プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Abhay G.に依頼

India

Versatile Pharmaceutical Writer/Editor with Multiple Journal Articles

プロフィール概要

I am a pharmaceutical scientist (Ph.D.) with an extensive publication record, including multiple book chapters, peer-reviewed journal articles, and blog posts. A portfolio of my work is available at https://scholar.google.co.in/citations?user=sLe-jScAAAAJ and https://www.linkedin.com/in/abhayguptaphd/detail/recent-activity/shares/. Having worked for the US-FDA for over ten years, I am familiar with content writing in this field using clear and easy-to-understand language. I am an analytical thinker with meticulous and professional writing, editing, and communication skills. I have the ability and experience to effectively interrogate the available information/data and transform it into evidence-based, audience-appropriate, and compelling content. I can provide high-quality service customized to your needs. Please feel free to contact me for more information.

専門分野

• ★ Regulatory Writing
• ★ Technical & Scientific Writing
• ★ Manuscript & Journal Article Writing
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Data Visualization

職務経験

COO (Planning)

Shalaks Healthcare

4月 2015 - 12月 2020

Sr. Staff Fellow

U.S. Food and Drug Administration

12月 2004 - 2月 2015

学歴

Ph. D. (Industrial and Physical Pharmacy)

Purdue University

8月 2000 - 12月 2004

M. Pharm. (Pharmacognocy) (Poona College of Pharmacy)

University of Pune

9月 1998 - 6月 2000

B. Pharm.

University of Rajasthan

9月 1992 - 5月 1997

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

(2016). Dose uniformity of scored and unscored tablets: Application of the FDA Tablet Scoring Guidance for Industry. PDA J Pharm Sci Technol.

(2016). Risk based in vitro performance assessment of extended release abuse deterrent formulations. Int J Pharm.

(2016). To investigate the influence of machine operating variables on formulations derived from lactose types in capsule filling: part 2. Drug Dev Ind Pharm.

(2015). An index for evaluating difficulty of Chewing Index for chewable tablets. Drug Dev Ind Pharm.

(2015). Characterization and selection of suitable grades of lactose as functional fillers for capsule filling: part 1. Drug Dev Ind Pharm.

(2015). Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride. Drug Dev Ind Pharm.

Cantor, S.L., Gupta, A., Khan, M.A.(2014). Analytical methods for the evaluation of melamine contamination . Journal of Pharmaceutical Sciences. 103. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 539-544.

Khan, S.R., Kona, R., Faustino, P.J., Gupta, A., Taylor, J.S., Porter, D.A., Khan, M.(2014). United States food and drug administration and department of defense shelf-life extension program of pharmaceutical products: Progress and promise . Journal of Pharmaceutical Sciences. 103. (5). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1331-1336.

Gupta, A., Khan, M.A.(2013). Challenges of pediatric formulations: A FDA science perspective . International Journal of Pharmaceutics. 457. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 346-348.

(2013). Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay . Journal of Analytical Sciences, Methods and Instrumentation.

Xu, X., Gupta, A., Faustino, P., Sathe, P.M., Sayeed, V.A., Khan, M.A.(2013). Development and validation of a HPLC method for dissolution and stability assay of liquid-filled cyclosporine capsule drug products . AAPS PharmSciTech. 14. (3). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 959-967.

Xu, X., Gupta, A., Sayeed, V.A., Khan, M.A.(2013). Process analytical technology to understand the disintegration behavior of alendronate sodium tablets . Journal of Pharmaceutical Sciences. 102. (5). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1513-1523.

Khan, M.A., Wu, K., Gupta, A.(2012). FDA: Contribution to developing pediatric formulations and transatlantic collaboration . International Journal of Pharmaceutics. 435. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 146-148.

Yang, Y., Gupta, A., Carlin, A.S., Faustino, P.J., Lyon, R.C., Ellison, C.D., Rothman, B., Khan, M.A.(2010). Comparative stability of repackaged metoprolol tartrate tablets . International Journal of Pharmaceutics. 385. (1-2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 92-97.

Collier, J.W., Shah, R.B., Gupta, A., Sayeed, V., Habib, M.J., Khan, M.A.(2010). Influence of formulation and processing factors on stability of levothyroxine sodium pentahydrate . AAPS PharmSciTech. 11. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 818-825.

Gupta, A., Hunt, R.L., Shah, R.B., Sayeed, V.A., Khan, M.A.(2009). Disintegration of highly soluble immediate release tablets: A surrogate for dissolution . AAPS PharmSciTech. 10. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 495-499.

