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04053 Ranbaxy递交齐多夫定的ANDA以支持PEPFAR
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作者 杨绍杰 《国外药讯》 2005年第4期23-23,共1页
Ranbaxy公司已经向美国FDA递交了齐多夫定(zidovudine)片剂(300mg)(Ⅰ)的ANDA。这是公司首个递交的抗逆转录病毒药的ANDA申请,以支持美国总统AIDS救助紧急计划(PEPFAR)的行动。如果相互可接受获得条款被同意的话,一旦获得FDA的批准,R... Ranbaxy公司已经向美国FDA递交了齐多夫定(zidovudine)片剂(300mg)(Ⅰ)的ANDA。这是公司首个递交的抗逆转录病毒药的ANDA申请,以支持美国总统AIDS救助紧急计划(PEPFAR)的行动。如果相互可接受获得条款被同意的话,一旦获得FDA的批准,Ranbaxy公司的通用名产品可在确认PEPFAR的国家用于艾滋病患者的治疗。早些时候美国声称FDA将使对联合包装和固定剂量的复合HIV/艾滋病药物的审查更加合理化,PEPFAR将付费给那些被批准的药物。 展开更多
关键词 Ranbaxy公司 齐多夫定 ANDA pepfar 抗逆转录病毒药
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Baseline Laboratory Profile of HIV Positive Patients on Antiretroviral Therapy in Jos North Central Nigeria: Implications for Pre-vention, Treatment, Care and Support
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作者 Christian Ogoegbunem Isichei Mercy Wakili Isichei +11 位作者 Jean Emile Njab Johnson Ibidun Rotimi Tinuade Abimbola Oyebode Charles Ujunwa Anyaka Kenneth Emeka Enwerem Ayuba Ishiaku Affi Lucius Chidiebere Imoh Alexander Ogielu Abu Solomon Abiola Asorose Noel Omuya Amadu Propser Ihenacho Okonkwo Ngozi Ijeoma Okoro 《World Journal of AIDS》 2015年第4期328-334,共7页
Background: We characterized baseline laboratory data of patients to identify priority treatment areas, most affected populations, anticipated clinical complications and assessed the potential burden of retention in c... Background: We characterized baseline laboratory data of patients to identify priority treatment areas, most affected populations, anticipated clinical complications and assessed the potential burden of retention in care in Jos, Plateau State—North Central Nigeria. Methods: This study was a cross-sectional design from January 2004 to December 2005 at Faith Alive Foundation (FAF). All participants were HIV-positive and underwent pre-antiretroviral therapy counseling based on the national antiretroviral therapy (ART) guidelines and baseline laboratory testing. Data were captured on Microsoft Excel, validated on Epi Info and analyzed on SPSS version 21 at P < .05 level of significance. Results: Total of 1499 (463 men and 1036 women) participants were evaluated in this study. The age and sex related distribution of participants showed that majority (80.3% for males and 92.5% for females) were 16 - 45 years old. Amylase and creatinine were significantly higher in males than females (P = .02). Anaemia was the most common baseline abnormality (63% for females and 58% for males), while baseline CD4 count was significantly lower in males than females (P < .02) and at one-third had elevated liver enzymes (AST and ALT). Conclusion: The baseline laboratory profile of most HIV positive patients in Jos and environs of North Central–Nigeria was characterized by anaemia, elevated creatinine, and abnormal liver transaminase levels (AST and ALT). This pre-ART laboratory result suggests that HIV-positive individuals have multiple clinical abnormalities which may require more extensive care than just treating the HIV disease. 展开更多
关键词 BASELINE LABORATORY PROFILE HIV-Positive PATIENTS pepfar HTC NIGERIA
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