Results 31 to 40 of about 28,368 (156)

A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure

BMC Nephrology, 2021
Background Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage.
Soo Kun Lim, Bak Leong Goh, Ravindran Visvanathan, Su Hyun Kim, Jin Seok Jeon, Sung Gyun Kim, Jae Hyun Chang, Chun Soo Lim, Zaki Morad   +8 more
doaj   +1 more source

Bioequivalence of a New Pediatric Paracetamol Oral Suspension Compared With a Marketed Formulation in Healthy Adults: A Randomized, Open-Label Study

Current Therapeutic Research
: Background: A new oral paracetamol formulation with the same paracetamol quantity (24 mg/mL) as a marketed formulation but with finer active ingredient particle size and lower amounts of maltitol (5.85 g/dose in the test formulation vs 7.25 g/dose in ...
Jiri Grim, MD, PhD, Marianna Armogida, MD, Preeti Kachroo, BAMS, MD(AM), Kamran Siddiqui, MBBS, MBA, Mauro Cavinato, PhD, Mako Araga, MS   +5 more
doaj   +1 more source

In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin

BMC Infectious Diseases, 2010
Background Oxacillin continues to be an important agent in the treatment of staphylococcal infections; many generic products are available and the only requirement for their approval is demonstration of pharmaceutical equivalence.
Agudelo Maria, Rodriguez Carlos A, Zuluaga Andres F, Vesga Omar   +3 more
doaj   +1 more source

Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients

Archives of Pharmaceutical Sciences Ain Shams University, 2020
Economic benefits associated with usage of generic drugs have been suggested to increase patients’ adherence to their medications and to improve patients’ health outcomes.
Hadeer Eid, Hazem Khorshid, Ahmed Elsherif, Ebtissam Darweesh, Nagwa Ali Sabri, Naglaa Bazan   +5 more
doaj  

Generic therapy: the problem of choice

Кардиоваскулярная терапия и профилактика, 2009
The main differences between original and generic medications are discussed, and the criteria necessary for official generic registration are presented.
S. N. Tolpygina
doaj  

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

Frontiers in Medicine
Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine.
Kevin Klein, Jens Heisterberg, Pieter Stolk   +2 more
doaj   +1 more source

Development of Drug-Device Combination Products and Generic Substitution in the United States

INNOVATIONS in Pharmacy
Generic drug products approved and marketed in the United States include a variety of drug classes and dosage forms along with drug-device combination products (DDCPs).
YoonJung Lee, Ila Srivastava, Katharine B. Feibus, Elizabeth R. Bielski, Lolita Sterrett, Danielle Harris, Markham C. Luke   +6 more
doaj   +1 more source

Therapeutic equivalence of inhaled salbutamol [PDF]

Thorax, 2000
The meta-analysis by Hughes et al was hindered by difficulties in comparing trials that were often flawed and of varied design.1 The authors correctly pointed out that, in most of the studies, the use of equivalence as the null hypothesis was invalid. In addition, all but two of the studies looked at the bronchodilator effects in the presence of basal ...
openaire   +1 more source

Drug interchangeability: Clinical efficacy and safety

Неврология, нейропсихиатрия, психосоматика, 2017
The paper deals with the problem of the interchangeability of brand-name and generic drugs. Touching upon official terminology and the normative documents that govern the registration of generics in Russia and foreign countries, the authors state that ...
S. K. Zyryanov, S. B. Fitilev, I. I. Shkrebneva, A. V. Vozzhaev   +3 more
doaj   +1 more source

Modern approaches to the assessment of orally inhaled products bioequivalence

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article analyses regulatory documents containing requirements for clinical (trials) documentation for orally inhaled products, including requirements for the demonstration of therapeutic equivalence of medicinal products for the treatment of ...
E. S. Petrova, D. V. Goryachev, M. V. Petrov   +2 more
doaj