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EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
The main differences between an estate liquidation and a mere estate sale is the sphere of inclusion which in a liquidation can expand to stocks, bonds, real property, fine jewelry, coin collections and fine art.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The auctioneer would give Texas the first chance the buy the used border wall materials, should they go back up for sale, Patrick wrote. "Governor (Greg) Abbott and I stand ready to buy them if ...
Bally Sports and its parent company, Diamond Sports Group, announced in a court filing on Nov. 9th that they had reached an agreement with their creditors to resolve any remaining issues for the ...
A Guideline Comparison utility that gives users the ability to generate side-by-side comparisons for any combination of two or more guidelines; Guideline Syntheses prepared by NGC staff, comparing guidelines covering similar topics, highlighting areas of similarity and difference.