Sulub, Y., Wabuyele, B., Gargiulo, P., Pazdan, J., Cheney, J., Berry, J., Gupta, A., Shah, R., Wu, H., Khan, M.(2009). Real-time on-line blend uniformity monitoring using near-infrared reflectance spectrometry: A noninvasive off-line calibration approach . Journal of Pharmaceutical and Biomedical Analysis. 49. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 48-54.

Gupta, A., Ciavarella, A.B., Rothman, B., Faustino, P.J., Khan, M.A.(2009). Stability of gabapentin 300-mg capsules repackaged in unit dose containers . American Journal of Health-System Pharmacy. 66. (15). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1376-1380.

Gupta, A., Hamad, M.L., Tawakkul, M., Sayeed, V.A., Khan, M.A.(2009). Difference in the lubrication efficiency of bovine and vegetable-derived magnesium stearate during tabletting . AAPS PharmSciTech. 10. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 500-504.

Gupta, A., Ciavarella, A.B., Sayeed, V.A., Khan, M.A., Faustino, P.J.(2008). Development and application of a validated HPLC method for the analysis of dissolution samples of gabapentin drug products . Journal of Pharmaceutical and Biomedical Analysis. 46. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 181-186.

Hamad, M.L., Gupta, A., Shah, R.B., Lyon, R.C., Sayeed, V.A., Khan, M.A.(2008). Functionality of magnesium stearate derived from bovine and vegetable sources: Dry granulated tablets . Journal of Pharmaceutical Sciences. 97. (12). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 5328-5340.

Gupta, A., Hunt, R.L., Khan, M.A.(2008). Influence of tablet characteristics on weight variability and weight loss in split tablets . American Journal of Health-System Pharmacy. 65. (24).

Volpe, D.A., Gupta, A., Ciavarella, A.B., Faustino, P.J., Sayeed, V.A., Khan, M.A.(2008). Comparison of the stability of split and intact gabapentin tablets . International Journal of Pharmaceutics. 350. (1-2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 65-69.

Ciavarella, A.B., Gupta, A., Sayeed, V.A., Khan, M.A., Faustino, P.J.(2007). Development and application of a validated HPLC method for the determination of gabapentin and its major degradation impurity in drug products . Journal of Pharmaceutical and Biomedical Analysis. 43. (5). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1647-1653.

Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R.(2005). Effect of the variation in the ambient moisture on the compaction behavior of powder undergoing roller-compaction and on the characteristics of tablets produced from the post-milled granules . Journal of Pharmaceutical Sciences. 94. (10). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 2314-2326.

Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R.(2005). Influence of ambient moisture on the compaction behavior of microcrystalline cellulose powder undergoing uni-axial compression and roller-compaction: A comparative study using near-infrared spectroscopy . Journal of Pharmaceutical Sciences. 94. (10). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 2301-2313.

Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R.(2005). Real-time near-infrared monitoring of content uniformity, moisture content, compact density/tensile strength, and young's modulus of roller compacted powder blends . Journal of Pharmaceutical Sciences. 94. (7). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1589-1597.

Gupta, A., Peck, G.E., Miller, R.W., Morris, K.R.(2004). Nondestructive Measurements of the Compact Strength and the Particle-Size Distribution after Milling of Roller Compacted Powders by Near-Infrared Spectroscopy . Journal of Pharmaceutical Sciences. 93. (4). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1047-1053.

Miller, R.W., Gupta, A.(2004). Roller compaction: A PAT application using near-infrared in-process mapping, monitoring and characterization . American Pharmaceutical Review. 7. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 69-76+103.

BOOK CHAPTER

(2015). Scientific and Regulatory Considerations in Product Development . Pharmaceutical Sciences Encyclopedia.

(2014). Regulatory considerations in development of amorphous solid dispersions . Amorphous Solid Dispersions. Advances in Delivery Science and Technology.

(2013). Consistency of Pharmaceutical Products: An FDA Perspective on Hot-Melt Extrusion Process. Melt Extrusion.

(2010). Stability of Split Tablets . Pharmaceutical Stability Testing to Support Global Markets. Biotechnology: Pharmaceutical Aspects.

(2005). Roller Compaction Scale-Up. Pharmaceutical Process Scale-Up, Second Edition.

BOOK

Gupta, A., Khan, M.A.(2012). Hot-Melt Extrusion: An FDA Perspective on Product and Process Understanding . Hot-Melt Extrusion: Pharmaceutical Applications. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 323-331.

Gupta, A., Sayeed, V.A., Khan, M.A.(2010). The science and regulatory perspectives of pharmaceutical suspensions . Pharmaceutical Suspensions: From Formulation Development to Manufacturing. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 265-283.

CONFERENCE PAPER

(2003). Near infrared monitoring of roller compaction. BIENNIAL CONFERENCE-INSTITUTE OF BRIQUETTING AND AGGLOMERATION.