• Journal of Korean Society for Quality Management
• /
• v.49 no.2
• /
• pp.145-159
• /
• 2021

Purpose: A statistical similarity evaluation to compare pharmacokinetics(PK) profile data between nonclinical and clinical experiments has become a significant issue on many drug development processes. This study proposes a new similarity index by considering important parameters, such as the area under the curve(AUC) and the time-series profile of various PK data. Methods: In this study, a new profile similarity index(PSI) by using the concept of a process capability index(Cp) is proposed in order to investigate the most similar animal PK profile compared to the target(i.e., Human PK profile). The proposed PSI can be calculated geometric and arithmetic means of all short term similarity indices at all time points on time-series both animal and human PK data. Designed simulation approaches are demonstrated for a verification purpose. Results: Two different simulation studies are conducted by considering three variances(i.e., small, medium, and large variances) as well as three different characteristic types(smaller the better, larger the better, nominal the best). By using the proposed PSI, the most similar animal PK profile compare to the target human PK profile can be obtained in the simulation studies. In addition, a case study represents differentiated results compare to existing simple statistical analysis methods(i.e., root mean squared error and quality loss). Conclusion: The proposed PSI can effectively estimate the level of similarity between animal, human PK profiles. By using these PSI results, we can reduce the number of animal experiments because we only focus on the significant animal representing a high PSI value.

• Journal of Microbiology and Biotechnology
• /
• v.29 no.9
• /
• pp.1335-1340
• /
• 2019

Probiotics, including bacteria and yeast, are live microorganisms that have demonstrated beneficial effects on human health. Recently, probiotic bacteria are constantly being studied and their applications are also being considered in promising adjuvant treatments for various intestinal diseases. Clinical trials and in vivo experiments have extended our current understanding of the important roles that probiotics play in human gut microbiomeassociated diseases. It has been documented through many clinical trials that probiotics could shape the intestinal microbiota leading to potential control of multiple bowel diseases and promotion of overall wellness. In this review, we focused on the relationship between probiotics and the human gut microbiota and its roles in gut microbiome-associated diseases. Here, we also discuss future directions and research areas that need further elucidation in order to better understand the roles of probiotics in the treatment of intestinal diseases.

• Reproductive and Developmental Biology
• /
• v.36 no.3
• /
• pp.193-198
• /
• 2012

This study was to examine expression of the recombinant full-length adiponectin (recombinant adiponectin) in insect ovarian cell culture system and to characterize structural properties of the recombinant adiponectin secreted in medium. Gene construct encoding the recombinant adiponectin contained N-terminal collagen-like domain (110 Amino Acids, AAs), C-terminal globular domain (137 AAs) and C-terminal peptides for detection with V5 antibody (26 AAs included adaptor peptide) and purification using the 6xHis tag (6 AAs). The approximate molecular weight of the product (monomer) was 35 kDa. Molecular mass species of the expressed recombinant adiponectin were monomer (~35 kDa), dimer (~70 kDa), trimer (~105 kDa) and hexamer (~210 kDa). The major secreted species were the LMW forms, such as monomer, dimer, and trimer. There was MMW of hexamer as minor form. HMW multimers (~300 kDa) were shown as a tracer or not detected on the SDS-PAGE in several experiments (data not shown). The multimer forms in this study were not compatible to those in animal or human serum and adipose tissue by other researcher's study in which the major multimer forms were HMW. By protein denaturing experiments with reducing reagent (${\beta}$-MeOH), anionic detergent (SDS) and heat ($95^{\circ}C$) on the SDS-PAGE, not all adiponectin multimers seemed to have disulfide bond linked structure to form multimers. The recombinant adiponectin which expressed in insect ovarian cell culture system seemed to have the limitation as full physiological regulator for the application to animal and human study.

• Clinical and Experimental Pediatrics
• /
• v.55 no.6
• /
• pp.193-201
• /
• 2012

Atopic dermatitis (AD) is an immune disorder that is becoming increasingly prevalent throughout the world. The exact etiology of AD remains unknown, and a cure for AD is not currently available. The hypothesis that appropriate early microbial stimulation contributes to the establishment of a balanced immune system in terms of T helper type Th1, Th2, and regulatory T cell (Treg) responses has led to the use of probiotics for the prevention and treatment of AD in light of various human clinical studies and animal experiments. Meta-analysis data suggests that probiotics can alleviate the symptoms of AD in infants. The effects of balancing Th1/Th2 immunity and enhancing Treg activity via the interaction of probiotics with dendritic cells have been described in vitro and in animal models, although such an effect has not been demonstrated in human studies. In this review, we present some highlights of the immunomodulatory effects of probiotics in humans and animal studies with regard to their effects on the prevention of AD.

• Journal of The Association for Neo Medicine
• /
• v.1 no.2
• /
• pp.15-30
• /
• 1996

In the study about the logical basis and interpreting methods of animal experiments using rats in traditional medicine, several conclusions are obtained and summarized as following. 1. The logical basis of the animal experiments in traditional medicine is the essential homogeneity between human and rat defined as various transformation of one Qi(一氣) packed the cosmos. 2. Morphologically, the rat has abundant Yin(陰) and less Yang(陽) in most of anatomical characteristics. 3. Physiologically, the rat has unstable heart and mild temper with good fertility, which shows the features of Yin animal. 4. Pathologically, the rat shows the pathology of injury of viscera by stresses(氣激傷臟) and pathological transformations of internal water(痰飮水濕) mainly. 5. Constitutionally, the rat is alike to water type man(水形人) or Soeumin(小陰人) out of Yin Ren(陰人). 6. So, the rat is the proper experimental animal for diseases of sputum and water, emotional stimulations, endocrine system, heart, kidney, Yin syndrome(陰證) etc..

