Balance Mechanism Study between Brand-Name Drugs and Generic Drugs in American Drug Review / 中国药学杂志

OBJECTIVE: To figure out the balance mechanism between brand-name drugs and generic drugs in American drug review. METHODS: This paper reviewed FDA laws and regulations, domestic and foreign literature to retrospect the basis of generic development and explore the brand-name drug companies' action to prevent generic competition. RESULTS AND CONCLUSION: The abbreviate new drug application, patent challenge and market exclusivity in the Hatch-Waxman Act were the basis of generic development. Brand-name drug companies prevented competition by occupying the market, refusing to provide samples, submitting citizen petitions to extend generic drug review time and extending the patent term and market exclusivity of brand-name drugs. The United States legislated and amended relevant laws and regulations, adjusted the generic drug user fee to maintain the stability of the balance, which is worthy of further research.

Lectin, hemolysin and protease inhibitors in seed fractions with ovicidal activity against Haemonchus contortus / Lectina, hemolisina e inibidores de protease em frações de sementes com atividade ovicida contra Haemonchus contortus

Bioactive molecules of plant species are promising alternatives for the chemical control of gastrointestinal nematodes in ruminants. Extracts of native and exotic seed species from Brazil's semi-arid region were tested in vitro in an egg hatch assay and the bioactivity of their proteins was investigated. Each seed species was subjected to three extractions with three types of solvents. All the seeds showed ovicidal activity, which varied according to the solvents. Higher ovicidal activity was found in the molecule fractions of low molecular weight (<12 kDa) for Albizia lebbeck, Ipomoea asarifolia, Jatropha curcas, Libidibia ferrea, Moringa oleifera and Ricinus communis (P<0.05, Bonferroni test). The two fractions of Crotalaria spectabilis showed the same ovicidal activity (P>0.05, Bonferroni test). Hemagglutinating activity was detected in the fractions of C. spectabilis and M. oleifera fractions, hemolysin activity in the A. lebbeck and M. oleifera fractions, serine protease inhibitory activity in the A. lebbeck, I. asarifolia, J. curcas, M. oleifera and R. communis fractions, cysteine protease inhibitor activity in the M. oleifera fraction, and no protein activity in the L. ferrea fraction. The results of this work reveal new plant species with a potential for use in controlling nematode parasites in goats, thus opening a new field of research involving plant protein molecules with ovicidal properties.

Moléculas bioativas de espécies vegetais são alternativas promissoras ao controle químico dos nematoides gastrintestinais em ruminantes. Extratos de sementes de espécies nativas e exóticas do Semiárido Brasileiro foram testados in vitro em ensaio de eclosão de ovos e investigada a natureza proteica da bioatividade. Três extrações com três solventes foram feitas para cada semente estudada. Todas as sementes apresentaram atividade ovicida, variando com o solvente utilizado. Maior taxa de inibição da eclosão concentrou-se nas frações de moléculas de baixa massa molecular (<12 kDa) para Albizia lebbeck, Ipomoea asarifolia, Jatropha curcas, Libidibia ferrea, Moringa oleifera e Ricinus communis (P<0,05, teste de Bonferroni). Crotalaria spectabilis mostrou atividade nas duas frações, sem diferença entre elas (P>0,05, teste de Bonferroni). Observou-se atividade hemaglutinante nas frações de C. spectabilis e M. oleifera, de hemolisina em A. lebbeck e M. oleifera, de atividade inibidora de protease da serina em A. lebbeck, I. asarifolia, J. curcas, M. oleifera e R. communis, de atividade inibidora de protease da cisteína em M. oleifera e nenhuma atividade proteica na fração de L. ferrea. Os resultados revelaram novas espécies botânicas com potencial de controle de nematoides em caprinos e um novo campo de pesquisa, o estudo de moléculas de origem proteica com atividade ovicida.

THE COMPARATIVE EVALUATION USING HATCH REAMER TECHNIQUE AND OSTEOTOME TECHNIQUE IN SINUS FLOOR ELEVATION

0.05). 2. At the total success rate, osteotome group was 92.4% and Hatch reamer group was 94.9%. There was no statistically significant difference between the two groups (P > 0.05). 3. On the discomfort during the operation by using numerical rating scale, osteotome group was 2.87 +/- 0.83 and Hatch reamer group was 1.12 +/- 0.64. There was statistically significant difference between the two groups (P < 0.05). The Hatch reamer group' clinical results was similar to osteotome group and we thought that Hatch reamer technique can overcome the faults of osteotome technique.

