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Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

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Journal of pharmaceutical Analysis 2024年第6期14卷 785-804页

作者： Patanachai K.Limpikirati Sorrayut Mongkoltipparat Thinnaphat Denchaipradit Nathathai Siwasophonpong Wudthipong Pornnopparat Parawan Ramanandana Phumrapee Pianpaktr Songsak Tongchusak Maoxin Tim Tian Trairak Pisitkun Department of Food and pharmaceutical Chemistry Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand pharmaceutical sciences and Technology(PST)Graduate Program Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand Center of Excellence in Systems Biology(CUSB) Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand Department of pharmaceutical Chemistry Faculty of Pharmaceutical SciencesHuachiew Chalermprakiet UniversityBang PhliSamut Prakan10540Thailand Division of Research Affairs Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and *** specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered *** of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance *** attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the *** criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric *** in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial *** are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

关键词： Biopharmaceutical analysis Biopharmaceutical quality control Biopharmaceutical specifications Monoclonal antibodies Protein therapeutics Regulatory science

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Consolidation of a Femoral Neck Fracture in Sickle Cell Disease Patient after Surgical Abstention: A Beneficial and Favorable Outcome

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Surgical Science 2024年第7期15卷 438-443页

作者： Marc Leroy Guifo Albert Desiré Atangana Fouda Faustin Atemkeng Tsatedem Emini Ngono Mengale Ntang Ulrich Bisay Souhe Ginette Kalla faculty of medicine and Biomedical sciences University of Yaound 1 Yaound Cameroon faculty of medicine and pharmaceutical sciences University of Dschang Dschang Cameroon faculty of medicine and pharmaceutical sciences University of Ebolowa Ebolowa Cameroon

Femoral neck fracture is classically a traumatic pathology in the elderly but it can also occur in young people during a road traffic accident or occasionally when the femoral neck has been weakened by a pathological process. In sickle cell patients, the hip is often subjected to aseptic necrosis. The authors report the case of the child NL, aged 5 years and 4 months in whom a fracture of the femoral neck classified Delbet 3 was found as well as his sickle cell status discovered and in whom treatment by surgical abstention was carried out with a favorable evolution. This association of factors of the femoral head necrosis or nonunion is unusual and confirms the osteogenetic potential of a child. However, monitoring is necessary because other anomalies may reveal themselves.

关键词： Sickle Cell Disease Fracture Femoral Neck Osteomyelitis

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The Hidden Side of the Story between the Placenta and Preeclampsia: Preliminary Results of a Prospective Cohort of Pregnant Women in Cameroon

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Open Journal of Obstetrics and Gynecology 2024年第4期14卷 610-620页

作者： Junie Annick Metogo Ntsama Ambroise Merci Engounou Seme Urielle Julie Tchuente Sutchueng Wilfried Loic Tatsipie Christian Vagoda Henry-Leonard Chatelin Mol Madye Ngo Dingom Felix Essiben Cyrille Claude Noa Ndoua Yann chris Eng Odile Fernande Zeh faculty of medicine and Biomedical sciences University of Yaound&#233 I Yaound&#233 Cameroon faculty of medicine and pharmaceutical sciences University of Dschang Dschang Cameroon

Introduction: Pre-eclampsia is a complication of pregnancy that generally occurs in the third trimester. It is associated with a maternal and foetal mortality rate of around 27%. In view of the grim picture painted by this condition for both mother and newborn, studies have been carried out into the early detection of patients at risk of developing pre-eclampsia. These make it possible to introduce pregnancy-specific monitoring and preventive strategies to reduce the incidence of the condition. Objective: To establish the link between placental ultrasound characteristics and the onset of pre-eclampsia. Methodology: A multicentre prospective cohort study was conducted in two hospitals in Yaoundé, namely the Yaoundé Gynaecological Obstetrics and Paediatrics Hospital and the Nkolndongo Health and Social Animation Centre, in the gynaecology and radiology departments over a period of 11 months, from October 2022 to August 2023. It included pregnant women who had undergone obstetric ultrasound between 12 and 18 weeks’ gestation. In addition to routine obstetric ultrasound, we performed obstetric Doppler measurements in these patients. The resistance index of the left and right uterine arteries, the umbilical artery and the placental volume were the characteristics sought. At the end of this examination, two groups were formed: cases (pathological Doppler group) and controls (normal Doppler group). Blood pressure and urine dipstick were taken at each antenatal visit until delivery, then during the immediate postpartum period and finally at 7 days, 21 days and 42 days after delivery. Results: Sixty-seven (67) patients were included. Of these, 35 (47.8%) had pathological Dopplers. Sixteen patients had arterial hypertension associated with proteinuria and were therefore labelled as pre-eclampsia (PE). This gives a prevalence of 23.9%. Fifteen (42.8%) of these patients belonged to the exposed group and one to the unexposed group. The mean IR of the pre-eclampsia patients was s

