ANEXA 3, RST

INDICATORI DE REALIZARE A PROIECTULUI

 

Denumirea indicatorilor

Numar

Planificat

Realizat

  • metode implementate:

 

 

 

o            Produse noi realizate in cadrul  programului, aliniate la standardele internationale: ALGOPIRIN (in conformitate cu normele internationale de buna practica de laborator si buna practica clinica)

0

1

  • agenti economici angrenati in parteneriate

3

3

  • valoarea dotarilor noi pe program

30% din buget

30%

  • brevete de inventie acceptate: Compoziţie medicamentoasă cu acţiune analgezică – antiinflamatoare şi descongestionantă, Brevet RO 120818 B1 /29.12.006 - ALGOPIRIN medicament produs LaborMed Pharma,

0

1

  • articole publicate

2006

1.       Dalia Miron, C. Mircioiu, V. Voicu, M. Ionescu,  I. Mircioiu, F. Radulescu: Formulation and evaluation of a preventive antidote in organophosphorous poisoning, Farmacia, vol. LIV, nr.2, 121-136, 2006.

2.       Josephina Neagu-Slobozeanu, Cristina Ghiciuc, C. Mircioiu, H. Seblani, Dalia Miron, G. Saramet: Validation of a HPLC method forthe determination of cephalexin in plasma designed to bioequivalence studies. I.Prevalidation, Farmacia, vol. LIV, nr.3, 73-81, 2006.

3.       Josephina Neagu-Slobozeanu, Cristina Ghiciuc, C. Mircioiu, H. Seblani, Dalia Miron, G. Saramet: Validation of a HPLC method forthe determination of cephalexin in plasma designed to bioequivalence studies. II.Methods for the evalluation of bioequivalence, Farmacia, vol. LIV, nr.4, 41-47, 2006.

4.       Cornelia Enăchescu, Some practical problems of compartmental modelling. Math. Reports, 8(58) (2006) pp. 137-150.

2007

5.        Ranetti Maria Cristina, Anuta Valentina, Miron Dalia Simona, Radulescu F., Mircioiu C., Mircioiu I.: Study Concerning Pharmacokinetic of Gliclazide after Oral Administration, Farmacia, vol. LV, nr.3, 257-266, 2007.

6.        V.A.Voicu, F. Radulescu, Dalia Miron, C. Mircioiu: CYP 2D6 polymorphism and interindividual variability of drug response. A risperidone study case, Revista de Medicina si Farmacie, Targu Mures, vol.53, supl.5, 265-270, 2007.

7.        Radulescu F., Miron Dalia Simona, Mircioiu C., Voicu V.: Distribution Profiles of Drugs with Active Metabolites by Compartmental Analysis, Farmacia, vol. LV, nr.4, 390-6,  2007.

8.        Radulescu F., Miron Dalia Simona, Voicu V., Mircioiu C.: Inter and Intravariability Cross-Analysis for CYP3A and 2D6 Substrates, Farmacia, vol. LV, nr.4, 2007.

9.        Cornelia Enãchescu, Denis Enãchescu, A multilayer perceptron network for the foetal weight prediction. Analele Univ. Buc., seria inf, XLV, (2006), pp. 73-84.

10.    Cornelia Enăchescu, A. Constantinescu, Using multilayer neural networks to estimate the parameters of the nonlinear Baret model. Biocybernetics and Biomedical Engineering, VOL 27, PART 3, (2007), pp. 95-111, Polish Scientific Publisher

11.    Cornelia Enăchescu, Some statistical techniques for outliers detection in bioequivalence studies. Proceedings of the 29th International Conference -MEDINF 2007, ISSN 1843-651X, "Lucian Blaga" University of Sibiu Editing House, (2007), pp. 264-276.

12.    Cornelia Enãchescu , Stéphane Milcent, Marianne Lorenzano, Denis Enãchescu, Philippe Birembaut, Frédéric Staerman, La ploide cellulaire:facteur prédictif de cancer de prostate localement avancé. Progrès en Urologie (ISSN 1761-676X); 2007, vol. 17, 4, pp. 819-824.