Desenvolvimento folicular de embriões de frangos de corte de diferentes genótipos expostos ao estresse térmico crônico / Folicular development of chicken broiler embryos of different genotypes, exposed to chronic thermal stress

O objetivo do trabalho foi avaliar as alterações tegumentares (morfogênese da pena), em embriões de frangos de corte de linhagens de diferentes padrões de crescimento, obtidos de ovos incubados sob diferentes temperaturas. Os ovos foram obtidos de matrizes das linhagens Cobb 500 e ISA JA57, distribuídos proporcionalmente em três incubadoras. Do primeiro (D1) ao sexto dia (D6) de incubação, utilizou-se uma temperatura padrão (37,8°C). A partir do sétimo dia (D7) e até o momento do nascimento aos 21 dias (D21), uma das incubadoras teve a temperatura reduzida para 36,8°C (fria) e uma outra alterada para 38,8°C (quente). A terceira incubadora foi mantida a 37,8°C (controle). O delineamento adotado foi o inteiramente casualizado, em esquema fatorial 3 x 2 (temperatura de incubação e linhagem). A temperatura de incubação e a linhagem não alteraram a densidade dos folículos da pena (número médio de folículos por área de 337,5µm²) nas regiões femural e dorsopélvica dos embriões até os 11 dias (D11). Entretanto, observou-se aumento na densidade folicular na região dorsal dos embriões aos 16 dias (D16) devido ao aumento da temperatura, permanecendo até o momento do nascimento. É possível oncluirque embriões incubados em temperatura acima da recomendada (38,8°C) apresentam uma maior densidade de folículos na região dorsopélvica. Apesar disso, a morfogênese dos folículos permaneceu inalterada.

The objective of this research was to evaluate the tegument modification (feather morphogenesis) in embryos of broiler chicken, of different growth standard breeder lines, obtained from eggs incubated under different temperatures. Eggs of Cobb 500 and ISA JA57 breeders lines, were proportionally distributed in three incubators. From the first (D1) to the sixth day (D6) of incubation, temperature was maintained standard at 37.8°C. From the seventh day (D7) until the moment of the birth on the twenty one days (D21), temperature was reduced to 36.8°C (Cold) in one of the incubators, and in another incubator was increased to 38.8°C (Hot). The temperature in the third incubator was maintained at 37.8°C (Control). It was used a completely randomized design with factorial 3 x 2 (temperature of incubation and breeder lines). Incubation temperature and breeder factor do not modify the follicular density of the feather (average number of follicles per area of 337.5µm²) in the femoral and dorsal tract of until eleven days (D11) embryos. An increase of follicular density in the dorsal region of sixteen days (D16) embryos was observed, because the temperature increased, of the remaining until the moment of birth, demonstrating that embryos incubated above the recommended temperature (38.8°C) present higher follicles density in the dorsal tract. However, follicles morphogenesis remained unaltered.

Desarrollo embrionario-larval del pez tropical Hemirhamphus brasiliensis (Beloniformes: Hemirhamphidae) a partir de huevos recolectados del medio natural

Embrionary-larval development of the tropical fish Hemirhamphus brasiliensis (Beloniformes: Hemirhamphidae) from eggs collected in the wild. The embryo formation and larval development of Hemirhamphus brasiliensis Linnaeus, 1758 (Pisces: Hemirhamphidae) is described from morula stage eggs collected on Sargassum sp. Thalii in the field (10°50’55.2" N y 64°09’467" W). The eggs were spherical, 1 923.54 ±72.35 µm diameter with several corionic filaments, and are striated. During the first 48 h the embryo developed cephalic vesicle, miomers, and a heart located on the external body surface, beating strongly and circulating colorless blood which became pigmented red later. Before hatching, the larva developed kidney, gut tract, liver and biliar vesicle, pectoral fins, four pairs of gill arches and the mouth. The larva hatched at 114 h, the body was torpedo-shaped, yellow-green, with several dendriform melanophores; the pelvic fin was observed 72 h post hatching. At 240 hours the metamorphoses was completed. When the larvae hatched they could ingest Artemia metanauplii. Rev. Biol. Trop. 56 (3): 1449-1458. Epub 2008 September 30.

Se describe la formación del embrión y el desarrollo larval del pez Hemirhamphus brasiliensis Linnaeus, 1758, a partir de huevos en estado de mórula, recolectados en el alga parda Sargassum sp. Los huevos eran esféricos con un diámetro de 1923.54 ±72.35 µm, con numerosos filamentos coriónicos y estrías en su superficie. Durante las primeras 48 h, el embrión desarrolló la vesícula cefálica, los miomeros y el corazón, el cual se ubicó en el exterior de cuerpo impulsando sangre incolora, la cual se pigmentó de rojo posteriormente. Antes de la eclosión se desarrollaron el riñón, estómago, hígado y la vesícula biliar, las aletas pectorales, cuatro pares de arcos branquiales y la boca. Las larvas eclosionaron a la 114 h, presentando el cuerpo robusto en forma de torpedo, verde-amarillo con melanoforos dendriformes. Al nacer ingirieron metanauplios de Artemia. A las 72 h después de la eclosión se observó el esbozo de la aleta pélvica y a las 240 h se completó la metamorfosis.