Microbiome-Related and Infection Control Approaches to Primary and Secondary Prevention of Clostridioides difficile Infections.

Clostridioides difficile infections (CDIs) have decreased in the past years, but since 2021, some hospitals have reported an increase in CDI rates. CDI remains a global concern and has been identified as an urgent threat to healthcare. Although multiple treatment options are available, prevention strategies are more limited. As CDI is an opportunistic infection that arises after the normally protective microbiome has been disrupted, preventive measures aimed at restoring the microbiome have been tested. Our aim is to update the present knowledge on these various preventive strategies published in the past five years (2018-2023) to guide clinicians and healthcare systems on how to best prevent CDI. A literature search was conducted using databases (PubMed, Google Scholar, and clinicaltrials.gov) for phase 2-3 clinical trials for the primary or secondary prevention of CDI and microbiome and probiotics. As the main factor for Clostridium difficile infections is the disruption of the normally protective intestinal microbiome, strategies aimed at restoring the microbiome seem most rational. Some strains of probiotics, the use of fecal microbial therapy, and live biotherapeutic products offer promise to fill this niche; although, more large randomized controlled trials are needed that document the shifts in the microbiome population.

Application of different microcarrier cell culture technologies in biological product field / 中国生物制品学杂志

@#The productivity of cells per unit area determines the scale-up potential of the cell culture process,and the largescale application of the microcarrier system provides space for the high-yield culture of anchorage-dependent animal cells. The microcarrier animal cell culture technology is suitable for efficient production process development and optimized amplification. In recent years,microcarrier-based culture technology has been widely used in various types of animal cell culture to produce many important biological products such as vaccines,enzymes,hormones,antibodies,interferons and other probiotics. In this paper,the research progress of domestic and foreign microcarrier cell culture technology,the comparison of new microcarriers and traditional microcarriers and their applications were reviewed,so as to provide reference for the in-depth research and application of large-scale cell culture technology based on new microcarriers.

A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA).

INTRODUCTION: There is growing interest in the development of multiple presentations for biological products for subcutaneous (SC) injection for life cycle management and product differentiation. Bridging clinical studies are required to extrapolate the existing data package to new presentations. AREAS COVERED: This review compiles information of bridging clinical studies conducted for biological products administered by the SC route and approved in more than one presentation by the United States Food and Drug Administration's Center for Drug Evaluation and Research up until 31 December 2021. Information regarding indication(s), presentation(s), approval pathways, approval timelines, and various aspects of bridging clinical studies was collected from published documents. EXPERT OPINION: The type of bridging clinical study can depend on the extent of differences between presentations, existing data packages, and the stage of the product development. Design of a bridging clinical study should be based on the characteristics of a biological product and should be aimed at detecting the relevant differences between presentations. Single-dose comparative pharmacokinetics in normal healthy volunteers is the most common bridging clinical study design. Covariates like body weight and injection site should be considered during the design of these studies. The impact of the different user interfaces of presentations should also be considered.

Current status of biosimilars in Turkey: A survey among medical oncologists.

INTRODUCTION: To evaluate biosimilar understanding and preference trends of medical oncologists in Turkey. METHODS: A survey consisting of 24 multiple-choice questions with checkbox answers was conducted among medical oncologists. The questionnaire was divided into five parts to some intentions: demographic characteristics, general knowledge about biosimilars, knowledge about local approval and reimbursement issues, individual preference trends, and ranking the knowledge of their own. All answers were analyzed as whole cohort, specialists and fellows. RESULTS: Fellows (n = 47) consisted 42%, and academic clinicians (n = 37) consisted 35% of the participants. In the whole cohort, the overall rate of correct answers was 55.1% in the general knowledge about the biosimilars part, and 26.7% in the local approval and reimbursement issues part. At all, 57.7% of the participants declared that they object to switch from a reference product to a biosimilar product. The rate of those who defined themselves as extremely knowledgeable decreased from 8.1% to 2.7% in the whole cohort at the end of the survey. CONCLUSION: The need for more accurate and clarified local regulations and education emerging in the biotechnology era must be met.

