<p>Biovitrumis is one of the larger biopharma companies in Euprope and conducts research in different niche areas. One of the interested areas for Biovitrum is Exocrine Pancreatic insufficiency. Biovitrum has a candidate drug (product D) in early development process for treatment of. Exocrine Pancreatic Insufficiency.</p><p>The Drug development is a long, complicated and costly process. Therefore, it is very important for managers to know the commercial value of a future drug. The purpose of this report is to develop a model for evaluation of candidate drug in early development phase and analysis of market potential for product D for treatment of Chronic pancreatitis. Chronic pancreatitis is disease within sub group of Exocrine Pancreatic Insufficiency.</p><p>The deductive reasoning approach and quantitative data is used in this report. Only secondary data is collected for this study. The sources of secondary data are research papers, Google Pub-Med database and consultant companies.</p><p>A new model is developed for evaluation of candidate drug .This model can analyse the market potential, unmet medical need, and calculate net present values. This study shows that there is unmet medical need in chronic pancreatitis. The result also shows that product D has comparative advantages over present products in the market and future competitors. The product D can full fill the unmet medical need for treatment of Chronic pancreatitis</p>

Biovitrumis is one of the larger biopharma companies in Euprope and conducts research in different niche areas. One of the interested areas for Biovitrum is Exocrine Pancreatic insufficiency. Biovitrum has a candidate drug (product D) in early development process for treatment of. Exocrine Pancreatic Insufficiency. The Drug development is a long, complicated and costly process. Therefore, it is very important for managers to know the commercial value of a future drug. The purpose of this report is to develop a model for evaluation of candidate drug in early development phase and analysis of market potential for product D for treatment of Chronic pancreatitis. Chronic pancreatitis is disease within sub group of Exocrine Pancreatic Insufficiency. The deductive reasoning approach and quantitative data is used in this report. Only secondary data is collected for this study. The sources of secondary data are research papers, Google Pub-Med database and consultant companies. A new model is developed for evaluation of candidate drug .This model can analyse the market potential, unmet medical need, and calculate net present values. This study shows that there is unmet medical need in chronic pancreatitis. The result also shows that product D has comparative advantages over present products in the market and future competitors. The product D can full fill the unmet medical need for treatment of Chronic pancreatitis

Submitted by Marcos Anselmo (marcos.anselmo@unipampa.edu.br) on 2016-09-22T13:21:31Z No. of bitstreams: 2 license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) BARBRA KATYÚSCYA SANCHES MORAES.pdf: 1057225 bytes, checksum: 43106c269cbed3f116c11fc89abec2f5 (MD5) / Approved for entry into archive by Marcos Anselmo (marcos.anselmo@unipampa.edu.br) on 2016-09-22T13:22:21Z (GMT) No. of bitstreams: 2 license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) BARBRA KATYÚSCYA SANCHES MORAES.pdf: 1057225 bytes, checksum: 43106c269cbed3f116c11fc89abec2f5 (MD5) / Made available in DSpace on 2016-09-22T13:22:21Z (GMT). No. of bitstreams: 2 license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) BARBRA KATYÚSCYA SANCHES MORAES.pdf: 1057225 bytes, checksum: 43106c269cbed3f116c11fc89abec2f5 (MD5) Previous issue date: 2015-05-29 / Neste estudo, um método de CLAE-DAD foi desenvolvido e validado para a determinação de LASSBio-1736 em plasma de rato usando diclofenaco de sódio como padrão interno (PI). Extração líquido-líquido com acetonitrila foi utilizado para extrair LASSBio-1736. A separação cromatográfica foi realizada com coluna Waters Spherisorb®S5 ODS2 C18 (150 mm x 4,6 mm, 5μm), fase móvel isocrática composta