Cancer immunotherapy's renaissance

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Using GFR, Albuminuria, and Their Changes in Clinical Trials and Clinical Care

The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint.

Penjangkitan wabah Avian influenza menjadi persoalan kesehatan yang menimbulkan dampak serius di bidang yang lain, seperti ekonomi, sosial-budaya, politik, pertahanan, dan keamanan, baik di tingkat nasional maupun internasional, termasuk di Indonesia. Berbagai upaya telah dilakukan untuk mengantisipasi penyebaran wabah ini, salah satunya dengan tindakan karantina untuk menghambat penyakit tersebut dengan tetap mempertimbangkan kelancaran perjalanan, yang dilakukan di area pintu masuk, antara lain di bandar udara, pelabuhan laut, stasiun angkutan darat, sebagai tempat perbatasan antara suatu wilayah dan wilayah luar. Karena itu, tujuan penelitian ini adalah untuk mengetahui peran karantina sebagai alat pencegah untuk menghalangi penjangkitan Avian influenza dan efektivitas implementasinya di Bandara Internasional Soekarho-Hatta. Penelitian ini menggunakan metode deskriptif kualitatif. Lokasi penelitian ini adalah Kantor Kesehatan Pelabuhan (KKP) Kelas I Jakarta Bandara Soekarno Hatta. Data yang digunakan adalah data primer yang diperoleh melalui observasi dan wawancara dan data sekunder yang diperoleh lewat studi dokumenter. Data yang terkumpul dianalisis dengan teknik deskriptif kualitatif. Hasil penelitian ini menunjukkan bahwa di Indonesia, kegiatan karantina diterapkan terutama di Kantor Kesehatan Pelabuhan Kelas I Jakarta dengan tugas dan fungsi pokok mencegah masuknya penyakit karantina dan penyakit menular berpotensi wabah. Sementara itu, di Kantor Kesehatan Pelabuhan Kelas I Bandara Soekarno-Hatta, tugas dan fungsi pokoknya adalah melaksanakan karantina pada pintu masuk wilayah negara Republik Indonesia. Pelaksanaan tugas dan fungsi itu dipengaruhi oleh beberapa faktor antara lain: dasar legalitas (landasan hukum dan operasional) organisasi, sarana dan prasarana, sumber daya manusia, Standar Operasional Prosedur, Kerjasama Lintas-Sektor dalam penerapan teknologi informasi serta dukungan dana untuk pembiayaan operasional kegiatan. Efektivitas berbagai upaya tersebut sangat diperlukan untuk mendukung kokohnya ketahanan nasional dalam upaya penyempurnaan kegiatan karantina yang dilaksanakan KKP Kelas I Bandara Soekarno-Hatta. Pertama, revisi UU No. 2/1962 tentang Karantina perlu dilakukan agar lebih disesuaikan dengan Peraturan Kesehatan Internasional 2005. Kedua, pembenahan sarana dan prasarana perlu dilakukan untuk mendukung pelaksanaan pengawasan higienitas dan sanitasi pesawat sebagai alat angkut, pelayanan kesehatan berupa perbaikan sarana observasi penderita, laboratorium maupun kegiatan rujukan penderita. Ketiga, pengembangan sumber daya manusia, rekrutmen tenaga operasional sesuai dengan tugas melalui pendidikan dan pelatihan. Keempat, penyempurnaan Standar Operasional Prosedur, yang sesuai dengan karakteristik penyakit, dengan tetap mempertimbangkan kelancaran pelaku perjalanan. Kelima, mempermantap kerjasama lintas-sektor antar- dan inter-lembaga serta jaringan informasi pihak banda dan di luar negeri. Dan keenam, mengoptimalkan ketersediaan dana dalam upaya mendukung kegiatan karantina dengan menggali sumber dana dari pihak yang terkait. The outbreak of Avian influenza epidemics is a health problem resulting in serious impact in economic, socio-cultural, political, defence and security sectors at the national and international levels, including in Indonesia. Various efforts are done to anticipate the epidemic, one of which is to do the quarantine efforts of impeding its dissemination while considering smooth traveling in gateways, such as in airport, seaport and land transport station as main borders between territory and the outside. Therefore, purpose of this study is to find out the role of quarantine as the preventive instrument of inhibiting the outbreak of Avian influenza and its effectiveness of implementation in Soekarno-Hatta International Airport. The study used a descriptive qualitative method. The location of the study was the Airport Health Office of Class I Jakarta. Data used were both primary data obtained from interview and secondary data obtained through documentary study. Data collected were then analyzed by a descriptive qualitative technique. Result of the study indicates that the quarantine efforts in Indonesia were particularly done in Airport Health Officer of Class I (AHO-I) Jakarta with main task and function of inhibiting the dissemination of quarantined diseases and potential infectious disease epidemics. In AHO-I of Soekarno-Hatta International Airport, the main task and function was to do quarantine activity in gateways of the Republic of Indonesia. The performance of main tasks and functions were influenced by several factors, such as regulation, infrastructure, human resource, Standard Operating Procedures, cross-sector cooperation in the application of information technology, and fund to support operational finance. The effectiveness of various efforts is highly required to support the national security of completing the quarantine programs in AHO-I of Soekarno-Hatta International Airport. First, revision of Act No. 2/1962 on Quarantine should be done in order to be adapted to International Health Regulation of 2005. Second, the improvement of infrastructures is necessary to do for supporting the performance of hygienist and sanitation monitoring of plane as transport facility, health services by improving patient observation facility, laboratory, and patient reference guides. Third, human resource development and operational personnel recruitment appropriate with main tasks by education and training. Four, completing the Standard Operating Procedures adapted to the characteristics of disease while considering smooth traveling. Five, the establishment of intra- and inter-institutional cross-sector cooperation and the information networks of domestic and foreign airports. And six, optimizing fund sufficiency in the efforts of supporting the quarantine activity by exploring the source of fund from related parties.