关键词： Pre-Eclampsia Doppler Ultrasound Placenta

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Predictive Factors for Pre-Eclampsia: A Case-Control Study in Two Hospitals in Yaounde

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Open Journal of Obstetrics and Gynecology 2024年第4期14卷 565-574页

作者： Junie Annick Metogo Ntsama Ines Winnie Gouanfo Claude Hector Mbia Wilfried Loic Tatsipie Pascal Mpono Madye Ngo Dingom Felix Essiben Claude Cyrille Noa Ndoua faculty of medicine and Biomedical sciences University of Yaound&#233 I Yaound&#233 Cameroon faculty of medicine and pharmaceutical sciences University of Dschang Dschang Cameroon

Introduction: Pre-eclampsia is a major cause of maternal and prenatal morbidity and mortality, that complicates 2% to 8% of pregnancies worldwide. The aim of this study was to determine the predictive factors for pre-eclampsia in two hospitals in the city of Yaoundé. Methods: A case-control study was conducted at the Gynaecology & Obstetrics department of the Yaoundé Gynaeco-Obstetric and Paediatric Hospital (YGOPH) and the Main Maternity of the Yaoundé Central Hospital (MM-YCH) from February 1 to July 30, 2022. The cases were all pregnant women presenting with pre-eclampsia. The control group included pregnant women without pre-eclampsia. Descriptive statistics followed by logistic regression analyses were conducted with level of significance set at p-value Results: Included in the study were 33 cases and 132 controls, giving a total of 165 participants. The predictive factors for pre-eclampsia after multivariate analysis were: primiparity (aOR = 51.86, 95% CI: 3.01 - 1230.96, p = 0.045), duration of exposure to partner’s sperm Conclusion: The odds of pre-eclampsia increased with primiparity, duration of exposure to partner’s sperm < 3 months, personal history of pre-eclampsia and maternal history of pre-eclampsia. Recognition of these predictor factors would improve the ability to diagnose and monitor women likely to develop pre-eclampsia before the onset of disease for timely interventions.

关键词： Pre-Eclampsia Predictive Factors Yaoundé

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Cardiovascular health awareness,risk perception,behavioural intention and INTERHEART risk stratification among middle-aged adults in Malaysia

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Asian Pacific Journal of Tropical medicine 2024年第2期17卷 61-70页

作者： Siew-Keah Lee Ang-Lim Chua Clement Heng Yew Fong Ban Hao Brian Cong Wen Ling Ng Jing Feng Kong Yik-Ling Chew Kai Bin Liew Yang Shao M.Kandiah faculty of medicine and Health sciences Universiti Tunku Abdul RahmanMalaysia faculty of medicine Universiti Teknologi MARAMalaysia faculty of pharmaceutical sciences UCSI UniversityMalaysia faculty of Pharmacy University of CyberjayaMalaysia The First Affiliated Hospital of Hainan Medical university China

Objective:To investigate the interrelationship between cardiovascular health awareness,risk perception,behavioural intention,and INTERHEART risk stratification in a middle-aged adult population in ***:A cross-sectional survey with convenience sampling was conducted during November 2022 and January *** completed validated questionnaires assessing cardiovascular health awareness,risk perception of cardiovascular diseases,behavioural intention towards adopting healthy habits,and INTERHEART risk stratification score(IHRS)based on established risk factors.A total of 602 respondents were included in the final *** were analysed with independent t-test/one-way ANOVA or Mann-Whitney/Kruskal-Wallis to test the differences,Pearson correlation or linear regression test to analyze the association of independent and dependent ***:There was a significant positive correlation between medical knowledge related to cardiovascular disease(CVD)and knowledge related to CVD risk prevention,risk perception,behavioural intention and IHRS(P<0.05,Pearson correlation).Notably,individuals with higher IHRS tended to have lower knowledge related to CVD and CVD risk prevention,risk perception,and behavioural ***,laborers,active/former smokers,individuals with lower household income and educational levels,those involved in occupations not related to the healthcare sector,and those who did not receive the CVD health brochure or are unaware of health self-assessment tools are likely to have lower levels of knowledge,risk perception,and poorer behavioural intention regarding cardiovascular health(P<0.05,one-way ANOVA).While educational level,smoking status,awareness about CVD poster,self-assessment tools were repeatedly significantly associated with knowledge related to CVD and CVD risk prevention,risk perception,behavioral intention and/or IHRS(P<0.05,linear regression).Conclusions:These findings underscore the importance of promoting car