5

10

  • carti publicate

 

 

 

-  Carti tehnice: publicate in editura Universitara Carol Davila:

1. C. Mircioiu: Statistica aplicata in farmacie si studii clinice, Bucuresti, 2007

2. C. Mircioiu, D. Miron, F. Radulescu, C. Ghiciuc, I. Mircioiu: Elemente de biofarmacie si farmacocinetica, vol. I, FUNDAMENTE, Bucuresti, 2008

3. C. Mircioiu, D. Miron, F. Radulescu, C. Ghiciuc, I. Mircioiu: Elemente de biofarmacie si farmacocinetica, vol. II, EVALUARI COMPARATIVE SI CORELARI, Bucuresti, 2008

4. C. Mircioiu, R. Sandulovici: Aplicatii numerice de statistica in farmacie si in studiile clinice, vol. I, METODE MANUALE, Bucuresti, 2008

5. C. Mircioiu, R. Sandulovici: Aplicaţii Numerice de Statistică în Farmacie şi în Studii Clinice, vol. I, METODE COMPUTERIZATE, Bucuresti, 2008

6. C. Mircioiu, D.Enăchescu, C. Enăchescu, R.C. Sandulovici, Aplicaţii Numerice de Statistică în Farmacie şi în Studii Clinice, vol II, METODE COMPUTERIZATE, Editura Universitară Carol Davila, Bucureşti, 2008, ISBN 978-973-708-222-0

2

6

 

- Studii de fezabilitate: Laborator de testare medicamente in vitro si in vivo, martie 2008 (POSCCE-A2-O2.2.1-2007-1+Capacitati-I-2007-2)

 

 

- Metode:

1. ac. mefenamic, metode de dizolvare in :

- tampon fosfat pH=9.0

- tampon fosfat pH=6.8

- tampon fosfat pH=7.4

- tampon acetat pH=4.5

- solutie hcl 0.1N

- tampon acetat + 0.25% tween 80+0.25%trietanolamina pH=5.0

- tampon fosfat + 0.5% tween 80 pH=6.5

2. carbamazepina metode de dizolvare in :

·         dodecil sulfat de sodiu 1% ,

·         tampon fosfat pH 6.8

·         tampon fosfat pH 7.4

·         acetat de sodiu pH 4.5

·         HCl 0.1 N

3. metoprolol, metode de dizolvare in :

- mediu gastric simulat, fara enzime (pH=1,2)

- solutie tampon acetat pH=4,5

- solutie tampon fosfat pH=6,8

4.  ibuprofen metode de dizolvare in :

·         tampon fosfat pH=7.2

·         tampon fosfat ph=6.8

5.  nimesulid

6. Metode oficiale in USP pentru dizolvarea din forme  farmaceutice, aplicabile la testarea disponibilitatii farmaceutice:

·         Gliclazid

·         Acenocumarol

·         Aciclovir

·         Amoxicilina

·         Cefalexina

·         Doxiciclina

·         Glibenclamid

·         Izosorbid Mononitrat

·         Ketoconazol

·         Metotrexat

·         Tetraciclina

·         Paracetamol

 

 

·         comunicari stiintifice:

 

 

2006

  1. C Mircioiu:  Impact of Strategic Research Agenda  (SRA) “Innovative Medicines Initiative” (IMI) for Education and Training (E&T) Talin,  EAFP Conference ,  2006
  2. V. ANUTA, G. IONICA, E. GUTU, C. MIRCIOIU: POSTVALIDATION AND EVALUATION OF THE PERFORMANCES OF A CAPTOPRIL  BIOANALYTICAL METHOD IN A BIOEQUIVALENCE STUDY,  8-th International Symposium on Pharmaceutical Sciences, June 13 – 16, 2006, Ankara
  3. C. MIRCIOIU, D. , I. MIRCIOIU, F. RADULESCU:  Outliers And Pharmacokinetic Validation Of Data In Bioequivalence Studies,  8-th International Symposium on Pharmaceutical Sciences, June 13 – 16, 2006, Ankara
  4. F. Radulescu, D. , C. Mircioiu : Is More Sensitive To Formulation Changes Profile For Parent Drug Than That Of Metabolite ?, 13-th International Pharmaceutical  Symposium , 10 - 13 Sept. 2006, Antalya, Turkey

