Results 31 to 40 of about 3,107,552 (340)

Safety of Use of Russian Biosimilars of Interferon Beta-1b in the Treatment of Multiple Sclerosis: a Meta-analysis of Original Studies

Безопасность и риск фармакотерапии, 2019
Presently, an active search for  modern drugs for  the  treatment of multiple sclerosis is ongoing. Since  the  treatment with original drugs is expensive, therefore, the  development of local biosimilars is underway, which at a lower  cost should be ...
D. O. Gudz, A. E. Krasnov, R. N. Mamleev, R. K. Kagirov, M. L. Maximov   +4 more
doaj   +1 more source

A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY

Рациональная фармакотерапия в кардиологии, 2016
Aim. To study the clinical equivalence of original and generic drugs of bisoprolol in patients with arterial hypertension (HT) 1-2 degrees according to protocol recommended by the Society of Cardiology of the Russian Federation for comparative studies ...
S. Yu. Martsevich, S. N. Tolpygina, V. P. Voronina, O. V. Lerman, Yu. V. Lukina, N. A. Dmitrieva, I. V. Vashurina   +6 more
doaj   +1 more source

Current Approaches to Demonstration of Therapeutic Equivalence of Locally-Acting Gastrointestinal Drugs

Регуляторные исследования и экспертиза лекарственных средств, 2021
Evolution of knowledge about pharmacokinetics and pharmacodynamics of locally acting products, and an increase in the number of generics and medicines under development have laid the ground for the development of new scientific approaches to planning and
E. V. Gorbunova, D. V. Goryachev, T. E. Gorskaya, A. N. Bogdanov   +3 more
doaj   +1 more source

Guidelines for the recording and evaluation of pharmaco-EEG data in man: the International Pharmaco-EEG Society (IPEG) [PDF]

, 2012
The International Pharmaco-EEG Society (IPEG) presents updated guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-EEG data in man.
BABILONI, CLAUDIO, Boeijinga PH, Brunovsky M, Drinkenburg WH, Ffytche DH, Freeman J, Hegerl U, Hirata K, IPEG Pharmaco EEG Guidelines C.o.m.m.i.t.t.e.e. Collaborators, Jobert M, Kinoshita T, Knott VJ, Lopes Da Silva FH, Matousek M, Mucci A, Nottage JF, Olbrich S, Prichep LS, Ruigt GS, Saletu B, Stancak A, Strik WK, van Gerven JM, Wilson FJ, Wise RG   +24 more
core   +1 more source

Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study.

Urologic oncology, 2018
BACKGROUND This multicenter, randomized, open-label, active-controlled study evaluated therapeutic equivalence, steady-state pharmacokinetics, and safety of a novel abiraterone acetate fine particle formulation (AAFP) 500mg plus methylprednisolone vs ...
C. Stein, R. Levin, R. Given, C. Higano, Paul Nemeth, Bill Bosch, Jillian Chapas-Reed, R. Dreicer   +7 more
semanticscholar   +1 more source

Retroviral replicating vector-mediated gene therapy achieves long-term control of tumor recurrence and leads to durable anticancer immunity. [PDF]

, 2017
BackgroundProdrug-activator gene therapy with Toca 511, a tumor-selective retroviral replicating vector (RRV) encoding yeast cytosine deaminase, is being evaluated in recurrent high-grade glioma patients.
Gruber, Harry E, Hacke, Katrin, Hiraoka, Kei, Huang, Tiffany T, Inagaki, Akihito, Jolly, Douglas J, Kamijima, Shuichi, Kasahara, Noriyuki, Kato, Yuki, Kruse, Carol A, Matsumoto, Hiroshi, Mitchell, Leah A, Ostertag, Derek, Robbins, Joan M, Takahashi, Masamichi   +14 more
core   +1 more source

Brand and generic use of inhalation medication and frequency of switching in children and adults : a population-based cohort study [PDF]

, 2018
BACKGROUND: The expiration of patents of brand inhalation medications and the ongoing pressure on healthcare budgets resulted in a growing market for generics.
de Jongste, Johan C, Engelkes, Marjolein, Herings, Ron CM, Janssens, Hettie M, Kuiper, Josephine, Overbeek, Jetty A, Sturkenboom, Miriam CJM, van Blijderveen, Jan C, Verhamme, Katia   +8 more
core   +1 more source

Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review

The Journal of pharmacy and pharmacology, 2019
The objective of this review was to provide an overview of pharmacokinetic/pharmacodynamic (PK/PD) models, focusing on drug‐specific PK/PD models and highlighting their value added in drug development and regulatory decision‐making.
Ioannis Loisios-Konstantinidis, R. L. M. Paraiso, N. Fotaki, M. McAllister, Rodrigo Cristofoletti, J. Dressman   +5 more
semanticscholar   +1 more source

QUALITATIVE DRUG: WHAT SHOULD IT LOOK LIKE?

Рациональная фармакотерапия в кардиологии, 2016
Drug quality in modern market is discussed. There is an increase of a number of drugs that don’t meet to the quality requirements.Most of them are produced by Russian manufacturers, which number has also increased recently.
V. V. Iakusevich
doaj   +1 more source

Optimal testing of equivalence hypotheses

, 2005
In this paper we consider the construction of optimal tests of equivalence hypotheses. Specifically, assume X_1,..., X_n are i.i.d. with distribution P_{\theta}, with \theta \in R^k. Let g(\theta) be some real-valued parameter of interest.
Romano, Joseph P.
core   +2 more sources