por Trietilamina 0,3% (pH 4), metanol e acetonitrila (45:15:40, v/v/v) com vazão de 1 mL/min. Ambos LASSBio-1736 e PI foram eluídos em 4,2 e 5 min, respectivamente. O limite inferior de quantificação foi de 0,2 μg/mL e linearidade entre 0,2 - 4 μg/mL, com um r2> 0,99. A exatidão do método foi > 90,5%. Os desvios padrão relativos intra e inter-dias foram < 6,19 e < 7,83%, respectivamente. O método mostrou sensibilidade, linearidade, precisão, exatidão e seletividade necessária para quantificar LASSBio-1736 em estudos farmacocinéticos pré-clínicos O presente trabalho também investigou a farmacocinética plasmática e a distribuição do LASSBio-1736 em ratos Wistar. A farmacocinética de LASSBio-1736 foi investigada após a administração de dose intravenosa (3,2 mg/kg), por via oral e intraperitoneal (12,6 mg/kg).. A distribuição nos tecidos foi avaliada após administração de dose i.v. bolus. Os resultados para a via intravenosa indicam longo tempo meia-vida (24,3 ± 8,2 h), depuração de 49,3 ± 9,8 mL/Kg*h e volume de distribuição de 1,16 ± 0,3 L/kg. Para a via oral o tempo meia-vida foi de 28,6 ± 4,6 h, depuração de 49,7 ± 13 mL/Kg*h e volume de distribuição de 1,47 ± 0,34 L/kgforam semelhantes e biodisponibilidade de 12%. Para a via intraperitoneal o tempo meia-vida foi de 26 ± 8,9 h, depuração de 58 ± 19,6 mL/Kg*h e volume de distribuição de 1,8 ± 0,8 L/kg e biodisponibilidade de 38%. O LASSBio-1736 demonstrou penetração tecidual adequada no fígado, baço e pele. Com base nas características farmacocinéticas de outros fármacos leishmanicidas e a proposição de decisão para estudos farmacocinéticos visando a descoberta de candidatos a fármacos e a continuidade dos estudos, o LASSBio-1736 possui características farmacocinéticas apropriadas para um medicamento leishmanicida e novos estudos devem ser realizados para o escalonamento interespécies, além de estudos farmacológicos e toxicológicos complementares. / In this study, a method was developed and validated for HPLC-PDA determination LASSBio-1736 in rat plasma using diclofenac sodium as internal standard (IS). Liquid-liquid extraction was used to extract acetonitrile LASSBio-1736. The chromatographic separation was performed with Waters Spherisorb®S5 ODS2 C18 column (150 mm x 4.6 mm, 5μm), isocratic mobile phase consisting of Triethylamine 0.3% (pH 4), methanol and acetonitrile (45:15:40, v / v / v) with a flow rate of 1 mL/min. Both LASSBio-1736 and IS were eluted at 4.2 and 5 min, respectively. The lower limit of quantification was 0.2 μg/mL and linearity between 0.2 - 4 μg/mL, with r2> 0.99. The accuracy was > 90.5%. The relative standard deviation within and between days were < 6.19 and < 7.83%, respectively. The method showed sensitivity, linearity, precision, accuracy and selectivity needed to quantify LASSBio-1736 in preclinical pharmacokinetic studies. This study also investigated the plasma pharmacokinetics and distribution of LASSBio-1736 in Wistar rats. The pharmacokinetic LASSBio-1736 was investigated after intravenous dose administration (3.2 mg/kg) intraperitoneally and orally (12.6 mg/kg). The tissue distribution was evaluated after iv bolus dose administration. The results indicated an intravenous long half-life (24.3 ± 8.2 h) clearance 49.3 ± 9.8 mL/kg*h and the volume of distribution 1.16 ± 0.3 L/ kg. The oral route the half-life was 28.6 ± 4.6 h, clearance 49.7 ± 13 mL/kg*h and volume of distribution 1.47 ± 0.34 L/kg and bioavailability of 12%. The intraperitoneally half-life was 26 ± 8.9 h, clearance 58 ± 19.6 mL/kg*h and the volume of distribution 1.8 ± 0.8 L/kg and bioavailability of 38%were similar. The LASSBio-1736 showed adequate tissue penetration for liver, spleen and skin. Based on the pharmacokinetic characteristics of other antileishmanial drugs and the decision proposition for pharmacokinetic studies for the discovery of drug candidates and continuing studies, the LASSBio-1736 has pharmacokinetic characteristics appropriate for a leishmanicide and new drug studies should be conducted to the interspecies scaling, and additional pharmacological and toxicological studies.