Single high-dose amphotericin B for cryptococcal meningitis: First Indian experience.

Cryptococcus is a common organism causing central nervous system disease in people living with HIV (PLHIV). The treatment of this infection entails a costly regimen of Amphotericin. World Health Organization (WHO) recently recommended a cost-effective single high-dose regimen with liposomal amphotericin B for the treatment of cryptococcal meningitis.

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions.

Pharmaceutical innovators and generic companies use Physiologically Based Biopharmaceutics Models (PBBMs) to guide drug product development and potentially waive clinical pharmacokinetic studies for both pre- and postapproval changes. This modeling approach can assist with biopharmaceutics risk assessment and the establishment of patient centric, clinically relevant drug product specifications. However, the variability of possible model strategies and the existence of gaps in scientific knowledge associated with the lack of standardized regulatory expectations for model parametrization, data requirements for model development, and criteria for fit-for-purpose model validation leads to varied acceptance rates and frequent requests for additional information and deficiencies in PBBM submissions across regulatory agencies.

Virological Failure And HIV-1 Drug Resistance in Indian Adults and Adolescents on Protease Inhibitor Based Second-line Antiretroviral Therapy: A Five-year Follow-up Study.

Introduction: In the changing HIV treatment landscape, the focus shifts to persons living with HIV (PLH) experiencing virological non-suppression on second-line antiretroviral therapy (ART). This includes understanding viral genetic profiles, antiretroviral susceptibility, and the effectiveness of protease inhibitors (PIs) amid evolving dolutegravir-based regimen recommendations.

Methods: In this retrospective study, PLH with first-line ART failure transitioned to second-line ART (dual NRTI + ritonavir-boosted PI) between September 2015 and October 2018.

Unusual Presentation of Metachronous Multicentric Giant Cell Tumor of Forearm Bones with Literature Review.

Case: We present an unusual case of metachronous multicentric giant cell tumor (GCT) of forearm bones in a 38-year-old male patient with an 8-year follow-up. The diagnosis was established by imaging and histopathology. He underwent multiple surgeries with extraperiosteal resection of lesions with free fibular grafts.

Impact of polysaccharide addition on the technological aspects of low lactose milk powders.

The research aimed to assess the effect of polysaccharides (maltodextrin and β-cyclodextrin) on technological properties of low-lactose milk powder obtained by spray drying of β-galactosidase hydrolysed milk. Low-lactose milk powders i.e.

"Does advanced imaging improve the reliability of 2018 AO/OTA classification for trochanteric femoral fractures?".

Background: The influence of advanced imaging modalities on the reliability of 2018 AO/OTA classification and detection of features contributing to fracture instability have not been adequately studied in the literature.

Methods: This prospective study was conducted to assess the reliability of 2018 AO/OTA classification for trochanteric femoral fractures, and features of instability in 50 patients using radiographs, multiplanar reformats (MPR), and 3D-reconstruction with fracture segmentation (3DR-FS) by 3 observers on 2 occasions at an interval of 4 weeks.

Results: Mean inter-observer reliabilities on radiographs, MPR, 3DR-FS were 0.

Isolated Tuberculous Osteomyelitis of Calcaneus in an Immune-Competent Adult Patient With Literature Review: A Case Report.

Case: We present a case of isolated tuberculous osteomyelitis of the calcaneus in an immune-competent adult patient with a 5-year follow-up. The diagnosis was established by core needle aspiration and biopsy. He was treated with antituberculous chemotherapy and immobilization.

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.

This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the regulatory agencies perspectives. The presentations, which included several case studies, covered the applications of PBBM in generic drug product development, applications of virtual bioequivalence trials to support formulation bridging and the utility of absorption modeling in clinical pharmacology assessments.

Shortening Dome Osteotomy for the Correction of Coronal Plane Elbow Deformities.

