Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations.

The U.S. Food and Drug Administration (FDA) has defined narrow therapeutic index (NTI) drugs as "those drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity.

Estimation of radon concentration in groundwater in the mining zone of Haryana, India, for lungs and stomach annual effective dose.

The groundwater is being used for drinking and irrigation purposes in vast swathes of the Aravalli Mountain range. Since the radioisotope presence in groundwater is affected by the local mining processes, the radiation monitoring in groundwater of mining regions is of paramount importance. In the present work, we have estimated the 222Rn presence in the mining region of Aravalli in the southern part of Haryana.

Choices and Challenges With Treatment of Myasthenia Gravis in Pregnancy: A Systematic Review.

Myasthenia gravis (MG) is an autoimmune disease affecting young women in their second and third decades, coinciding with their reproductive years. We aim to explore the choices and challenges in the treatment of MG in pregnancy. Cochrane, PubMed, Google Scholar, and Embase were the four databases systematically searched for studies with patients reporting pregnancy outcomes for women with MG during pregnancy using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) technique.

Male breast cancer: a 30 year retrospective analysis from a tertiary cancer care centre.

Background: Male breast cancer (MBC) is one of the rare malignancies that account for less than 1% of all malignancies in males. However, the clinicopathological characteristics of MBC are not entirely similar to female breast cancer; but still, it is treated in line with the female breast cancer protocols.

Aims: To retrospectively analyse trends in MBC as to its distribution, presentation, treatment, and outcome.

In Vitro Modulation of Genotoxicity and Oxidative Stress by Polyphenol-Rich Fraction of Chinese Ladder Brake (Pteris vittata L.).

Pteris vittata L. is a terrestrial genus growing in moist, shady forests and on hillsides. The plant has considerable ethnomedicinal importance.

Pretreament neutrophil-lymphocyte ratio (NLR): A felicitous prognostic marker in carcinoma lung.

Background: Mechanics of inflammation and oncogenesis are intertwined with each other. Thus, the role of inflammatory markers like neutrophil-lymphocyte ratio (NLR) as a foreteller of lung carcinoma is retrospectively appraised in this study.

Material And Methods: Retrospective assessment of hospital records of carcinoma lung patients was done between January 2018 and January 2020 and pretreatment NLR was calculated.

Homeopathic Medicines in Second Wave of COVID-19: Prognostic Factor Research.

Background: The clinical profile and course of COVID-19 evolved perilously in a second wave, leading to the use of various treatment modalities that included homeopathy. This prognostic factor research (PFR) study aimed to identify clinically useful homeopathic medicines in this second wave.

Methods: This was a retrospective, multi-centred observational study performed from March 2021 to May 2021 on confirmed COVID-19 cases who were either in home isolation or at COVID Care Centres in Delhi, India.

Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products.

The US FDA's rule on "Requirements for Submission of Bioequivalence Data" requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we evaluated the impact of data from non-pivotal BE studies in assessing BE and identified the reasons for failed in vivo BE studies for generic oral delayed-release (DR) drug products only. We searched the Agency databases from January 2009 toDecember 2016 to identify Abbreviated New Drug Applications (ANDAs) submitted for DR drug products containing non-pivotal BE studies.

Hepatoprotective activity of Butea monosperma bark against thioacetamide-induced liver injury in rats.

For thousands of years, the plant-based natural products have been a source of curative agents for various ailments. Butea monosperma (Fabaceae) has an important place in Indian traditional system of medicine for curing number of disorders. The present study deals with evaluation of hepatoprotective properties of ethyl acetate fraction (Beac) from B.

Inhibitory Activities of Butanol Fraction from Butea monosperma (Lam.) Taub. Bark Against Free Radicals, Genotoxins and Cancer Cells.

The present study was undertaken to investigate antioxidant, antigenotoxic, and antiproliferative activity of butanol fraction (Bmbu) from bark of medicinal plant Butea monosperma. Antioxidant potency of Bmbu was examined by various in vitro assays. It was also investigated for antigenotoxic activity using Escherichia coli.

Ethyl acetate fraction of Pteris vittata L. alleviates 2-acetylaminofluorene induced hepatic alterations in male Wistar rats.

Pteris vittata L. commonly called 'Brake Fern' possesses some interesting medicinal properties but its chemopreventive potential largely remains unexplored. Therefore, this study was designed to explore the chemopreventive efficacy of P.

Antioxidant and hepatoprotective potential of Lawsonia inermis L. leaves against 2-acetylaminofluorene induced hepatic damage in male Wistar rats.

Background: Lawsonia inermis (Lythraceae) is an ethnomedicinal plant, traditionally known for curing several ailments such as skin diseases, bacterial infections, jaundice, renal lithiases and inflammation etc. The present work deals with assessment of in vitro antioxidant and in vivo hepatoprotective potential of butanolic fraction (But-LI) of Lawsonia inermis L. leaves.

