Results 51 to 60 of about 3,618 (166)

Replacement, Reduction and Refinement of Animal Testing in the Quality Control of Human Vaccines [PDF]

, 2015
Vaccines are recognised as a highly cost effective tool for preventing infectious diseases. They are derived from biological sources and due to the complexity of composition and heterogeneity of products, vaccine lots undergo legally required quality ...
HALDER MARIA ELISABETH
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Shared knowledge centre (research and education centre) of the Peoples’ Friendship University of Russia as a modern experimental basis for the development of drug standards

Регуляторные исследования и экспертиза лекарственных средств, 2018
Shared Knowledge Centre (Research and Education Centre) of the Peoples’ Friendship University of Russia (SKC (REC) PFUR) was established in 2009. It is equipped with modern advanced measuring and testing equipment.
R. A. Abramovich, O. G. Potanina, V. V. Chistyakov, S. V. Goryainov, A. N. Vorobiev, A. V. Nikulin   +5 more
doaj  

Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use [PDF]

, 2011
Background The objective of this work was to study the vitamins B1, B2, B6 and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium ...
Daniela O Ribeiro, Daniela C Pinto, Luis Mauricio TR Lima, Nádia M Volpato, Lúcio M Cabral, Valéria P de Sousa   +5 more
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Approaches to Assessing the Quality of Fatty Oils and Medicinal Products Formulated as Oily Solutions

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Vegetable fatty oils can comprise over 50% of a medicinal product formulated as an oily solution (in some cases, 100%). The quality of the vegetable fatty oil used and the processes occurring in this oil have a significant impact on the ...
A. A. Ponomarenko, L. I. Panova
doaj   +1 more source

FDA Regulation and the New Anti-aging Products [PDF]

, 2012
In the decades since the enactment of the Federal Food, Drug, and Cosmetic Act (the "Act")' in 1938, one of the more persistent challenges facing the Food and Drug Administration (the "FDA") has been to apply an old statute to the regulatory problems ...
Hensel, Donald P.
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Accelerated dissolution testing for controlled release microspheres using the flow-through dissolution apparatus [PDF]

, 2008
Theophylline controlled release capsules (THEO-24 CR) were used as a model system to evaluate accelerated dissolution tests for process and quality control and formulation development of controlled release formulations.
Ahmed, Hisham, Capomacchia, A.C., Collier, Jarrod W., Granade, Saundra, Graner, Solomon T., Israel, Bridgette, Thakare, Mohan   +6 more
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History and current status of biological tests in Russia

Регуляторные исследования и экспертиза лекарственных средств, 2018
«Pyrogenicity» and «Abnormal Toxicity» are considered to be among most problematic pharmacopoeia monographs in the current editions of the leading world pharmacopoeias, the reasonability of which is not obvious to all experts.
M. S. Ryabtseva, T. A. Batuashvili, G. A. Sapozhnikova, N. P. Neugodova, Yu. V. Olefir, V. A. Merkulov   +5 more
doaj  

Review of the pharmacokinetics of French maritime pine bark extract (Pycnogenol®) in humans

Frontiers in Nutrition
The French maritime pine bark extract Pycnogenol® is a proprietary product from Pinus pinaster Aiton. It complies with the quality specifications in the United States Pharmacopeia monograph “Pine extract” in the section of dietary supplements. Pycnogenol®
Jasmin Bayer, Petra Högger
doaj   +1 more source

Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol). [PDF]

, 2006
Literature data are reviewed on the properties of acetaminophen (paracetamol) related to the biopharmaceutics classification system (BCS). According to the current BCS criteria, acetaminophen is BCS Class III compound.
Amidon, G L, Barends, Dirk M, Dressman, J B, Junginger, H E, Kalantzi, L, Midha, K K, Reppas, C, Shah, V P, Stavchansky, S A   +8 more
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Preclinical study of the efficacy and safety of wound healing gel containing chitosan, taurine and allantoin [PDF]

, 2017
Objectives: To develop gel containing chitosan, taurine, allantoin, and to experimentally investigate its wound healing properties in preclinical studies on laboratory ...
Buzlama, A. V., Chernov, Y. N., Fedosov, P. A., Nikolaevsky, V. A., Slivkin, A. I.   +4 more
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