Biosimilars according to Jordan Food and Drug Administration regulations.

In 2015, JFDA approved its biosimilars registration guidelines [1] officially. Many steps have been taken before achieving this progress. This paper summarizes briefly JFDA efforts that were done in the previous years and the actions taken to approve JFDA biosimilars registration guidance which was based on EMA related guidelines [2-5], and its impact on enhancing the affordability of safe, effective and high quality biosimilars for patients.

Investigation of the Behavioral Model of Suppliers of Raw Materials for Biological Products with a System Dynamics Approach (Case study: Razi Vaccine and Serum Research Institute).

The dynamic and variable environment of today's business has created a highly competitive atmosphere; n order for organizations to survive and succeed, they need to provide new and efficient methods in all aspects of their work. Therefore, supply chain management, as one of the effective factors in the quality of performance of the organization, has been an especial area of attention and since the quality of the final product is strongly dependent on the raw materials of the product and the efficiency of the supplier, the suppliers' proper performance will guarantee the stability of the supply chain. One of the major challenges for managers in a dynamic and uncertain environment is identifying supplier evaluation indicators, and this article tries to provide a reliable approach to this important challenge. Therefore, the main purpose of this paper is to investigate of behavioral model of suppliers of raw materials for biological products with a system dynamics approach. Accordingly, the reliability and accuracy of the proposed model has been evaluated by several statistical tests. Finally, the performance of this model is shown in the supply chain of Razi Vaccine and Serum Research Institute. The results obtained both in the tests and in the case study, all indicate the ability, reliability and high accuracy of the model in suppliers' evaluation.

Cord blood beyond transplantation: can we use the experience to advance all cell therapies?

Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation.

Similarity of Response to Biologics Between Elderly-onset Rheumatoid Arthritis (EORA) and Non-EORA Elderly Patients: From the FIRST Registry.

OBJECTIVE: Increasing numbers of patients are developing rheumatoid arthritis (RA) at an older age, and optimal treatment of patients with elderly-onset RA (EORA) is attracting greater attention. This study aimed to analyze the efficacy and safety of biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in EORA and non-EORA elderly patients. METHODS: A cohort of patients with RA treated with b/tsDMARDs were retrospectively analyzed. Only patients aged ≥ 60 years were included. Among them, patients who developed RA aged ≥ 60 years were categorized as EORA, whereas those aged < 60 years were categorized as non-EORA elderly. Disease activity was compared between the EORA and non-EORA elderly groups. RESULTS: In total, 1040 patients were categorized as EORA and 710 as non-EORA elderly. There were no significant differences in characteristics at baseline between the 2 groups. The proportion of patients with low and high disease activity was comparable at Weeks 2, 22, and 54 between the EORA and the non-EORA elderly group. There were no significant differences in the reasons for the discontinuation of b/tsDMARDs between the 2 groups. Elderly RA onset did not affect changes in Clinical Disease Activity Index (CDAI) and Health Assessment Questionnaire-Disability Index, nor did it affect the reasons for b/tsDMARD discontinuation between the 2 groups. The trajectory analysis on CDAI responses to b/tsDMARDs for 54 weeks identified 3 response patterns. The proportion of patients categorized into each group and CDAI response trajectories to b/tsDMARDs were very similar between EORA and non-EORA elderly patients. CONCLUSION: CDAI response patterns to b/tsDMARDs and HR of adverse events were similar between EORA and non-EORA elderly patients.

Dose Reduction of Tumor Necrosis Factor Inhibitor and its Effect on Medical Costs for Patients with Ankylosing Spondylitis.