Modulatory effects of Cassia fistula fruits against free radicals and genotoxicity of mutagens.

Cassia fistula L. (Fabaceae) fruits are highly recommended in folklore medicine for curing various ailments. In the current study, methanol (CaFM), hexane (CaFH), chloroform (CaFCl), ethyl acetate (CaFE), butanol (CaFB) and aqueous (CaFA) fractions of C.

A Retrospective Evaluation of Clinical Profile of Second Primary Head and Neck Cancer.

Introduction: Incidence of Second Primary Malignancy (SPM) after successful treatment of primary is increasing and may cause the problem for optimal treatment.

Aim: This study was conducted retrospectively to analyse incidence, disease free survival between malignancies, pattern of treatment and outcome.

Materials And Methods: Sixteen out of 22 patients of previously treated cases of head and neck cancer those develop SPM of head and neck region managed over a period of January 2012 to December 2015 in Department of Radiotherapy-II, Pt.

Exploring the Management of Radiation Proctitis in Current Clinical Practice.

Introduction: Radiation proctitis is radiation induced rectal mucositis, occurring as a consequence to radiation therapy of the pelvic organs for various pelvic region malignancies. The management of radiation proctitis is extremely challenging as no recommended guidelines are available and limited number of studies are there in the literature involving the various treatment options.

Aim: The aim of the study is the in-depth review of published literature to see the role of various treatment modalities in the management of radiation proctitis.

Central myofibroma of the maxilla.

Myofibroma is a rare benign localized or generalized proliferation of myofibroblastic tissue occurring mostly in infants or children. In the oral region, most lesions occur in the mandible, lip, buccal mucosa, and tongue; however, the lesions arising in the maxilla are very rare. Myofibroma has an aggressive clinical presentation and is often treated aggressively because of an inappropriate diagnosis.

What are we drinking? Assessment of water quality in an urban city of Punjab, India.

Introduction: Ground water is the ultimate and most suitable fresh water resource for human consumption in the urban areas of India. Studies regarding ground water quality have shown that the higher rate of exploration as compared to the rate of recharging, inappropriate dumping of solid, as well as liquid waste, lack of strict enforcement of law has led to the deterioration of ground water quality. The present study was thus, carried out to evaluate physicochemical, as well as a microbiological profile of tap water, and filtered water in urban areas of Patiala, Punjab.

Chemical composition and inhibitory effects of water extract of Henna leaves on reactive oxygen species, DNA scission and proliferation of cancer cells.

From the centuries, L. (Henna) is utilized in traditional health care system as a medicinal and cosmetic agent. The present study was intended to assess antiradical, DNA protective and antiproliferative activity of water extract of L.

Dermatofibrosarcoma Protuberans of Lumbar Region with Metastasis to Lung: A Rare Presentation.

Dermatofibrosarcoma protuberans (DFSP) is a cutaneous slow growing soft tissue sarcoma associated with a high local recurrence rate. Common site of presentation is trunk followed by proximal extremity and head and neck region. A case of recurrent DFSP of left lumbar region with metastasis in lung in a 50-year-old woman presented here.

Primary Non Hodgkin's Lymphoma of Left Adrenal Gland - A Rare Presentation.

Primary adrenal lymphoma is rare and constitutes for 3% of extranodal lymphoma cases. Approximately 70% of patients present with bilateral disease and have adrenal insufficiency. Prognosis of primary adrenal lymphoma (PAL) is poor, most of patient die within one year of diagnosis.

A rare presentation of primary leiomyosarcoma of ovary in a young woman.

Primary ovarian leiomyosarcoma is a very rare tumour which is most commonly seen in postmenopausal women. A case is described here involving a 30-year-old female who presented with pain in the abdomen. The patient underwent laparotomy with peritoneal lavage, bilateral salpingo-oophorectomy, and total abdominal hysterectomy.

Antiproliferative and Apoptosis Inducing Effects of Non-Polar Fractions from Lawsonia inermis L. in Cervical (HeLa) Cancer Cells.

Two non-polar fractions viz. hexane (Hex-LI) and chloroform fraction (CHCl3-LI) of Lawsonia inermis were studied for their antiproliferative potential in various cancer cell lines viz. HeLa, MCF-7, A549 and C6 glioma cells.

Applications of In Vitro-In Vivo Correlations in Generic Drug Development: Case Studies.

In vitro-in vivo correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property and a relevant in vivo response. The main objective of an IVIVC is to serve as a surrogate for human bioequivalence (BE) studies, which may reduce the number of BE studies performed during the initial approval process as well as with certain scale-up and postapproval changes. The US Food and Drug Administration (FDA) published a regulatory guidance related to development, evaluation, and applications of IVIVC for extended-release (ER) oral dosage forms in September 1997.