Search Results - "Charoo, Naseem A."

Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients by Charoo, Naseem A, Akanji, Omotayo, Rahman, Ziyaur, Khan, Aqeel A, Badshah, Aqal

“…Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their…”
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Data integrity issues in pharmaceutical industry: Common observations, challenges and mitigations strategies by Charoo, Naseem A., Khan, Mansoor A., Rahman, Ziyaur

“…[Display omitted] Data integrity (DI) reaffirms the pharmaceutical industry's commitment to manufacture drugs that are safe, effective and fulfil quality…”
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Selective laser sintering 3D printing - an overview of the technology and pharmaceutical applications by Charoo, Naseem A., Barakh Ali, Sogra F., Mohamed, Eman M., Kuttolamadom, Mathew A., Ozkan, Tanil, Khan, Mansoor A., Rahman, Ziyaur

“…Food and Drug Administration (FDA) has approved a drug product (Spritam®) and many medical devices manufactured by three-dimensional printing (3DP) processes…”
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Nitroso Impurities in Drug Products: An Overview of Risk Assessment, Regulatory Milieu, and Control Strategy by Charoo, Naseem A., Dharani, Sathish, Khan, Mansoor A., Rahman, Ziyaur

“…Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the fact that several nitrosamine precursors are frequently used in the…”
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Additive Manufacturing with 3D Printing: Progress from Bench to Bedside by Rahman, Ziyaur, Barakh Ali, Sogra F., Ozkan, Tanil, Charoo, Naseem A., Reddy, Indra K., Khan, Mansoor A.

“…Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to…”
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In-vivo evaluation in rats of colon-specific microspheres containing 5-fluorouracil by Rahman, Ziyaur, Kohli, Kanchan, Zhang, Shuang-Qing, Khar, Roop K., Ali, Mushir, Charoo, Naseem A., Tauseef, Mohammad, Shamsher, Areeg A. A., Mohammed, Noorullah N., Repka, Michael A.

“…The aims of this investigation were to determine the distribution in the gastrointestinal (GI) tract of Eudragit S‐100 encapsulated colon‐specific sodium…”
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Exploratory Investigation of the Limiting Steps of Oral Absorption of Fluconazole and Ketoconazole in Children Using an In Silico Pediatric Absorption Model by Cristofoletti, Rodrigo, Charoo, Naseem A, Dressman, Jennifer B

“…Due to the higher total clearance of certain drugs in children than in adults, it is recommended that, in such cases, higher relative doses on a…”
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride by Charoo, Naseem A, Abdallah, Daud B, Ahmed, Daoud T, Abrahamsson, Bertil, Cristofoletti, Rodrigo, Langguth, Peter, Mehta, Mehul, Parr, Alan, Polli, James E, Shah, Vinod P, Kambayashi, Atsushi, Dressman, Jennifer

“…Levocetirizine, a histamine H1-receptor antagonist, is prescribed to treat uncomplicated skin rashes associated with chronic idiopathic urticaria as well as…”
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Quality by design approach for formulation development: A case study of dispersible tablets by Charoo, Naseem A., Shamsher, Areeg A.A., Zidan, Ahmed S., Rahman, Ziyaur

“…The focus of the current investigations was to apply quality by design (QbD) approach to the development of dispersible tablets. Critical material and process…”
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Is the demonstration of bioequivalence for clavulanic acid required in amoxicillin–clavulanic acid orally administered immediate‐release products? by Charoo, Naseem A., Rahman, Ziyaur, Ali, Areeg Anwer

“…Objectives Bioequivalence (BE) criteria for amoxicillin–clavulanic acid (Co‐amoxiclav) oral formulations are based on 90% confidence interval for both…”
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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate by Charoo, Naseem A, Abdallah, Daud B, Bakheit, Ahmed Abdalla, Haque, Kashif Ul, Hassan, Hassan Ali, Abrahamsson, Bertil, Cristofoletti, Rodrigo, Langguth, Peter, Mehta, Mehul, Parr, Alan, Polli, James E, Shah, Vinod P, Tajiri, Tomokazu, Dressman, Jennifer

“…Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this…”
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Pharmaceutical product development: A quality by design approach by Pramod, Kannissery, Tahir, M, Charoo, Naseem, Ansari, Shahid, Ali, Javed

“…The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical…”
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Integrating biopharmaceutics risk assessment and in vivo absorption model in formulation development of BCS class I drug using the QbD approach by Charoo, Naseem A., Cristofoletti, Rodrigo, Kim, Sun K.

“…Objective: Clinically relevant critical quality attributes (CQA's) were identified for the development of generic drug products containing fluconazole and…”
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Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population by Charoo, Naseem A., Cristofoletti, Rodrigo, Dressman, Jennifer B.

“…Objectives The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein…”
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Ophthalmic Delivery of Ciprofloxacin Hydrochloride from Different Polymer Formulations: In Vitro and In Vivo Studies by Charoo, Naseem A., Kohli, Kanchan, Ali, Asgar, Anwer, Areeg

“…Abstract Reservoir-type ocular inserts were fabricated using sodium alginate containing ciprofloxacin hydrochloride as the core (drug reservoir) that was…”
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Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate by Charoo, Naseem A, Shamsher, Areeg A A, Lian, Lai Y, Abrahamsson, Bertil, Cristofoletti, Rodrigo, Groot, D W, Kopp, Sabine, Langguth, Peter, Polli, James, Shah, Vinod P, Dressman, Jennifer

“…Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage…”
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Characterization of 5-fluorouracil microspheres for colonic delivery by Rahman, Ziyaur, Kohli, Kanchan, Khar, Roop K., Ali, Mushir, Charoo, Naseem A., Shamsher, Areeg A. A.

“…The purpose of this investigation was to prepare and evaluate the colon-specific microspheres of 5-fluorouracil for the treatment of colon cancer. Core…”
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Tulsi oil as a potential penetration enhancer for celecoxib transdermal gel formulations by Shamsher, Areeg A., Charoo, Naseem A., Rahman, Ziyaur, Pillai, Krishna K., Kohli, Kanchan

“…Abstract The focus of the present study was to develop and evaluate the transdermal system of celecoxib. Transdermal gels composed of carbopol 940 in propylene…”
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Preparation of in situ-forming ophthalmic gels of ciprofloxacin hydrochloride for the treatment of bacterial conjunctivitis: in vitro and in vivo studies by Charoo, Naseem A, Kohli, Kanchan, Ali, Asgar

“…Sol-to-gel systems of ciprofloxacin hydrochloride were prepared utilizing the phase transition properties of hydroxy propyl methyl cellulose K 15 M grade…”
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Herbal and prescription weight loss products: awareness among pharmacists about efficacy and safety by Shamsher, Areeg A. A., Nadeem, Nada, Nadeem, Verda, Mutib, Khawla O., Mutib, Nasiba O., Charoo, Naseem A.

“…Background Weight loss medications that were traditionally considered safe and effective are associated with severe adverse effects. Aim The present work seeks…”
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