关键词： Cardiovascular risk Knowledge Risk perception Behavioural intention INTERHEART Middle-aged Lifestyle Physical activity Psychosocial stress

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Co-Morbidities Associated with Prematurity in Two Referral Hospitals in Cameroon

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Open Journal of Pediatrics 2024年第4期14卷 738-753页

作者： Diomede Noukeu Njinkui Dominique Enyama Yolande Djike Fokam Cyrelle O. Mefotse Saha Beatrice Moudze Kaptue Charlotte Eposse Koube Annick A. Tchouamo Sime Christophe Akazong Adjahoung Marthe E. Barla Edgar Mandeng Ma Linwa Seraphin Nguefack faculty of medicine and pharmaceutical sciences of the university of dschang Dschang Cameroon faculty of Health sciences University of Buea Buea Cameroon faculty of Health sciences University of Mountains Bangangte Cameroon Douala Laquintinie Hospital Douala Cameroon faculty of medicine and pharmaceutical sciences University of Douala Douala Cameroon Douala General Hospital Douala Cameroon faculty of medicine and Biomedical sciences University of Yaound I Yaound Cameroon

Introduction: Prematurity is the leading cause of neonatal death in Africa. More than a million children die each year due to co-morbidities related to prematurity. In addition to being one of the causes of neonatal deaths, the health problems associated with prematurity can also lead to severe lifelong impairment in those who survive. Objectives: This paper aims to determine the epidemiology and identify co-morbidities of prematurity in the neonatology units of the Douala General Hospital (DGH) and the Laquintinie Hospital of Douala (LHD). Patients and Methodology: We conducted an analytical retrospective cohort study from January 2015 to January 2018 in the neonatology department of the GDH and the LHD, which are considered reference hospitals for the management of preterm babies in Cameroon. We included all newborns aged less than 37 weeks admitted to the neonatology units of the GDH and the LHD. The descriptive component was based on the analysis of quantitative variables using measures of central tendency. The analytical component was evaluated using Spearman correlations and the Chi-square and Fisher tests. Simple and multiple logistic regressions measured factors predictive of mortality. The Kaplan Meier survival curve used the Log Rank test and significance at p ≤ 0.05. Results: We recorded 908 preterm newborns in neonatal service and 1,124 preterm deliveries in maternity, representing an incidence of 32.5% in neonatal unit and 10.6% in maternity. 51% of whom were girls, given a sex ratio M/F of 0.9. Hypertension was the main prenatal pathology (9.1%), while premature rupture of membranes: PROM (35.5%) and eclampsia/pre-eclampsia (18.6%) were the most common obstetrical pathologies. 75.9% of deliveries were vaginal with 65.2% being performed in our referral hospitals. Gestational age ranged from 22 to 36 weeks, with a mean of 32.4 weeks. Late preterm birth rate was 53.7%, and birth weight varied between 590 and 3200 g with an average of 1747 ± 479 g. The per

关键词： Epidemiology Co-Morbidities Prematurity Douala

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Prevalence of Hepatitis B and Associated Factors in the Garoua Central Prison, Cameroon: A Cross-Sectional Study

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Open Journal of Gastroenterology 2024年第5期14卷 174-183页

作者： Mohamadou Abdou Galdima Adamou Dodo Balkissou Guy Roger Nsenga Djapa Winnie Tatiana Bekolo Nga Gilles Aghoagni Antonin Wilson Ndjitoyap Ndam Ali Abas Mathurin Pierre Kowo Firmin Ankouane Andoulo Dominique Noah Noah Oudou Njoya Servais Albert Fiacre Eloumou Bagnaka faculty of medicine and Biomedical sciences University of Garoua Garoua Cameroon Garoua Regional Hospital Garoua Cameroon faculty of medicine and pharmaceutical sciences University of Dschang Dschang Cameroon faculty de medicine and pharmaceutical sciences University of Douala Douala Cameroon faculty of Health sciences University of Buea Buea Cameroon faculty of medicine and Biomedical sciences University of Yaound&#233 1 Yaound&#233 Cameroon