INTRODUCTION: Tumor necrosis factor inhibitors (TNFis) may be administered at a reduced dose to patients with ankylosing spondylitis (AS) for various reasons. However, in practice, there is insufficient evidence of how the dose reduction of TNFi is implemented and the amount of medical costs it reduces. In this study, we investigated treatment patterns among patients with AS who were administered various TNFis. The effect on medical costs related to AS was also investigated using Korea's insurance claims database. METHODS: From the insurance claims database of the Health Insurance Review & Assessment Service in South Korea, patients with AS newly treated with TNFis (etanercept, adalimumab, golimumab, and infliximab) between July 1, 2013, and June 30, 2016, were enrolled. Patients treated with the TNFis were followed up for 2 years. Treatment patterns (continuation and discontinuation of TNFi) and dose reduction (< 50% of recommended dose) in patients who continued treatment were analyzed and compared among the TNFi groups using the Chi-square test. Healthcare costs between the dose reduction and maintenance groups were compared using general linear modeling. RESULTS: Of 1352 patients, 764 (56.51%) continued using TNFis for 2 years, and 17.8% of these were administered reduced doses. TNFi dose reduction was the most frequent in 36 (24.83%) patients using etanercept, followed by those using adalimumab (21.97%), golimumab (11.70%), and infliximab (11.98%) (p = 0.0028). For each TNFi group, the total healthcare cost significantly decreased, that is, by 24.85% for adalimumab, 31.80% for etanercept, 26.34% for golimumab, and 35.52% for infliximab (p < 0.0001). CONCLUSIONS: TNFi dose reduction was identified in 17.8% of the patients with AS, and the patterns were different for each TNFi. Additionally, the dose reductions significantly reduced the medical costs associated with AS, that is, from 24.85 to 35.52% of the total medical expenditure.

Factores de crecimiento en el plasma: herramienta terapéutica en dermatología / Growth factors in plasma: therapeutic tool in dermatology

Las plaquetas contienen una gran cantidad de factores de crecimiento que participan en los procesos de cicatrización tisular. Entre ellos, el factor de crecimiento derivado de las plaquetas (PDGF), el factor de crecimiento transformante (TGF), el factor plaquetario 4 (PF4), la interleucina (IL)-1, el factor angiogénico derivado de las plaquetas (PDAF), el factor de crecimiento endotelial (VEGF), el factor de crecimiento epidérmico (EGF), el factor de crecimiento endotelial derivado de las plaquetas (PDEGF), el factor de crecimiento de células epiteliales (ECGF) y el factor de crecimiento similar a la insulina (IGF). El plasma rico en plaquetas (PRP) es un derivado sanguíneo concentrado de la sangre total con una alta concentración de plaquetas. Otro componente esencial del PRP son las proteínas que actúan a nivel de la adhesión celular (fibrina, fibronectina y vitronectina), que proporcionan el soporte estructural necesario para la migración celular y para la proliferación y crecimiento tridimensional de los tejidos sobre los que actúa. La fibrina es la forma activada del fibrinógeno, sustrato final de todas las reacciones de coagulación, se transforma en fibrina insoluble por acción de la trombina. El gel de fibrina polimerizado constituye la primera matriz cicatricial de las heridas. Tanto el plasma rico en plaquetas como las mallas de fibrina varían en la composición y concentración de factores de crecimiento, proteínas y citocinas. En este trabajo se revisan las características de estos productos biológicos, su aplicación en dermatología así como los principales requisitos para su preparación(AU)

Platelets contain a large amount of growth factors involved in the processes of tissue healing. Among them, plateletderived growth factor (PDGF), transforming growth factor (TGF), platelet factor 4 (PF4), interleukin (IL) -1, angiogenic factor derived from platelets (PDAF) , the endothelial growth factor (VEGF), the epidermal growth factor (EGF), the plateletderived endothelial growth factor (PDEGF), the epithelial cell growth factor (ECGF) and the Insulin like growth factor (IGF). Platelet-rich plasma (PRP) is a concentrated whole blood derivate with a high concentration of platelets. Another essential component of PRP are proteins acting on cell adhesion (fibrin, fibronectin and vitronectin), which provide the structural support necessary for cell migration and proliferation as well as three-dimensional growth of the tissues on which they act. Fibrin is the activated form of fibrinogen, the final substrate of all coagulation reactions. It is transformed into insoluble fibrin by the action of thrombin. The polymerized fibrin gel constitutes the first cicatricial matrix of wounds. Both plateletrich plasma and fibrin meshes vary in the composition and concentration of growth factors, proteins and cytokines. In this work we review the characteristics of these biological products, their application in dermatology as well as main requirements for their preparation(AU)

[Advances in application of capillary electrophoresis in pharmaceutical analysis].

