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Hire Dr. Abhay G.

India

USD 75 /hr

Versatile Pharmaceutical Writer/Editor with Multiple Journal Articles

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

COO (Planning)

Shalaks Healthcare

April 2015 - December 2020

Sr. Staff Fellow

U.S. Food and Drug Administration

December 2004 - February 2015

Education

Ph. D. (Industrial and Physical Pharmacy)

Purdue University

August 2000 - December 2004

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

University of Pune

September 1998 - June 2000

B. Pharm.

University of Rajasthan

September 1992 - May 1997

Certifications

• Certification details not provided.

Publications

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). p. 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). p. 1331-1336.

Gupta, A., Khan, M.A.(2013). Challenges of pediatric formulations: A FDA science perspective . International Journal of Pharmaceutics. 457. (1). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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). p. 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. p. 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. p. 265-283.

CONFERENCE PAPER

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