An investigator initiated prospective single arm open-label study to evaluate effectiveness of Camylofin 50 mg and Paracetamol 325mg inpatients with acute colicky abdominal pain - ACAP Study

开始日期2024-02-10

申办/合作机构

Abbott Healthcare Pvt Ltd.

CTRI/2023/04/051566

/ Active, not recruitingN/A

Effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk: A prospective, randomized, open label, controlled, parallel study.

开始日期2023-06-23

申办/合作机构

Abbott Healthcare Pvt Ltd.

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0 项与 Abbott Healthcare Pvt Ltd. 相关的专利（医药）

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项与 Abbott Healthcare Pvt Ltd. 相关的文献（医药）

2025-12-01·TOXICOLOGY IN VITRO

Beyond traditional toxicology: The transformative power of PBTK modeling

Review

作者: Damre, Anagha ; Banerjee, Aniruddha

Physiologically Based Toxicokinetic (PBTK) modeling has emerged as a crucial tool in toxicokinetics, enabling the quantitative assessment of chemical absorption, distribution, metabolism, and excretion (ADME) across various biological systems. Unlike traditional toxicokinetic approaches, PBTK models integrate physiological and biochemical parameters to allow for precise interspecies and dose extrapolations. This capability enhances their applicability in regulatory risk assessment for pharmaceuticals, industrial chemicals, food additives, cosmetics, and pesticides. High Throughput Toxicokinetics (HTTK) and in vitro-to-in vivo extrapolations (IVIVE) further improve the predictive power of PBTK models by utilizing large-scale experimental datasets and computational approaches. Additionally, these models facilitate route-to-route extrapolations, predicting systemic exposure across different administration routes such as oral, inhalation, and dermal pathways. PBTK modeling also enables the estimation of specific target tissue concentrations, cross-species extrapolations, and extrapolations to special populations, thereby improving human biological modeling. Furthermore, the integration of PBTK models in ecological risk assessment supports the evaluation of environmental chemical exposure effects on diverse species. As regulatory agencies increasingly adopt PBTK models for toxicity evaluations, their role in advancing data-driven risk assessment and reducing reliance on animal testing continues to grow. This review explores the application of PBTK modeling in toxicokinetics and its alignment with regulatory guidelines for risk assessment and interspecies extrapolation.

2024-11-01·Indian Heart Journal

Morphological characterization of coronary plaques in young indian patients with acute coronary syndrome: A multicentric study

Article

作者: Vijayvergiya, Rajesh ; Mathew, Rony ; Priyadarshini ; Sethi, Rishi ; Goel, P K ; Baruah, D K ; Roy, Sanjeeb ; Chouhan, Nagendra Singh ; Kaul, Upendra ; Narang, Manish

OBJECTIVES:

The prevalence of atherosclerosis and acute coronary syndrome (ACS) is increasing in young Indians (18-50 years of age). However, the characteristics of atherosclerotic plaques in such individuals are poorly understood, presenting distinct challenges for the management of ACS. This study aims to analyze plaque characteristics in young Indian patients with ACS who underwent percutaneous coronary intervention (PCI) using optical coherence tomography (OCT) imaging.

METHODS:

This was a prospective, multicentric, non-interventional study on patients aged 18-50 years presenting with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction, or unstable angina, and were scheduled to undergo OCT-guided PCI. Major adverse cardiac events (MACE) were assessed post-procedure and at the 6-month and 12-month follow-ups.

RESULTS:

The study included 100 ACS patients (mean age = 43.6 ± 5.2 years), with 51% presenting with STEMI. Pre-PCI OCT assessment showed that fibrous plaques (75%) were most common followed by plaques containing macrophages (27%), microchannels (20%), and calcified nodules (14%). In addition, plaque rupture, plaque erosion, and lipid-rich plaques, along with red, white, and mixed thrombi, were observed in 31%, 25%, 24%, 21%, 14%, and 17% (total thrombus occurrence = 52%) of the patients, respectively. At 12 months, the MACE (coronary artery bypass graft) rate was 1%.

CONCLUSIONS:

Young Indian patients with ACS displayed a range of plaque morphologies identified through pre-PCI OCT. Among these, fibrous plaques were the most prominent type, followed by plaques containing macrophages. Additionally, plaque rupture, plaque erosion, and lipid-rich plaques were also observed in this population.

