Journal of Pharma and Drug Regulatory Affairs (e-ISSN:2582-3043)

Aspects of Regulation Concerning the New Drug Approval Procedure in the USA

2024-03-16T07:53:40+00:00

Pharmaceutical technologists, pharmacologists, and medicinal chemists all contribute significantly to science during the drug-development process. The drug approval process involves several steps, including discovery, pre-clinical testing, clinical testing, investigative new drug application filing, and new drug application filing. Before authorized drugs are put on the market in the USA, the US FDA is the regulatory body that assesses their efficacy and safety. Drug reviewers work for regulatory bodies all over the world, and it is their job to determine whether the study results support a new drug product's quality control, safety, and efficacy in serving public health. This article describes how innovative pharmaceuticals are discovered, marketed, and launched into the market while taking safety concerns FDA reviews new medications and devices promptly and does a respectable job of attempting to safeguard the public. However, scientific considerations are only one part of the regulatory equation due to incentives for speed, conflicts of interest in decision-making, restricted legislative mandates, low funds, and limited surveillance once products access the market. These restrictions may result in patients being unnecessarily exposed to medicines whose hazards outweigh their benefits, deceptive advertising of new medications, and the promotion of less effective over more successful treatments.

Cancer Stem Cells in Oncology: A Historical Overview

2024-04-15T09:28:42+00:00

In the past, developments in cancer research have produced new medications that greatly enhance patient outcomes and a growing understanding of the path physiology of the disease. Still, a large number of patients experience resistance to therapy, recurrence, or metastasis, and ultimately pass away from their illness. Based on empirical data, it has been determined that a subset of cancer cells known as cancer stem cells (CSCs) have characteristics with normal stem cells, such as the ability to self-renew, differentiate, and proliferate. The mechanisms that control these stemness attributes which are lost after differentiation include STAT3, NAG, NOTCH, WNT, and also HEDGEHOG. These pathways are severely deregulated in CSCs as a result of genetic and epigenetic modifications. Preclinical models that target these CSCs by disrupting stemness pathways in conjunction with existing therapy methods have shown encouraging outcomes. Anti-CSC-based clinical studies are now at various phases of development as a result of this. The functions of CSCs along with stemness pathways in the therapy of oncology, as well as how these connections relate to clinical data, are covered in this review. Oncologists must comprehend how CSCs contribute to the advancement of cancer as well as how they can be targeted to enhance patient outcomes, since they may be able to explain the unfavourable clinical outcomes seen during therapy.

Leafy Vegetables Diversity and their Ethnomedicinal Use Against Gastrointestinal Disorders in Krishna District of AP

2024-03-15T10:22:15+00:00

The study lists the traditional medicinal applications of 62 plant species from 62 genera that the rural populations of Krishna district utilize to treat various illnesses and ailments. Oral use makes up half of the medicines or 45% of the therapeutic use. The majority of documented treatments come from species of herbs and trees. The most often used plant parts in the manufacture of medicines in the research region are the leaves and stem bark. For the treatment of gastrointestinal disorders, a vast array of medicinal plant species are accessible in the research domain (ulcers, stomachache, piles, constipation, gastric issues, diarrhoea, loose motions, sticky motion, digestion problems, loss of appetite, etc.). Therefore, valuable plants must be properly documented together with their current state and any traditional knowledge or practices that may be unique to the area. This search will support scientific research aimed at finding novel dosage form formulations and new medicinal compounds.

A Note on the FDA’s Perspective on the Reformulation of Drug Products Containing Carbomer Manufactured using Benzene as Polymerization Solvent

2024-01-24T08:33:09+00:00

The US Food and Drug Administration (FDA) have implemented the guidance for the carbomer that uses benzene as a residual solvent immediately. The course record has been summarized in this authoritative note. The course record covers the carbomer grades, for instance, 934, 934P, 940, 941, and 1342 containing 5000 ppm, which will be disposed of from the USP Monograph. The required solvents for the synthesis of carbomers are described. Therefore, the guidance covers the semisolid, immediate, and modified release oral solid, and Oral suspension formulations containing carbomer. The 1, 2, and 3 levels of progress are depicted with the possible impact on the estimation structure. The managerial necessities concerning the level of progress and required examinations are referred to. The level of progress, required study and the technique for regulatory recording have been portrayed thoroughly. The scale-up and post-approval changes details elaborated for the multiple dosage forms in brief. The future point is to assess the less expensive methods by dissecting the hydration of the polymers.

A Comprehensive Review on Parthenium Hysterophorous Whole Plant

2024-02-17T04:45:13+00:00

Conducting a thorough investigation into the phytochemical makeup of Parthenium hysterophorus involved a systematic approach, encompassing the collection of plant material, extraction, and isolation of bioactive compounds. Differential solubility yielded varied results, with the methanolic extract proving to be the most effective. Spectrum analysis confirmed the successful separation of chemical components, paving the way for exploring the therapeutic potential of these compounds. Utilizing advanced spectroscopic techniques, four bioactive compounds Parthenin, Dacousterol, 3, 7 dimethyl quercetagetin, and Stigmasterol were isolated and characterized. These compounds exhibit diverse structural features, suggesting broad therapeutic applications and positioning them as promising candidates for novel therapeutic agents. The research underscores the dynamic nature of natural product exploration and emphasizes the need for sustained efforts to uncover additional bioactive compounds from Parthenium hysterophorus. In summary, the isolation and characterization of these compounds significantly contribute to phytochemical research, highlighting the enduring importance of natural products in the search for new therapeutic agents.