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Regulation of the synthesis and release of slow-reacting substance of anaphylaxis from sensitized monkey lung.
TLDR
A potential role for LTD in regulating the amount of SRS-A released from monkey lung is demonstrated and significant inhibition was observed at 150 ng/ml, which, in part, may have been produced by metabolism to leukotriene D4.
Immunologic mediator release from rhesus and cynomolgus monkey lung.
TLDR
It is demonstrated that the cynomolgus monkey can be used as a substitute for the rhesus monkey in immediate-type hypersensitivity reactions and quantitation of this endogenous reaginic reactivity suggested the presence of a high incidence of “allergic” animals among the monkey population.
Monitoring Outcomes of Pregnancy Following Drug Exposure
TLDR
Pregnancy registries can be used to review human exposure data in a systematic fashion so that useful information can be shared with women and their healthcare providers, and the strength of the registry lies in its ability to gather pregnancy outcome reports early in the life of a product and to recognise and analyse unusual birth defects.
The Art and Science of Risk Management
TLDR
There is a need to move the focus of risk management from the post-approval arena to earlier in the development process and tools need to be developed to support risk management throughout the lifecycle of a drug.
Immunologic histamine release in vitro from the heart and lung of the cynomolgus monkey.
TLDR
It is demonstrated that ventricular histamine may be immunologically released and that this release process can be pharmacologically inhibited in a manner similar to that of pulmonary tissue.
Gastric antisecretory 9H-xanthen-9-amines.
TLDR
It is hypothesized that this series of 9H-xanthen-9-amines possessing a wide variety of nitrogen substituents at C-9 is either rapidly bound to tissue and/or metabolized to an active species.
Reporting and Tracking Spontaneous Adverse Experience Reports via a Computer Database
Creation of a computerized document tracking system utilizing a FOCUS software package provides the user with a means of verifying the receipt and transmission of safety information within and
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