteral Drug Association (PDA) Task Force on Cleaning issued a Points to Consider document [10] that enumerated various types of s amplings currently in use in the industry. They were (at that time)... [Pg.273]

Note The term guideline is used here to refer to testing guidelines, Notes for guidance, as well as Points to consider documents. [Pg.80]

Items for Future Update of Japanese Points-to-Consider Document 107... [Pg.93]

Scientists from NIHS, PMDA, and JPMA collaborated to publish a Points-to-Consider document regarding the safety assessment of biopharmaceuticals in preclinical studies in 2002 [3], The collaboration team intended to clarify their interpretation of the ICH S6 guideline and share recent Japanese practices on this matter. However, it was written in Japanese. Thus the collaboration team made an English translation of the document and also collected comments on the contents from experts in the United States and the European. The experts agreed to most ideas presented in the Japanese Points-to-Consider document. They also suggested more clarification of some other ideas. In light of these comments, the collaboration team revised and published the English translation of the document, such that the nonnative Japanese could correctly understand the contents [4], In this section, I summarize the key points of the document, as they may be of some help to scientists in the pharmaceutical... [Pg.99]

Additional useful ideas included in the Japanese Points-to-Consider document are summarized that require further clarification. [Pg.103]

Points-to-Consider document helps industry scientists and regulatory reviewers understand the ICH S6 guideline. In particular, it is helpful for the clarification of case-by-case approaches to preclinical programs depending on the biopharmaceutical type. However, further updates of the Japanese Points-to-Consider document may be needed as newer types of biopharmaceuticals, technologies, and assays have developed. [Pg.109]

In 1997 the FDA issued an addendum to the original Points-to-Consider Document for Developing Monoclonal Antibodies. This document addressed... [Pg.114]

Tissue banks are the most common source of human tissues. While surgical biopsy accessions are preferred, they are limited in availability and often unavailable for many tissues (e.g., brain and other vital organs). Therefore the majority of tissue samples used in cross-reactivity studies are those acquired at autopsy. For autopsy accessions all efforts must be made to minimize the time interval between death and tissue collection. Information provided with specimens generally includes age, gender, and usually race and some clinical history and/or cause of death. As suggested in the Points-to-Consider document, the tissues used in a standard tissue cross-reactivity study are acquired from adults (>18 years of age). Pediatric tissues are often very difficult to obtain and are usually not used in a standard tissue cross-reactivity study unless there is a clear pediatric indication for the test article. [Pg.216]

EMEA. Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues, 2001. http //www.emea.europa.eu/pdfs/ human/swp/037201en.pdf... [Pg.513]


See other pages where Points-to-consider documents is mentioned: [Pg.714]    [Pg.229]    [Pg.60]    [Pg.64]    [Pg.248]    [Pg.118]    [Pg.492]    [Pg.79]    [Pg.93]    [Pg.94]    [Pg.99]    [Pg.99]    [Pg.100]    [Pg.100]    [Pg.101]    [Pg.103]    [Pg.105]    [Pg.107]    [Pg.107]    [Pg.120]    [Pg.217]    [Pg.556]   


SEARCH



Considered

© 2024 chempedia.info