• Journal of Animal Science and Technology
• /
• v.63 no.2
• /
• pp.272-280
• /
• 2021

Cumulus-oocyte complexes (COCs), which contain immature oocytes, are matured in vitro for in vitro embryo production. Oocyte and cumulus cells are then separated using hyaluronidase. To date, there have only been a few reported cases of the toxic effects of hyaluronidase on porcine oocytes. The aim of this study was to compare the effects of bovine testis-derived hyaluronidase and recombinant human hyaluronidase on oocyte denudation and quality. Porcine COCs were matured for 44 h and denuded using different hyaluronidase concentrations and exposure times. Then, oocytes were activated by electrical parthenogenesis. In experiment 1, COCs were denuded using bovine-derived, ovine-derived (Hirax), and human recombinant (ALT-BC4) hyaluronidases for 10 and 20 min. In experiment 2, bovine-derived and human recombinant (ALT-BC4 and ICSI Cumulase®) hyaluronidases were used to denude the COCs for 2 and 20 min. In both experiments the oocytes were all completely denuded, and there was no degeneration. Rate of embryo development was significantly increased in group treated ALT-BC4 for 2 min and not significantly different in other treatment groups. In general it slightly decreased with longer exposure times. These results have confirmed that different sources of hyaluronidase do not have detrimental effects on the quality of porcine oocytes and suggest that the human recombinant hyaluronidase ALT-BC4 is suitable for oocyte denudation with an increased blastocyst rate.

• The Journal of Pediatrics of Korean Medicine
• /
• v.26 no.1
• /
• pp.16-35
• /
• 2012

Objectives The purpose of this study is to investigate various treatments in Japan for atopic dermatitis. The treatments on atopic dermatitis from diet modification and kampo medicine were studied for 11 years (from 2001 to 2011). Methods The search database includes PubMed. To narrow the search, the following key search terms were used: 'atopic dermatitis, diet, japan', 'atopic dermatitis, kampo, japan'. The search was limited to the publication date from 2001 to 2011. Results 1. There are 16 studies on atopic dermatitis treatment by using diets - 2 clinical trials and 12 animal experiments. All researches have revealed that diet modification is effective for atopic dermatitis. 2. There are 6 studies on atopic dermatitis treatment by using kampo medicine - 2 clinical trials and 4 animal experiments. All researches have revealed that kampo medicine is effective for atopic dermatitis. 3. There are 4 studies on atopic dermatitis treatment by using herbs - 4 animal experiments. All researches have revealed that herb is effective for atopic dermatitis. Conclusions Most of the animal experiments were using mice, so the studies on safety and effectiveness are needed to be confirmed to human as well. In the future, systematic guidelines and protocols are necessary for clinical trials and development of successful treatments on atopic dermatitis is needed.

• Clinical and Experimental Reproductive Medicine
• /
• v.6 no.1_2
• /
• pp.29-36
• /
• 1979

A good animal model that simulates the human subject has not been available for the evaluation of the in vivo effectiveness of vaginal contraceptives. After careful consideration, The stumptailed macaque (Macaca arctoides) was studied for its applicability since it has a reproductive tract similar to that of the woman, is easy to handle, does not require tranquilization or anesthesia when the contraceptive is deposited, and breeds and conceives readily under caged conditions. The reported observations show the usefulness of this animal. Both postcoital sperm motility studies and breeding experiments were performed with the use of Delfen vaginal cream and K-Y jelly. K-Y jelly had no effect on the motility of vaginal spermatozoa or on the conception rate of the primates. Although Delfen vaginal cream consistently immobilized all spermatozoa in the postcoital test, half of the animals became pregnant within an average of 3.7 breeding cycles. These results illustrate the discrepancy between spermicidal tests and fertility measurements, and it is recommended that primate-breeding experiments be performed before a spermicide is evaluated in women as a contraceptive. (AM J. OBSTET. GYNECOL, 129:368, 1977.)

• Environmental Analysis Health and Toxicology
• /
• v.31
• /
• pp.26.1-26.9
• /
• 2016

Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

• Asian-Australasian Journal of Animal Sciences
• /
• v.17 no.10
• /
• pp.1344-1349
• /
• 2004

Titin-cap (TCAP), one of the abundant transcripts in skeletal muscles, was nvestigated in this study in cattle because of its role in regulating the proliferation and differentiation of myoblasts by interacting with the myostatin gene. From the 5, and 3, RACE experiments, full-length TCAP coding sequence was identified, comprising 166 amino acids. The amino acid comparison showed high sequence similarities with previously identified human (95.8%) and mouse (95.2%) TCAP genes. The TCAP expression, addressed by northern blot, is limited in muscle tissues as indicated by Valle et al. (1997). The radiation hybrid analysis localized the gene on BTA19, where the comparative human and porcine counterparts are on HSA17 and SSC12. A few muscle-related genetic disorders were mapped on HSA17 and some growth-related QTLs were identified on SSC12. The bovine TCAP gene found in this study opens up new possibilities for the investigation of muscle-related genetic diseases as well as meat yield traits in cattle.