2007

  1. Radulescu, Mircioiu C.,  Dalia Simona, Ionica G., Velescu B.: Metrics of Sensitivity to Formulation Effects in Bioequivalence Studies for Drug with Active Metabolites, 3rd World Congress of the Board of Pharmaceutical Sciences of FIP (PSWC), 22-25 Aprilie 2007, Amsterdam, Olanda, poster KD-T-015
  2. Mircioiu C., Radulescu F.,  Dalia Simona, Sandulovici Roxana, Velescu B.: Degenerated Pharmacokinetic Models for Nicergoline Metabolites, 3rd World Congress of the Board of Pharmaceutical Sciences of FIP (PSWC), 22-25 Aprilie 2007, Amsterdam, Olanda, poster KD-T-010
  3. V Anuta, G Ionica, E Gutu, C Mircioiu  Postvalidation and evaluation of the performances of a captopril  bioanalytical method in a bioequivalence study , 3rd  Pharmaceutical Sciences World Congress, April 22-25, Amsterdam
  4. F.Radulescu, Voicu V.,  Dalia Simona, Mircioiu C.: Tmax Analysis as Supplementary Tool for in-vivo Formulation Performance, 13th Panhellenic Pharmaceutical Congress, 12-14 Mai 2007, Atena, Grecia, poster 238
  5.  F.Radulescu,  Dalia Simona, Voicu V., Mircioiu C.: Compartmental Analysis for Drugs with Active Metabolites, 13th Panhellenic Pharmaceutical Congress, 12-14 Mai 2007, Atena, Grecia, poster 239
  6.  D. , F. Radulescu, C. Mircioiu, V. Voicu Biopharmaceutical consideration on in vitro and in vivo partition coefficients, EUFEPS & COST B25 Conference on Bioavailability (BA) and Bioequivalence (BE):Focus on Physiological Factors and Variability, October 1-2, 2007, Athens, Greece
  7.  V.A.Voicu, M. Jiquidi, F. Radulescu, D. , C. Mircioiu:Pharmacokinetic profile scaling for risperidone in therapeutic monitoring, EUFEPS & COST B25 Conference on Bioavailability (BA) and Bioequivalence (BE):Focus on Physiological Factors and Variability, October 1-2, 2007, Athens, Greece
  8.  F. Radulescu, D. , C. Mircioiu, V. Voicu, V. Anuta, I. Mircioiu, C. Ranetti: Metformin dose-concentration profile as single active ingredient and in combination, EUFEPS & COST B25 Conference on Bioavailability (BA) and Bioequivalence (BE):Focus on Physiological Factors and Variability, October 1-2, 2007, Athens, Greece
  9.  C Mircioiu:  In vitro- in vivo correlations and non-correlations, 1st Central and Eastern European Forum on Bioequivalence Studies, Praga 1-2 noiembrie 2007
  10.  Cornelia Enăchescu, D.Enăchescu, Exploratory Data Analysis techniques for detection of possible outlying subjects in designs of bioavailability studies, Conference of Technologies of Knowledge Exploration and Representation, 5-9 Septembrie 2007, Holny Mejera, Polonia.

10

14

  • organisme ale infrastructurii de evaluare a conformitatii dezvoltate in cadrul programului:

 

 

 

-                  organisme de certificare: MEDFarmQuality CERT

0

1

propuneri de proiecte transmise la programe internationale: ITN MARIE CURIE, proiect IN SILICO, IN VITRO AND IN VIVO PHARMACO/ TOXICOKINETICS (“PHARM/TOX-KINETICS”) Call: FPT-PEOPLE-2007-1-1-ITN

 

 

Constructii institutionale si formare continua:

 

 

  • programe de masterat:

-         masterat biofarmacie si farmacocinetica UMF Bucuresti

-         masterat biostatistica Unversitatea Bucuresti

-         masterat biofarmacie si biostatistica UMF Craiova

0

3