Introduction: Hepatitis B virus (HBV) infection is a major public health problem in Cameroon. Garoua city is the headquarters of the North Region of Cameroon, where the HBV prevalence is among the highest of the country. The aim of this study was to determine the prevalence of HBsAg carriage and associated factors among persons incarcerated in the Garoua Central Prison. Methods: It was a cross-sectional study conducted from July 1 to July 31, 2023 at the Garoua Central prison. We included all prisoners willing to participate in the study and who gave their verbal consent. We collected data using a pre-established data entry form and we used rapid test for blood screening for HBV surface antigen (HBs Ag) with ELISA confirmation. Data were analyzed using the R® software for Windows. After the univariate analysis, we selected associated variables to HBV infection with p-value p-value was set at 5%. Results: We included 1389 prisoners out of which 97.6% were male. The median age (IQR) of the study population was 28 (23 - 35) years. The median (IQR) duration of incarceration was 12 (6 - 26) months and the mean (±sd) number of incarcerations was 1.24 (±0.6). HBV prevalence was estimated at 14.8% (95% CI: 13.0 - 16.7). Upon uni- and multivariate analysis, no risk factor was significantly associated with viral hepatitis B infection in our study population. Conclusion: The prevalence of Hepatitis B was high in the Garoua Central Prison, but there were no additional risk factors for HBV infection. There is a need to include the Garoua Central Prison and by the way other prisons in the country in the chronic viral hepatitis care program.

关键词： Hepatitis B Prison Associated factors Cameroon

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Epidemiological, Clinical Aspects and Outcome of Measles in a Low-Income Country in 2023

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Open Journal of Pediatrics 2024年第1期14卷 139-148页

作者： Sime Tchouamo Arielle Annick Enyama Dominique Noukeu Diomède Atyam Ekotto Marie Christine Abouame Palma Haoua Epee Ngoue Jeannette Kago Tague Daniel Armand Touka Eric Brice Tasse Simo Nathalie Ines Nguéfack Félicité faculty of medicine and pharmaceutical sciences of university of dschang Dschang Cameroon Gynaeco-Obstetric and Pediatric Hospital of Yaounde Yaounde Cameroon Gynaeco-Obstetric and Pediatric Hospital of Douala Douala Cameroon Regional Annex Hospital of dschang Dschang Cameroon faculty of medicine and Biomedical sciences of university of Garoua Garoua Cameroon faculty of medicine and Biomedical sciences of university of Yaounde 1 Yaounde Cameroon West Regional Delegation of Public Health Bafoussam Cameroon

Introduction: Measles remains a worrying health problem in sub-Saharan African countries. There have been measles outbreaks in Cameroon with the most recent occurring between October 2022 and September 2023. The Centre region of Cameroon was the most affected in the country and being at the frontline of the fight against this illness, we conducted this study in order to determine the epidemiological and clinical characteristics as well as the outcome of children who contracted the measles and were hospitalized at the Yaoundé Gynaeco-Obstetric and Pediatric Hospital. Methodology: We conducted a cross-sectional descriptive and prospective study for one year from October 2022 to November 2023 corresponding to the duration of the outbreak. We included all children admitted in the pediatric unit for measles and its complications during this period. Results: In total, 60 children were enrolled. Their caregivers were mostly their mothers who had a mean age of 34.71 ± 9.55 years living in significant precarious conditions for the majority. The median age of children was 16 months (09 - 30 months). Twenty six percent of children (16) were less than 9 months. Girls were predominant (55%). Most children were not up to date with their routine EPI vaccination (80%) and most did not receive the measles and Rubella vaccine (76.67%). Clinical manifestations, included fever, conjunctivitis, and cough. Skin rash and catarrh (98.33% and 86.67% respectively) are the case definition signs of measles. The outcome was unfavorable for 4 children. One had a neurological disorder: coma and three presented with pneumonia and severe respiratory distress (6.67%). Conclusion: Measles is still being a reality and claiming lives in our context, emphasis should be made on immunization coverage and if possible, advocacies should be formulated to decrease the age of measles vaccine administration.