Capillary electrophoresis (CE) is mainly applied in pharmaceutical analysis. All CE separation modes and detection methods show their characteristics and application abilities in the separation and analysis of different drug samples. The present review provides a brief cross section of new advances in CE application in pharmaceutical analysis, including for small molecular drugs and related substances (including chiral drug separation), traditional Chinese medicine and natural products, in vivo pharmaceutical analysis, and biological product analysis. However, the research on physical and chemical constant determination, affinity capillary electrophoresis and binding constant research (drug and receptor interaction, etc.), clinical biomarker analysis, metabolomics, and microchip CE analysis are not included. According to traditional pharmaceutical analysis developments, the recent advances in CE in compliance with pharmaceutical analysis regulatory requirements include CE capacitively coupled contactless conductivity detection (C4D), improved detection sensitivity and precision, CE-sodium dodecyl sulfate (CE-SDS), imaged capillary isoelectric focusing (icIEF), antibody analysis, and so on. Combined with the references, this review also discusses the current requirements in the field of traditional pharmaceutical analysis, as well as the status, challenges and opportunities of CE in it. Some suggestions on CE application as a complementary analysis method for chemical drugs and traditional Chinese medicine analysis are put forward, and the characteristics and ability of CE in biological product analysis is expected to further development. The new development of CE-MS and improvement of CE repeatability may greatly expand the field of application of CE in the future. This review covers the improvements published between January 2017 and February 2020, as well as some important CE papers published in 2016.

Study on the Effects of the Deregulation of Drug Price Control on Drug Price / 中国药房

OBJECTIVE：To study the effects of the deregulation of drug price control on drug price ，and to provide reference for policy formulation. METHODS ：The quarterly price data of 46 875 chemical and biological products （measured by fixed Laspeyres index ）were collected from 788 sample hospitals from the database of National Medical Economic Information Network during Jan. 2012 to Jun. 2017. Based on the interrupted time series model ，changes in the prices of overall situation of chemicals and biological products ，as well as the sub-group ，ie. low-cost drugs ，original and imitated drugs were analyzed after the government’s policies of canceling the price limit control and strengthening the price monitoring （including Notice on Printing and Distributing the Opinions on the Supply and Guarantee of Commonly Used Low-cost Drugs in 2014，Notice on Printing and Distributing the Opinions on Promoting the Reform of Drug Prices in 2015，etc.），returning to market competition ；the effects of canceling the price limit control on drug price were put forward. RESULTS & CONCLUSIONS ：After government deregulation for maximum retail price limit of commonly used low-priced drugs ，the price of low-priced drugs increased substantially （β3＝1.11×10－2， P＝0.008）. After the total abolition of drug price control ，there was no significant change in the overall chemical and biological products（β3＝－1.85×10－3，P＝0.175）and sub-group （low-cost drugs ：β3＝1.10×10－3，P＝0.066；original drugs ：β3＝－7.20×10－4， P＝0.549；generic drugs ：β3＝6.78×10－4，P＝0.784）drug prices. Within two years after government deregulation policy in 2015， drug prices and the drug market had remained stable. It can be seen that it is feasible for canceling the government ’s pricing and opening the price control in the mature market so as to make the price formulation return to the market ，combined with the government strengthening the price monitoring.

The effect of natural products in animal models of temporomandibular disorders

Abstract Treatment of temporomandibular disorders (TMD) is a challenge for health care professionals. Therefore, new approaches have been investigated, such as the use of natural products. Objective This systematic review aims to summarize the natural products used in treatment of experimental models of TMD. Methodology A systematic search was performed in the databases Medline, Web of Science, Scopus, Embase, SciELO, LILACS, and Scholar Google databases in January 2020, dating from their inception. Pre-clinical studies with natural products for intervention in experimental TMD were included. Two reviewers independently selected the studies, extracted the data, and evaluated the risk of bias. Results 17 records were selected, and 17 different natural products were found, including three lectins, three plants or algae extracts, three sulfated polysaccharides, three cocoa preparations, and five isolated compounds. Concerning the risk of bias, most studies lacked on randomization and blinding. Nociception induced by phlogistic agents was evaluated in most articles, and in five studies it was associated with analysis of inflammatory parameters. In order to investigate the mechanism of action of the natural products used, eight studies evaluated expression of neural or glial molecular markers. Conclusions 16 of 17 natural products found in this review presented positive results, showing their potential for treatment of TMD. However, the lack of methodological clarity can influence these results.

Current Perspectives on Ligand-Binding Assay Practices in the Quantification of Circulating Therapeutic Proteins for Biosimilar Biological Product Development.

Bioanalysis in biosimilar biological product development (BPD) plays a critical role in demonstrating pharmacokinetic (PK) similarity across products. The 2018 FDA Bioanalytical Method Validation guidance for industry provides general principles in the development, validation, and conduct of bioanalytical assays. Given that the PK similarity assessment in BPD programs involves two or more non-identical products, there are additional considerations for bioanalytical methods. Here in, we provide our perspectives on the definition of (1) a single bioanalytical method in the context of BPD in supporting a PK similarity study, (2) bioanalytical method comparability during accuracy and precision experiments to determine the potential bias difference prior to assessing other validation parameters, and (3) bioanalytical method validations that support PK similarity assessments.

Development and multiplication of Eisinea andrei in the manure of cattle subjected to high Trichoderma doses / Desenvolvimento e multiplicação de Eisenia andrei em esterco bovino em altas doses de Trichoderma

The efficacy of the vermicomposting and products based on the antagonistic fungus and plant growth promoter trichoderma (Trichoderma spp) is well known and studied in organic agriculture. However, for a better methodological efficiency are necessary studies to evaluate the effect of high doses of these bioproducts in the biology and development of earthworms. Thus, the present work aims to test the use of high commercial biocontrol product (ICB Nutrisolo Trichoderma) doses by evaluating the multiplication and development of Eisenia andrei. Changes in the chemical features of the substrate produced by the vermicomposting process using in natura and sterilized organic cattle manure were also assessed. Each experimental unit consisted of 6 kg of substrate (in multipurpose polypropylene box ­ 20 x 40 x 50 cm) containing 48 clitelate adult Eisenia andrei earthworms. ICB Nutrisolo Trichoderma was used as biological agent along with eight strains of the following species: T. koningiopsis, T. asperellum and T. harzianum. The following treatments were applied at doses of 1011 CFU kg-1 of ICB Nutrisolo Trichoderma in the presence of earthworms: T1 (0.5); T2 (1.0); T3 (2.0); T4 (4.0); T5 (8.0) and T6 (0.0). The T7 treatment was herein used in order to evaluate the chemical features of the vermicompost. It was a completely randomized design with four replications per treatment. The temperature was kept at 28°C and humidity ranged between 60 and 70%. After 60 days, the number of young and adult earthworms, and cocoons was counted; then, their dry biomass was assessed. The results found in the lethality test showed decrease in the number of earthworms treated with 4.0x1011 CFU kg-1 of ICB. The biological product doses up to 1.0x1011 CFU kg-1 did not alter the number of adult earthworms and cocoons, or the multiplication index of E. andrei in cattle waste vermicomposts. There was no influence of the tested doses on earthworms' individual development. However, doses above 2.0x1011 CFU kg-1 decreased their total biomass. The C/N ratio for all treatments indicates maturity within acceptable results for organic compounds.

