[PDF][PDF] Clinical trials and clinical research: a comprehensive review

V Kandi, S Vadakedath - Cureus, 2023 - cureus.com
Clinical research is an alternative terminology used to describe medical research. Clinical
research involves people, and it is generally carried out to evaluate the efficacy of a …

Biowaiver monograph for immediate-release solid oral dosage forms: amoxicillin trihydrate

D Thambavita, P Galappatthy, U Mannapperuma… - Journal of …, 2017 - Elsevier
Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for
the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate …

Targeted adsorption of molecules in the colon with the novel adsorbent‐based Medicinal Product, DAV132: A proof of concept study in healthy subjects

J de Gunzburg, A Ducher, C Modess… - The Journal of …, 2015 - Wiley Online Library
During antibiotic treatments, active residuals reaching the colon profoundly affect the
bacterial flora resulting in the emergence of resistance. To prevent these effects, we …

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers

C Blandizzi, GC Viscomi, A Marzo… - Pharmacological …, 2014 - Elsevier
Rifaximin is an antibiotic, locally acting in the gastrointestinal tract, which may exist in
different crystal as well as amorphous forms. The branded rifaximin formulation contains the …

“Ten commandments” for the appropriate use of antibiotics by the practicing physician in an outpatient setting

G Levy-Hara, CF Amábile-Cuevas, I Gould… - Frontiers in …, 2011 - frontiersin.org
A multi-national working group on antibiotic stewardship, from the International Society of
Chemotherapy, put together ten recommendations to physicians prescribing antibiotics to …

Healthy volunteers and early phases of clinical experimentation

G Pasqualetti, G Gori, C Blandizzi… - European journal of …, 2010 - Springer
The main goal of early phase trials is to gain knowledge about the clinical suitability of novel
compounds, without pursuing specific therapeutic purposes. Healthy volunteers usually …

[HTML][HTML] The impact of the Sri Lankan economic crisis on medication adherence: An online cross-sectional survey

R Jayawardena, W Kodithuwakku, P Sooriyaarachchi - Dialogues in Health, 2023 - Elsevier
Background The economic crisis in Sri Lanka has disarrayed the country's healthcare
services, posing a challenge to people with chronic diseases on routine care. This study …

Efficacy and quality of antibacterial generic products approved for human use: a systematic review

P Tattevin, AC Crémieux, C Rabaud… - Clinical infectious …, 2014 - academic.oup.com
Background. Concerns have recently emerged about the efficacy and the quality of
antibacterial generic products approved for use in humans. Methods. We searched Medline …

Generic antibiotic drugs: is effectiveness guaranteed?

R Gauzit, M Lakdhari - Medecine et maladies infectieuses, 2012 - Elsevier
There are recently published arguments suggesting all generic antibiotic drugs do not
present the full reliability needed to claim therapeutic equivalence with branded drugs. The …

Comparison of generic‐to‐brand switchback rates between generic and authorized generic drugs

RA Hansen, J Qian, R Berg, J Linneman… - … : The Journal of …, 2017 - Wiley Online Library
Study Objective Generic drugs contain identical active ingredients as their corresponding
brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized …