Publicaciones Científicas
Los artículos de investigacion constituyen el medio que valida nuestras actividades científicas a traves de su publicacion en diferentes journals nacionales y/o internacionales con referato. Las actividades de prensa permiten comunicar nuestra experiencia en proyectos de investigación y conjuntamente con la publicidad en distintos medios gráficos nuestra trayectoria.
Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in helthy adults
28 de Julio de 2023
A Gamma Variant RDB-based aluminium hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18 - 55 years old) with a complete COVID-19 primary vacine scheme were assigned to receive two intramuscular doses of either a lowdose or high-dose of ARVAC CG.
Pharmacokinetics of a new fixed-dose combination of candesartan cilexetil, hydrochlorothiazide, and rosuvastatin in healthy adult subjects
18 de Mayo de 2021
Cardiovascular disease is the primary cause of death globally based on data from the World Health Organization, with an estimated 18 million deaths each year, constituting 31% of all deaths [1]. Moreover, in spite of current recommendations and availability of effective medication, more than 23 million people are predicted to die annually from cardiovascular diseases by 2030 [2]. Dyslipidemia and hypertension are well recognized risk factors for heart disease and stroke [3].
Clinical investigation of the biopharmaceutical characteristics of nifurtimox tablets – Implications for quality control and application
12 de Julio de 2021
Nifurtimox is approved in Chagas disease and has been used in endemic countries since the 1960s. Nifurtimox, available as a 120 mg tablet, is administered with food typically three times daily, and dose is adjusted for age and bodyweight. Accurately or reproducibly fragmenting the 120 mg tablet for dose adjustment in young children and those with low bodyweight is problematic.
Registro Auditoria FV-RE-10 VD01 FP Clinical Pharma (Argentina)
27 de Abril de 2021
Durante la auditoría se revisó con detalle el proceso de recogida, evaluación, interpretación, codificación y reporte de reacciones adversas, que es la actividad para la que Spedrog Caillón tiene subcontratados los servicios de FP Clinical Pharma. Este proceso se había descrito previamente en el cuestionario de auditoría que había sido recibido en fecha 31/03/2021.
Biopharmaceutical Characteristics of Nifurtimox Tablets for Age and Body Weight-Adjusted Dosing in Patients With Chagas Disease
2 de Septiembre de 2020
Treatment of Chagas disease with nifurtimox requires age- and body weight-adjusted dosing, resulting in complex dosing instructions. Appropriate formulations are needed for precise and compliant dosing, especially in pediatric patients. We characterized the biopharmaceutical features of a standard nifurtimox 120-mg tablet and a 30-mg tablet developed to improve dose accuracy. Two open-label, randomized crossover studies were conducted in adult outpatients with Chagas disease.
Comparative Bioavailability of a New Fixed Dose Combination Tablet Containing Lumacaftor/ Ivacaftor in Healthy Subjects: A Randomized, Single-Dose, 2-Way Crossover Study
13 de Septiembre de 2019
Lumacaftor (LUM) has been clinically developed in combination with ivacaftor (IVA) as a fixed-dose combination (FDC) tablet for oral administration for the treatment of Cystic fibrosis (CF), a chronically autosomal recessive genetic disease affecting more than 70,000 people worldwide with a median age of death of approximately 30.6 years in the United States [1,2]. CF is caused by a mutation in the gene that encodes for the CF transmembrane conductance regulator (CFTR) protein [3]. The CFTR protein is an epithelial chloride channel located in multiple organs, being responsible for maintaining the regulation of salt and water absorption and secretion [4].
Comparative Bioavailability of Two Oral Perampanel Formulations in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study
05 de Septiembre de 2017
Perampanel (CAS 380917-97-5) is an Antiepileptic Drug (AED) with novel mechanism of action due to its selective, non-competitive AMPA glutamate receptor antagonist [1]. A subtype glutamate receptor, AMPA (a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) has been an active target for epilepsy drug development because it seems to participate in the induction and spread of epileptic seizures [2]. Phase III clinical trials have established the efficacy and safety of perampanel as adjunctive therapy for partial seizures with or without secondary generalized seizures in patients with epilepsy aged =12 years old [3 - 5]. Perampanel oral film-coated tablet formulations were developed to enhance patient adherence to treatment. A hallmark of perampanel is its long half-life allowing just a one daily dose which contribute to the patient drug compliance [6].
Effect of a high-calorie, high-fat meal on the pharmacokinetics of oral nifurtimox in adults with chronic Chagas’ disease
2016
Nifurtimox (NFX) is one of only two treatments for patients with Chagas’ Disease (CD); a 30 mg tablet suitable for age-appropriate dosing of pediatric CD patients has been developed recently. As NFX is a poorly soluble and highly permeable drug, food can have a considerable effect on its uptake from the GI tract. We therefore conducted a Phase I study to investigate this possible food effect, initially in adults.
Plasma Enalapril Kinetics of Two Modified Formulations Tested in Healthy Volunteers. A Pilot Trial Searching for an Optimum Blood Pressure Control.
Julio 2016
However, few data exist on central systolic and diastolic pressures (SBPC, DBPC) and arterial stiffness in these patients, and the effect of treatment on them.In this study we present the findings of a group of patients (P) receiving treatment established by their general pressure and pulse wave velocity (PWV) between men and women with IH with treatment prescribed by their general practitioner.
Pharmacokinetic Drug-drug Interaction Study of Benznidazole and E1224 in Healthy Male Volunteers
Septiembre 2015
Chagas disease (CD) is an important global neglected tropical disease, where new, better tolerated, therapeutic options are needed. Benznidazole (BNZ) is the drug of choice for treating adults and children with CD. E1224 (ravuconazole ([RVZ]) prodrug) is an antifungal drug with promising anti-T. cruzi activity, but unsatisfactory clinical results in monotherapy. Combination treatment is a well-recognised treatment modality, with potential in CD to improve efficacy and safety and reduce putative risk of resistance. Little is known about the metabolism and absorption of BNZ, therefore its interaction with other drugs cannot be easily anticipated. An in vivo interaction study in healthy volunteers was designed to assess the pharmacokinetics (PK) and safety interaction of BNZ and E1224.
Single-Dose Bioequivalence of a New Fixed-Dose Combination Tablet Containing Tenofovir Disoproxil Fumarate and Lamivudine
2011
Tenofovir disoproxil himarate (TDF) is a nucleotide analog reverse transcriptase inhibitor orally bioavailable as an ester-derived prodnig which requires &ester hydrolysis for conversion to tenofovir (TFV) and subsequent intracellular phosphorylations by cellular enzymes to the active metabolite, tenofovir diphosphate, which is a competitive inhibitor of HIV-1 reverse transcriptase, leading to the prevention of DNA chain elongation and termination of viral DNA growth [1,2].
Bloequivalence study of two oral tablet formulations containing saquinavir mesylate boosted with ritonavir in healthy male subjects
2011
Saquinavir (SAQ) is a potent inhibitor of the 1-11V-1 pro-tease and It is a well established component of current highly active antiretrovirel therapy (HAART) regimen's [1-6]. SAQ is a peptide-like substrate analogue that binds to the HIV protease active site and inhibits its ac-tivity which prevents cleavage of the viral polyproteins resulting in the formation of immature noninfectious virus particles, SAQ mesylate (CAS 149845-06-7) 500 mg film coated tablet (FCT) formulation was firstly devel-oped to support patient adherence to treatment by re-ducing daily pill burden and was approved by the Food and Drug Administration (FDA), USA in 2005 after de-monstrating bioequivalence to SAQ 200 mg hard cap-sules [1].
Bioequivalence study of two oral tablet formulations containing tenofovir disoproxil fumarate in healthy volunteers
2011
Tenofovir disoproxil fumarate (TDF, CAS 147127-20.6) is an orally bioavailable ester-derived prodrug which is converted in vivo by serum and tissue esterases to teno-fovir (TFV), an acyclic nucleotide. Intracellular phos-phorylation of TFV yields the active metabolite, tenofo-vir diphosphate, which is a competitive inhibitor of 141V-1 reverse transcriptase, leading to the prevention of DNA chain elongation and termination of viral DNA growth 11-31. TFV was approved by the Food and Drug Administration (FDA) in October 2001 and is indicated for use in combination with other antiretroviral agents for the management of HIV-1 infection [4 - 6].
Healthy volunteers for bioequivalence trials: predictive factors for enrollment failures - a case - control study
Marzo 2011
A determinant factor for the success of a clinical trial is the adequate selection of the study population which allows the recruit-ment and enrollment of subjects who fulfill protocol criteria [1]. A subject is considered to be recruited when he/she signs the in-formed Consent Form document; then a sub-ject is considered enrolled if he/she fulfills the eligibility criteria and is effectively included in the study.
Principios Básicos en la Investigación de productos Farmacéuticos
2003
El descubrimiento de una nueva molecule comienza en el contexto de la ciencia basica denim del ambito de un laboratorio, donde se produce la sintesis de una nueva droga junto con el ballazgo de una respuesta biologic-a In Vitro que anticipa un potencial efecto terapeutico. Una extensa bateria de ensayos denominados pre-clinicos —ensayos In Vitro en tejidos, modelos animates, ensayos ffsico-quimicos y de manufacture— preceden a la pri-mers administraciem de esa nueva molecule en un reducido nfunero de se-res humanos (ensayos de Fase I). El propesito de los ensayos preclinicos es el de obtener datos que apoyen, con cierto grado de seguridad la decisi6n del use del farmaco en seres humanos.
Estudio de Bioequivalencia en Dosis Única de Micofenolato Mofetilo 500 en Sujetos Voluntarios Sanos
29 de Octubre de 2009
El micofenolato de mofetilo (MMF) es un profármaco del ácido micofenólico (MPA), utilizado en la terapéutica inmunosupresora para inhibir el rechazo de trasplantes de órganos sólidos. El MPA presenta una baja y errática absorción oral. Su pro droga, el MMF (2-morfolino-etil-ester), se desarrolló para incrementar su biodisponibilidad, debido a que es bien absorbida desde el tracto gastrointestinal y rápidamente hidrolizada para convertirse en el principio activo, el MPA. Laboratorios Sandoz S.A. desarrolló una formulación oral sólida conteniendo 500 mg. de micofenolato de mofetilo (producto test) equivalente farmacéutico al Cellcept® de Productos Roche (producto referencia). La evaluación de Bioequivalencia de los medicamentos inmunosupresores es un requisito regulatorio en Argentina debido a que se trata de fármacos con alta variabilidad en las concentraciones séricas y que requieren monitoreo terapéutico.
Relative Bioavailability of Two Drug Products of Somatropin Obtained from Either the Milk of Transgenic Cows or Bacterial Culture
9 de Marzo de 2010
Growth hormone (GE) therapy with exogenous human growth hormone (hGH) has been used for many decades to treat children with GH deficiency (GHD) [I, 21. to the early times, the supply could not meet the demand to all patients with GHD. Since 1985, hGH produced uswg recombinant DNA technology has been approved and has been assigned the international non-proprietary name somatropin, with the Anatomical Therapeutic Chemical M.E.C. and R,A.D. are staff of Bra Sidurx S.A.; J, F. and I.B. are paid advi-sors to Bic Sidius 5.A.; FP Clinical and CDM were contracted for the execution of this study.
Journal Pre-proof
26 de Junio de 2021
Clinical investigation of the biopharmaceutical characteristics of nifurtimox tablets – implications for quality control and application Heino Stass, Sarah Just, Boris Weimann, Ibrahim Ince, Stefan Willmann, Ethel Feleder, Cecilia Freitas, Gustavo Yerino, Uwe M¨unster. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Estudio De Bioequivalencia En Voluntarios Sanos De Zidovudina, Abacavir Y Lamivudina En Dosis Única De Dos Formulaciones Diferentes: Trivudin® Y Tricivir®
29 de Octubre de 2009
La terapia combinada con drogas antirretrovirales para el tratamiento del VIH en adultos constituye actualmente el tratamiento de primera elección. La combinación de tres nucleósidos análogos inhibidores de la transcritas a reversa (NRTIs), es recomendada como una de las primeras líneas de tratamiento. En tal sentido, el desarrollo de formulaciones orales conteniendo una triple combinación a dosis fija resulta fundamental para favorecer la adherencia de los pacientes al tratamiento. Laboratorios Richmond ha desarrollado una formulación sólida oral Trivudin® que contiene una combinación a dosis fija de tres NRTIs: Abacavir 300 mg, Lamivudina 150 mg. y Zidovudina 300 mg. equivalente farmacéutico al producto al Tricivir® de GlaxoSmithKline S.A.