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Kaur J.,CT Institute of Pharmaceutical science
International Journal of Pharmaceutical Sciences Review and Research | Year: 2014

In Pharmaceutical Industry, Regulatory Affairs Department makes an interface between the regulatory authorities and pharmaceutical industry. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products. This professional can play a key role in guiding drug development strategy in an increasingly global environment and has an important role for submitting the newly discovered drug products approval documents to the US FDA regulatory authorities and to carry out all the practices required for obtaining the drug products approval. This article mainly focuses on the US FDA drug approval strategies. These strategies playing core job in the pharmaceutical industry. These strategies having all the guidelines which are indispensable part of the IND, NDA and ANDA drug approval applications. It plays a significant role in sequence for registration of newly exposed products and also providing the guidelines which is helpful preparing the registration documents to regulatory authorities. Source


Kaur R.,CT Institute of Pharmaceutical science | Kaur H.,University of Punjab
Oriental Journal of Chemistry | Year: 2015

Medicinal plants offer a hope for developing alternate medicines for the treatment of Tuberculosis.. The present study was done to evaluate in vitro anti-tubercular activity of five medicinal plants viz., Syzygium aromaticum, Piper nigrum, Glycyrrhiza glabra, Aegele marmelos and Lawsonia inermis. Solvent extracts of Syzygium aromaticum, Piper nigrum, Glycyrrhiza glabra, Aegele marmelos and Lawsonia inermis were tested in vitro for their activity against Mycobacterium tuberculosis H37Rv strain using Microplate Alamar Blue Assay. Activity in MABA was evaluated by lowest concentration of sample that prevents color change to pink. Extracts of all the five plants Syzygium aromaticum, Piper nigrum, Glycyrrhiza glabra, Aegele marmelos and Lawsonia inermis exhibited anti-tuberculosis activity, the proportion of inhibition of these plants extracts for M. tuberculosis H37Rv, inhibition was found to be 0.8μg/ml, 50μg/ml, 12.5μg/ml and 50μg/ml respectively. Our findings showed that all these plants exhibited activity against MDR isolates of H37Rv M. tuberculosis strain. Further studies aimed at isolation and identification of active substances from the extracts needs to be carried out. Source


Kumar V.,Punjab Technical University | Kharb R.,CT Institute of Pharmaceutical science | Chaudhary H.,P.A. College
International Journal of Biological Macromolecules | Year: 2016

Our research objective was to optimize and design nano-biosystem of Isradipine (IDP) via novel bioenhancer (Rutin) loaded solid-lipid nanobioparticles (ANbp) using Taguchi design (TgD) methodology. Firstly, preliminary screening of solid lipid nanoparticles (SLNps) formulation core factors (A, B & C; Lipoid's, poly-acid, sonication time respectively at fixed dose of model drug were assessed on entrapment efficiency & particle size; R1 & R2) by performed experimentally of three factor three levels orthogonal L27 array. Consequently, signal to noise (S/N) ratio plot of responses were drawn to predict better quality fitted-levels of significant factor for eminence optimization. Further, optimized quality spaces composition was used via enhancer (Rutin) to design advanced bio-formulation (ANbp) and done its evaluation (entrapment efficiency, particle size, drug release & kinetics). As designed, ANbp results showed better sustained (86.54% as compared to control SLNps 94.48% in 24 h) release, kinetics & stability behavior with good entrapment efficiency (97.58%) and desired smaller particle size (108 nm). Therefore, statistically (TgD) optimization strategy would be considered to design nano-drug delivery system with bio-agent in-order to improve oral bioavailability of antihypertensive agents. © 2016 Source


Kharb R.,CT Institute of Pharmaceutical science | Yar M.S.,Jamia Hamdard University | Sharma P.C.,Kurukshetra University
Current Medicinal Chemistry | Year: 2011

Research and development for novel substances possessing anti-infective activity have attracted considerable attention due to the escalating resistance towards conventional antibiotics. Therefore, the discovery and development of effective antimicrobial drugs with novel mechanism of action have become an insistent task for infectious diseases research programs. Triazole scaffold has been consistently rewarded as a promising versatile lead molecule with a pivotal position in modern medicinal chemistry. The literature reveals that this heterocyclic moiety has drawn attention of the chemists, pharmacologists, microbiologists and other researchers owing to its indomitable biological potential as anti-infective agents. The present communication is a cogent attempt to review the chemistry and antimicrobial activities of triazole derivatives reported in recent scientific literature. The biological profiles of these new triazole derivatives represent a fruitful matrix for further development as promising and superior anti-infective medicinal agents. © 2011 Bentham Science Publishers Ltd. Source


Kharb R.,CT Institute of Pharmaceutical science | Bansal K.,CT Institute of Pharmaceutical science | Sharma A.K.,CT Institute of Pharmaceutical science
Der Pharma Chemica | Year: 2012

The worldwide problem of microbial resistance has drawn utmost attention for medicinal chemists because of failure of currently available antimicrobial therapy against microbial infections. Therefore, there is an urgent need to develop novel antimicrobial agents with different mode of actions. In the search of better antimicrobial agents, different heterocyclic compounds have been explored and out of them piperazine derivatives have shown a broad spectrum of pharmacological activities like antibacterial, antifungal, antitubercular, anticancer, antiviral, antioxidant activities etc. This communication is focused on to review antimicrobial activities of different piperazine derivatives in detail and the valuable information provided in this manuscript may help in the drug design and development of better antimicrobial agents. Source

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