2024-09-01·Indian journal of endocrinology and metabolism

Association Between Type 2 Diabetes and Hypogonadism in India: An Observational Study

Article

作者: Saraogi, Ravi K. ; Dutta, Deep ; Bhattacharya, Arpan D. ; Basu, Indraneel ; Gawand, Kalpesh ; Ramakrishnan, Anantharaman ; Unnikrishnan, Ambika G. ; Mahadevan, Shriraam ; Bharathi, Prakadeesh ; Sundar, Shanmuga ; Majumdar, Anirban ; Saboo, Banshi D.

Abstract:

Introduction::

Hypogonadism is a common comorbidity associated with several metabolic disorders including type 2 diabetes (T2D) that can remain undetected without proper screening. Here, we evaluated the prevalence of hypogonadism in Indian male patients with T2D with or without obesity.

Methods::

In this prospective, observational study, male patients with T2D and hypogonadism were evaluated symptomatically using the androgen deficiency in ageing male (ADAM) questionnaire at baseline and confirmed on the basis of total testosterone (TT) levels (<300 ng/dL) at Days 5–7 (Visit 2) and 9–14 (Visit 4) assessed after 12 hours of fasting between 8 AM and 10 AM. Prevalence of hypogonadism was presented as proportion of patients.

Results::

Of 598 enrolled patients, 526 completed the study. Mean (standard deviation [SD]) age was 50.4 (9.12) years. The percentage of patients with TT <300 ng/dL at visit 2 was 18.4%, while upon repeat confirmation, it reduced to 8.6%. Thus, the prevalence of true hypogonadism was 8.6%. Prevalence of hypogonadism in patients with BMI range of >30 kg/m2 (obese) was 11.1%. At screening, 81.4% (487 of 598) patients had positive ADAM questionnaire results.

Conclusions::

Prevalence of hypogonadism in Indian patients with T2D was found to be 8.6% upon repeat evaluation of testosterone. Symptomatic (ADAM questionnaire) as well as biochemical (total testosterone levels with repeat evaluation) confirmation is vital in the definite diagnosis of male hypogonadism.

项与 Abbott Healthcare Pvt Ltd. 相关的新闻（医药）

2021-08-25

·Pharmaindustrial

NPPA releases draft version of retail price proposals for 11 drugs

The National Pharmaceutical Pricing Authority (NPPA) has released the draft version of the proposed price calculation sheet for retail price of 11 medicines from various players in the country. The price fixation include paracetamol IP 1000 mg, which has the highest moving annual total (MAT) of Rs. 269.2 crore, to levetiracetam IP 500 mg plus sodium chloride IP 820 mg combination with a MAT of Rs 3.76 lakh. The paracetamol tablet retail prices for Aishwarya Healthcare (manufacturer) and FDC Ltd (marketer) have been proposed at Rs. 254.81 per pack including retailer margin and excluding GST. This is against the highest price of Rs. 335.91 for Malidens 1000 mg infusion 100 ml from Abbott Healthcare Pvt Ltd and Rs 77 per pack for Dolo 1000 MG infusion 100 ML, from Micro Labs Ltd. There are 38 companies selling the same medicine in this category, the whole 11 consists of a market share of one per cent or above. The levetiracetam IP 500 mg plus sodium chloride IP 820 mg for Akums Drugs and Pharmaceuticals Ltd (manufacturer/importer) and Linux Laboratories Pvt Ltd (marketers), has been proposed with a retail price of Rs. 91.56 per unit, with the only player in the market has Rs. 78.93 per Unit fixed, for Levera RTU from Intas Pharmaceuticals Ltd. The amount includes the average price of Rs. 78.93 per unit, along with 16 per cent retailer margin. The other formulations for which the retail price has been proposed include methotrexate topical gel from Alaina Healthcare Pvt Ltd (manufacturer) and IPCA Laboratories Ltd (marketer), 100 ml of levetiracetam in 0.82 per cent sodium chloride injection, intravenous infusion for Sun Pharma, various strengths of chlorthalidone IP plus amlodipine besylate IP from Akums Drugs and Pharmaceuticals (manufacturer) and Dr Reddy’s Laboratories Ltd (marketer), and different strengths of metoprolol succinate IP of Pure and Cure Healthcare Pvt Ltd (manufacturer) and Lupin Ltd (marketer).