A eficácia da vermicompostagem e de bioprodutos à base do fungo antagonista e promotor de crescimento vegetal trichoderma (Trichoderma spp) é bem conhecida e estudada na agricultura orgânica. Entretanto, para uma melhor eficiência metodológica, são necessários estudos que possam avaliar a interferência de altas doses desses bioprodutos na biologia e desenvolvimento das minhocas. Baseado nesse contexto, o objetivo deste trabalho foi testar altas doses do produto comercial biológico ICB Nutrisolo Trichoderma (ICB), avaliando-se a multiplicação e desenvolvimento de Eisenia andrei, bem como alterações nas características químicas do substrato produzido no processo de vermicompostagem, a partir do resíduo orgânico esterco bovino. O esterco bovino in natura foi autoclavado a 121°C, por duas vezes, em um intervalo de 24 h. A unidade experimental constituiu-se de 6 kg de substrato condicionados em caixa multiuso de polipropileno, com dimensões 20 x 40 x 50 cm, contendo 48 minhocas adultas e cliteladas da espécie E. andrei. Como agente biológico, utilizou-se o produto comercial ICB na forma de fluído, composto por oito cepas das espécies T. koningiopsis, T. asperellum e T. harzianum, com as seguintes doses nos tratamentos a seguir: T1 (0.5); T2 (1.0); T3 (2.0); T4 (4.0); T5 (8.0); e T6 (0.0), sendo todas as concentrações em 1011 UFC kg-1 do produto em vermicomposto, e, para a avaliação das características químicas do vermicomposto em altas doses do produto ICB, foi utilizado também o T7 (somente substrato). O delineamento foi inteiramente casualizado com quatro repetições por tratamento. A temperatura foi mantida a 28ºC e a umidade entre 60 e 70%. Após 60 dias do início da instalação, fez-se a contagem do número de minhocas adultas, jovens e casulos; posteriormente, avaliou-se o seu peso seco total. Os resultados observados no teste de letalidade mostram que, somente a partir de 4.0x1011 UFC kg-1 de ICB, há decréscimo do número de minhocas. Doses altas até 1.0x1011 UFC kg-1 do produto não alteram o número de minhocas adultas e de casulos de E. andrei em vermicompostagem com esterco bovino, entretanto, o índice de multiplicação foi inferior em todos os tratamentos com o produto. Doses acima de 2.0x1011 UFC kg-1 diminuíram o peso seco total. A relação C/N em todos os tratamentos indica maturidade dentro de resultados aceitáveis para compostos orgânicos.

Functional Modulation of Tight Junction to Enhance the Permeability of Biological Products (Biologics) in Biomembranes.

In recent years, biological products (biologics), including blood components, recombinant therapeutic proteins, antibodies, gene therapeutic materials, and so on, have been produced by biotechnology methods and other novel technologies. These products are essential therapeutic materials in progressive medicine. However, we often encounter the lower permeability of these biologics through biomembranes, due to their high molecular mass. In the last three decades, we have investigated drug delivery systems, including several enhancement methods for the permeability of biologics such as recombinant therapeutic proteins and viral vectors in epithelial cells. This review focuses the development of novel delivery systems for biologics in rectal and nasal administration, and includes an interesting observation of modulators of the tight junction (TJ) function. From cellular biology perspective, the interaction between permeability enhancing materials and targeted molecules in the TJ of epithelial cells was investigated. We elucidated that a TJ modulator will interact with a major constituent protein, for instance claudins, in playing an essential role in the tissue-specific barrier function of the TJ. Furthermore, useful enhancement of gene transfer in cells (for instance, in Caco-2 cells) was found in the combination of an adenovirus vector and capric acid sodium salt (C10), a TJ modulator.