关键词： Measles Complications Low-Income Countries

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Interleukin 6 and Bone Erosions in Rheumatoid Arthritis in an African Hospital

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Open Journal of Rheumatology and Autoimmune Diseases 2024年第1期14卷 13-19页

作者： Paul Eloundou Aly Kamissoko Fernando Kempta Francine Same Bebey William Beko’o Ange Ngeuleu William Nguekouo Estelle Megne Suzy Manizou Madeleine Singwe faculty of medicine and pharmaceutical sciences University of Douala Douala Cameroon Department of Internal medicine Cité Verte District Hospital Yaounde Cameroon Cameroon CHU Ignace Deen Conakry Guinea faculty of medicine University of Dschang Dschang Cameroon faculty of medicine and Biomedical sciences Yaoundé University of Yaoundé I Yaounde Cameroon

Introduction: Rheumatoid arthritis (RA) is a chronic, erosive and deforming inflammatory rheumatic disease. In the era of biotherapies and the arrival of biosimilars in sub-Saharan Africa, the objective of this study was to describe plasma IL-6 variations in RA patients at Cité Verte District Hospital (Cameroon). Material and Methods: Descriptive and analytical cross-sectional study from December 1, 2021 to May 31, 2022. We included patients over 18 years old suffering from RA (ACR/EULAR 2010). Patients with an infection were not included. The data collected were age, sex, smoking status, family history, disease duration, disease activity by DAS28, CRP, rheumatoid factor, and plasma level of IL-6. Bone erosion was sought on radiography and ultrasound. Result: We included 31 patients, 25 of whom were women (80.6%). The mean age was 47.27 ± 17.97 years. Disease activity was predominantly moderate (32.3%) and severe (32.3%). Mean IL-6 level was 15.29 ± 2.36 pg/ml (extremes: 11.26 pg/ml and 20.15 pg/ml). IL-6 levels were higher in patients with a history of smoking. Similarly, IL-6 levels were higher in patients with mildly active RA in remission than in moderately and severely active RA. Mean IL-6 levels were significantly higher in patients with erosive RA (16.3 pg/ml VS 14.6 pg/ml). Conclusion: IL-6 levels were significantly elevated in men, weaned smokers and patients with bone erosions.

关键词： Rheumatoid Arthritis Interleukin 6 Bone Erosion-DAS28 Sub-Saharan Africa

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Pregnancy and Obstetrical Outcomes Following Treatment for Cervical Intra-Epithelial Neoplasia (CIN) in Two Hospitals of a Low-Resource Country

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Advances in Reproductive sciences 2024年第1期12卷 51-59页

作者： Bruno Kenfack Clovis-Achille Tanekeu Atem Bethel Ajong Zabdielle Blonde Goufack Kenfack Patrick Petignat Pierre Marie Tebeu Department of Gynecology and Obstetrics Faculty of Medicine and Pharmaceutical Science University of Dschang Dschang Camer-on Institur Supérieur des sciences de la Santé Université des Montagnes Bangangté Cameroon Kekem MD District Hospital West Region Cameroon Department of Epidemiology and Public Health Faculty of Medicine and Pharmaceutical Science University of Dschang Dschang Cameron Geneva university Hospitals Genevas Switzerland faculty of medicine and Biomedical Science University of Yaounde I Yaounde Cameroon

Objective: In Cameroon, more than 80% of women suffering from cervical intraepithelial neoplasia (CIN) are within the reproductive age. This study intended to analyze the pregnancy outcomes following cervical treatment in Cameroon. Methods: This was a cohort study with two years retrospective data collection involving 82 women who underwent cervical treatment for CIN in two Cameroonian hospitals from January 2015 to December 2017. Data were collected from CIN treatment to end of pregnancy where applicable. Data analysis was done using Epi Info software version 3.5.4. Results: We collected data from 82 patients aged 27 to 48 years, with a mean age of 36.5 (SD: 5.3) years. During the study period, 33 out of 82 participants became pregnant 40.2 [29.56 - 51.66]%. The factor associated with pregnancy occurrence after treatment was age less than 35 years (Odds ratio = 4.37 [1.7 - 11.2]. From the 33 pregnancies recorded, 17 (51.5%) ended in a delivery, amongst which 15 (88.2%) were vaginal. Conclusion: Pregnancy frequency over two years following cervical treatment for CIN was relatively good, and younger women (age 35 years) were significantly more like to have conceived compared to their older counterparts. Post-treatment delivery outcomes seem to be similar to those in the general population.

关键词： Cervical Intraepithelial Neoplasia Cervical Treatment Pregnancy Outcome

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