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Ghandinagar, India

Chokshi N.A.,Torrent Research Center
Journal of Generic Medicines | Year: 2013

Prior to Pediatric Research Equity Act's enactment, Food and Drug Administration had approved several suitability petitions to permit abbreviated new drug applications to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference-listed drugs. Pediatric Research Equity Act does not impose pediatric assessment requirements on abbreviated new drug applications for generic drugs. However, abbreviated new drug applications submitted under an approved suitability petition under section 505(j)(2)(C) of the Act and the said difference from the reference-listed drugs are subject to the pediatric assessment requirements that Pediatric Research Equity Act imposes. In the federal notice dated 23 February 2007, Food and Drug Administration explained that the approval of 128 suitability petitions was being withdrawn because abbreviated new drug applications were never submitted and Pediatric Research Equity Act requires that all applications submitted on or after 1 April 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration containing an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. Underlining information in this article helps in understating the Pediatric Research Equity Act, pediatric assessment for suitability petitions, pediatric review committee and its role, types of pediatric waivers, and its importance in suitability petitions. Also there are several examples provided for the Pediatric Research Equity Act assessment in recently filed suitability petitions by the various firms. © SAGE Publications. Source

Virsdoia V.,Dishman Pharmaceuticals and Chemicals Ltd. | Manvar A.,Jubilant Organosys | Desai B.,Beckman Coulter Inc. | Parecha A.,ATRI Pharma. Pvt. Ltd | And 7 more authors.
Chemical Biology and Drug Design | Year: 2010

The resurgence of tuberculosis and the emergence of multidrug-resistant strains of Mycobacteria necessitate the search for new classes of antimycobacterial agents. We have synthesized a small library of 50 analogues of 4-(arylamino)coumarins with various aromatic amines at the C 4-position of the coumarin scaffold. The compounds were evaluated for antimycobacterial activity against Mycobacterium tuberculosis H 37Rv with rifampicin as the standard. Of the molecules synthesized, compound 9 was found to be most potent with a minimum inhibitory concentration >6.25 lg/mL for 100% inhibition. In an effort to develop new and more effective molecules in this series, the relationship between structure and activity was investigated by comparative molecular field analysis. Various models were generated using comparative molecular field analysis alone and comparative molecular field analysis plus a hydropathy field (HINT). In all, eight models were generated with atom-fit and field-fit alignment strategies. The comparative molecular field analysis models (Models 3a and 4a) based on field-fit alignment were the best with statistically good correlation coefficients (r 2) and cross-validated q 2. The values of r 2 pred for the validation set were 0.469 and 0.516. Based on the comparative molecular field analysis contours, some insights into the structure-activity relationship of the compounds could be gained. © 2010 John Wiley & Sons A/S. Source

Mane U.R.,M. S. University of Baroda | Mane U.R.,Torrent Research Center | Mohanakrishnan D.,Malaria Research Laboratory | Sahal D.,Malaria Research Laboratory | And 3 more authors.
European Journal of Medicinal Chemistry | Year: 2014

Novel pyrido[1,2-a]pyrimidin-4-ones have been synthesized and evaluated for their antimalarial activity by SYBR Green I assay against erythrocytic stages of chloroquine (CQ) sensitive Pf 3D7 strain. The antimalarial screening of 42 different compounds revealed that 3-Fluorobenzyl(4-oxo-4H-pyrido [1,2-a]pyrimidin-3-yl)carbamate (21, IC50 value 33 μM) and 4-Oxo-N-[4-(trifluoromethyl)benzyl]-4H-pyrido[1,2-a]pyrimidine-3-carboxamide (37, IC50 value 37 μM) showed moderate antimalarial activity. Cytotoxicity study was performed against mammalian cell line (Huh-7) by using the MTT assay for the moderately active compounds. Structural activity relationship (SAR) studies displayed that B-ring unsubstituted pyrido[1,2-a]pyrimidine scaffold is responsible for the antimalarial activities of the evaluated derivatives. This SAR based antimalarial screening supported that pyrido[1,2-a]pyrimidin-4-one can be considered as a lead heterocyclic structure for further development of more potent derivatives for antimalarial activity. © 2014 Elsevier Masson SAS. All rights reserved. Source

Manvar A.T.,Saurashtra University | Virsodia V.R.,Jubilant Organosys | Upadhyay K.D.,Torrent Research Center | Manvar D.R.,Jubilant Organosys | And 5 more authors.
Molecular Diversity | Year: 2010

In continuation of our research program on new antitubercular agents, this article is a report of the synthesis of 97 various symmetrical, unsymmetrical, and N-substituted 1,4-dihydropyridines. The synthesized molecules were tested for their activity against M. tuberculosis H 37Rv strain with rifampin as the standard drug. The percentage inhibition was found in the range 3-93%. In an effort to understand the relationship between structure and activity, 3D-QSAR studies were also carried out on a subset that is representative of the molecules synthesized. For the generation of the QSAR models, a training set of 35 diverse molecules representing the synthesized molecules was utilized. The molecules were aligned using the atom-fit technique. The CoMFA and CoMSIA models generated on the molecules aligned by the atom-fit method show a correlation coefficient (r 2) of 0.98 and 0.95 with cross-validated r 2(q 2) of 0.56 and 0.62, respectively. The 3D-QSAR models were externally validated against a test set of 19 molecules (aligned previously with the training set) for which the predictive r 2(r 2 pred) is recorded as 0.74 and 0.69 for the CoMFA and CoMSIA models, respectively. The models were checked for chance correlation through y-scrambling. The QSAR models revealed the importance of the conformational flexibility of the substituents in antitubercular activity. Source

Patel H.B.,Torrent Research Center | Patel H.B.,Saurashtra University | Mohan A.,Shasun Pharmaceuticals | Joshi H.S.,Saurashtra University
Journal of AOAC International | Year: 2011

A simple RP-ultra-performance LC method was developed and validated for determination of impurities related to torsemide tablets. The rapid method provided adequate separation of all known related impurities and degradation products. Separation was achieved on a Zorbax SB-C18 column (50 × 4.6 mm id, 1.8 μm particle size) with binary gradient elution, and detection was performed at 288 nm. The drug product was subjected to oxidative, hydrolytic, photolytic, and thermal stress conditions to prove the specificity of the proposed method. The linearity and recovery were investigated for known impurities in the range of 0.025 to 1.0%, with respect to the drug concentration in the prepared sample. The linearity of the calibration curve for each of the impurities and torsemide was found to be very good (r 2 > 0.999). Relative response factors for each of the known impurities were established by the slope ratio method from the linearity study. Source

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