The US Food and Drug Administration approval process for psychotropic drugs requires safety studies of carcinogenicity in animals. These studies are consistently conducted and provide a database for assessment of potential biological risk of carcinogenicity in humans. This report is a systematic review of that database for psychotropic drugs. US Food and Drug Administration-approved registration data ('package inserts') were examined, where available, for all psychotropic drugs in the following classes: antidepressants, antipsychotics, benzodiazepines/sedative-hypnotics, amphetamines and anticonvulsants. Overall, new generation (atypical) antipsychotics (90%, 9/10 agents) and anticonvulsants (85.7%, 6/7 agents) showed the highest evidence of carcinogenicity among psychotropic drugs classes assessed. Antidepressants (63.6%, 7/11) and benzodiazepines/sedative-hypnotics (70%, 7/10) were next, and stimulants (with the exception of methylphenidate) were last (25%, 1/4 agents). Overall, 71.4% of all drugs examined (30/42) showed evidence of carcinogenicity in 43.2% (38/88) of specific experimental studies. US Food and Drug Administration-based analyses demonstrate that almost all atypical antipsychotics and anticonvulsants are carcinogenic in animals, as are the majority of antidepressants and benzodiazepines and methylphenidate. These animal-based results are not sufficient to draw definitive conclusions in humans, but they provide data that could be acknowledged in the informed consent process of clinical treatment.

Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

Rapid Test for Antibodies to Hepatitis C Virus Approved by the US Food and Drug Administration

Drug-drug interaction (DDI) data for small molecular drugs approved by the US Food and Drug Administration in 2020 (N = 40) were analyzed using the University of Washington Drug Interaction Database. The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application reviews. About 180 positive clinical studies defined as mean area under the curve ratios (AUCRs) ≥1.25 for inhibition DDIs or pharmacogenetic studies and ≤0.8 for induction DDIs were then fully analyzed. Oncology was the most represented therapeutic area, including 30% of 2020 approvals. As victim drugs, inhibition and induction of CYP3A explained most of all observed clinical interactions. Three sensitive substrates were identified: avapritinib (CYP3A), lonafarnib (CYP3A), and relugolix (P-glycoprotein), with AUCRs of 7.00, 5.07, and 6.25 when coadministered with itraconazole, ketoconazole, and erythromycin, respectively. As precipitants, three drugs were considered strong inhibitors of enzymes (AUCR ≥ 5): cedazuridine for cytidine deaminase and lonafarnib and tucatinib for CYP3A. No drug showed strong inhibition of transporters. No strong inducer of enzymes or transporters was identified. As expected, all DDIs with AUCRs ≥5 or ≤0.2 and almost all those with AUCRs of 2-5 and 0.2-0.5 triggered dosing recommendations in the drug label. Overall, all 2020 drugs found to be either sensitive substrates or strong inhibitors of enzymes or transporters were oncology treatments, underscoring the need for effective DDI management strategies in patients with cancer often receiving polytherapy. SIGNIFICANCE STATEMENT: This minireview provides a thorough and specific overview of the most significant pharmacokinetic-based DDI data observed (or expected) with small molecular drugs approved by the US Food and Drug Administration in 2020. It will help to better understand mitigation strategies to manage the DDI risks in the clinic.

Prescription patterns of long-acting β-agonist monotherapy for patients with asthma

Protecting profits

Clinical Prioritization of Antispike Monoclonal Antibody Treatment of Mild to Moderate COVID-19

Safety Versus Tolerability

Trials and tribulations of antibiotic development

BackgroundDrug‐induced myocarditis has emerged as an increasingly significant concern with both established and novel medications. This study aimed to identify temporal trends and high‐risk populations in drug‐induced myocarditis through cross‐regulatory pharmacovigilance analysis.MethodsData from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases were analyzed from 2004 to 2023. Drugs associated with myocarditis were identified and classified by therapeutic class, with trends evaluated using linear regression, stratified by age and sex.ResultsDrug‐induced myocarditis was reported in 9983 cases in the US Food and Drug Administration Adverse Event Reporting System (increasing from 114 to 1819) and 3718 cases in the Japanese Adverse Drug Event Report database (rising from 18 to 655) from 2004 to 2023. Monoclonal antibodies and antipsychotics were the fastest‐growing risk categories, a trend led by monoclonal antibodies in the US Food and Drug Administration Adverse Event Reporting System (+26.82 cases/year) and corroborated in the Japanese Adverse Drug Event Report database (+13.88 cases per year). Clozapine was the most frequently reported single drug in the US Food and Drug Administration Adverse Event Reporting System (12.79% of all cases, +6.96 cases per year). These trends showed consistent patterns across population subgroups; age‐stratified analysis revealed that the increase in monoclonal antibodies was concentrated in the older group, whereas the trend for antipsychotics was most prominent in adults. Gender‐specific analysis showed that trends for monoclonal antibodies and antipsychotics were more pronounced in men, whereas chemotherapy agents increased more in women.ConclusionsIntegrated analysis of multinational pharmacovigilance data enhances real‐time risk detection and underscores the need for precision surveillance strategies targeting high‐risk therapies and vulnerable populations.