Background: Severe elbow deformities are common in developing countries because of neglect or as a result of prior treatment that achieved poor reduction. Various osteotomy techniques have been defined for the surgical correction of elbow deformities. However, severe elbow deformities (>30°) pose a substantial challenge for surgeons because limited surgical options with high complication rates have been described in the literature.

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.

The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM case studies from six regulatory authorities which provided considerations for model verification, validation, and application based on the context of use (COU) of the model. PBBM case studies to define critical material attribute (CMA) specification settings, such as active pharmaceutical ingredient (API) particle size distributions (PSDs) were shared.

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented their views on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification.

Reduction of maillard browning in spray dried low-lactose milk powders due to protein polysaccharide interactions.

Lactose hydrolysed concentrated milk was prepared using β-galactosidase enzyme (4.76U/mL) with a reaction period of 12 h at 4 °C. Addition of polysaccharides (5 % maltodextrin/β-cyclodextrin) to concentrated milk either before or after lactose hydrolysis did not result in significant differences (p > 0.

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application.

Development of a thin layer chromatography-based method to detect sorbitol presence in milk and its applicability in formalin preserved milk samples.

Sorbitol has been the new and emerging adulterant in dairy industry. The main aim of the study was to develop a method to detect sorbitol in milk, which is not affected by other sugars, polyols and formalin. Hence, a thin layer chromatographic (TLC) method was standardized to detect the sorbitol in milk.

Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application.

Aims: The current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations.

Methods: Vaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic concentrations of 5 different compounds, namely, dapivirine, tenofovir, lidocaine, ethinylestradiol and etonogestrel, administered as vaginal ring or gel.

Wedgeless V-Shaped Osteotomy of the Distal Medial Femur with Locking Plate Fixation for Correction of Genu Valgum in Adolescents and Young Adults.

Background: Genu valgum is a common disorder affecting adolescents and young adults. Treatment of this disorder requires restoration of normal mechanical axis alignment and joint orientation, for which it is important to assess whether the deformity arises from the distal femur, knee joint, or proximal tibia. Most commonly, the deformity originates from the distal femur, and various osteotomies of the distal femur have been described.

A Phase-IV Non-interventional Study to Assess Virological Effectiveness, Safety, and Tolerability of DTG-based Antiretroviral Therapy in HIV-1 Infected Indian Persons Living with HIV.

Background: Dolutegravir (DTG) is a novel yet preferential first- and -second-line treatment for persons living with HIV (PLH). Owing to its recent introduction, DTG-based regimens have not undergone a comprehensive, systematic evaluation regarding their real-world utilization and safety profile among a sizeable Indian population.

Objective: This study aimed to assess the 24 week immunovirological outcomes, anthropometric and metabolic changes, tolerability, and adverse events (AEs) of DTG-based antiretroviral (ART) regimens.

Development and application of DPPH impregnated paper based color sensor disc to detect vegetable oils addition in cow ghee.

Ghee is a premium product in Southeast Asia and is prone to adulteration with vegetable oils/ fats. The main aim of the study was to develop an easy-to-use paper-based sensor to detect this adulteration. Hence, a protocol involving hexane and acetonitrile for the extraction of synthetic antioxidants from adulterated ghee and its rapid detection using DPPH was standardized.

Valorization of Sour Buttermilk (A Potential Waste Stream): Conversion to Powder Employing Reverse Osmosis and Spray Drying.

Reverse osmosis (RO) is known for the economic dewatering of dairy streams without any change in phase. At the household level, surplus milk is fermented and churned to obtain butter, which is subsequently heated to obtain clarified milk fat (). The production of 1 kg generates 15-20 kg sour buttermilk (SBM) as a by-product that is mostly drained.

Acquired Hallux Varus Deformity Correction: Pivotless Distraction Technique.

Acquired hallux varus deformity secondary to postburn contracture is a rare condition. It causes cosmetic disfigurement, pain, and inability to wear a shoe. Soft-tissue procedures and tendon transfers have been described for correction; however, these may require multiple operations and the outcome may be poor.