Rhizobacterial characterization for quality control of eucalyptus biogrowth promoter products

Abstract Plant growth-promoting rhizobacteria strains from special formulations have been used to optimize eucalyptus cutting production. To undertake quality control for the formulated products, the rhizobacterial strains should be characterized to assess their purity and authentication. In the present study, we characterized nine strains of rhizobacteria, including three Bacillus subtilis (S1, S2 and 3918), two Pseudomonas sp. (MF4 and FL2), P. putida (MF2), P. fulva (Ca), Frateuria aurantia (R1), and Stenotrophomonas maltophilia (CIIb). The strains were differentiated by colony morphology after 24 h of incubation in three different solid state culture media (glucose-nutritive agar, 523 medium and yeast extract-mannitol agar), sensitivity to a panel of 28 antibiotics (expressed according to the formation of inhibition halos of bacterial growth in the presence of antibiotics), and PCR-RFLP profiles of the 16S rDNA gene produced using nine restriction enzymes. It was possible to differentiate all nine strains of rhizobacteria using their morphological characteristics and sensitivity to antibiotics. The molecular analysis allowed us to separate the strains CIIb, FL2 and R1 from the strains belonging to the genera Bacillus and Pseudomonas. By using these three methods concomitantly, we were able to determine strain purity and perform the authentication.

Rhizobacterial characterization for quality control of eucalyptus biogrowth promoter products.

Plant growth-promoting rhizobacteria strains from special formulations have been used to optimize eucalyptus cutting production. To undertake quality control for the formulated products, the rhizobacterial strains should be characterized to assess their purity and authentication. In the present study, we characterized nine strains of rhizobacteria, including three Bacillus subtilis (S1, S2 and 3918), two Pseudomonas sp. (MF4 and FL2), P. putida (MF2), P. fulva (Ca), Frateuria aurantia (R1), and Stenotrophomonas maltophilia (CIIb). The strains were differentiated by colony morphology after 24h of incubation in three different solid state culture media (glucose-nutritive agar, 523 medium and yeast extract-mannitol agar), sensitivity to a panel of 28 antibiotics (expressed according to the formation of inhibition halos of bacterial growth in the presence of antibiotics), and PCR-RFLP profiles of the 16S rDNA gene produced using nine restriction enzymes. It was possible to differentiate all nine strains of rhizobacteria using their morphological characteristics and sensitivity to antibiotics. The molecular analysis allowed us to separate the strains CIIb, FL2 and R1 from the strains belonging to the genera Bacillus and Pseudomonas. By using these three methods concomitantly, we were able to determine strain purity and perform the authentication.

A clinician's guide to biosimilars in oncology.

Biological agents or "biologics" are widely used in oncology practice for cancer treatment and for the supportive management of treatment-related side effects. Unlike small-molecule generic drugs, exact copies of biologics are impossible to produce because these are large and highly complex molecules produced in living cells. The term "biosimilar" refers to a biological product that is highly similar to a licensed biological product (reference or originator product) with no clinically meaningful differences in terms of safety, purity, or potency. Biosimilars have the potential to provide savings to healthcare systems and to make important biological therapies widely accessible to a global population. As biosimilars for rituximab, trastuzumab, and bevacizumab are expected to reach the market in the near future, clinicians will soon be faced with decisions to consider biosimilars as alternatives to existing reference products. The aim of this article is to inform oncology practitioners about the biosimilar development and evaluation process, and to offer guidance on how to evaluate biosimilar data in order to make informed decisions when integrating these drugs into oncology practice. We will also review several biosimilars that are currently in development for cancer treatment.

Overviews and analysis to the U. S. FDA's new approvals in 2012 / 国际药学研究杂志

In 2012, the U. S. Food and Drug Administration (FDA) approved 34 new drugs, including 23 new molecular enities and 11 new biological products. According to he prescription nformation for professionals, this article briefly describes he description, mechanism of action, the box warning, indications and usage, dosage and administration, dosage form and strength, contrandications, warning and precautions, adverse reactions, drug nteraction and use of these new drugs n special population. In addiion, the first events n he history of new drug research, development and approval are also discussed.