プロフィール詳細

プロジェクトを作成

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Madhoo P.に依頼

United States

Subject Matter Expert in Ophthalmology, Preclinical, Pharmacology, Scientific Writing

プロフィール概要

Life science researcher with over 15 years of full time work experience at research institutions, universities, and biopharma industries. Expert in nonclinical pharmacology and drug delivery in the filed of ophthalmology. My Services Includes- 1) Plan, design, and oversee the execution of clinical and nonnlincal studies at CRO within USA, Europe, or Asia for pharmacokinetics (PK), toxicology and safety studies to support preclinical strategy and clinical development efforts. 2) Draft, review and edit study protocols and reports related to non-clinical studies (GLP/Non-GLP) 3) Analyze the raw study data from a spreadsheets to a presentable or reportable format with the helps of tables or figures. 4) Estimation of Pharmacokinetics parameters (Cmax, Tmax, AUC, CL, Vd, etc) for nonclinical or clinical study for intravascular or extravascular dosing using Phoenix WinNonlin or other PK programs. 5) Author, review (DIR-Data Integrity Review), and edit non-clinical sections of regulatory documents such as preIND, IND, IB, DSUR, etc. 6) Draft/Review protocol or report for the bio-analytical method development for small as well as large molecules (biologics) to best match regulatory standards. Hourly charge depends upon type of service. But can be negotiated based on the study needs.

専門分野

• ★ Drug Development
• ★ Small Molecule Drug Development
• ★ Pharmaceutical Formulation
• ☆ Materials Science & Engineering
• ☆ Nanotechnology
• ☆ Biochemistry
• ☆ Biochemical Assays
• ☆ Cell Biology
• ☆ Biotechnology & Bioengineering
• ☆ Nanobiotechnology
• ☆ Biosafety Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Ophthalmology
• ☆ Neuro-Ophthalmology
• ☆ Endocrinology
• ☆ Diabetes
• ☆ Pharmaceutical Management
• ☆ Drug Delivery Technologies
• ☆ Liposomes
• ☆ Pharmaceutical Technology
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Formulation

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Image Analysis, Data Visualization, Data Cleaning, Data Processing

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Product Validation

職務経験

Sr. Scientist

Ocular Therapeutix

9月 2022 - 8月 2024

Scientists

Ora Inc

8月 2021 - 8月 2022

PostdoctoralResearcher

University of Colorado Denver School of Medicine

3月 2016 - 7月 2021

Visiting Research Associate

University of Colorado Denver School of Medicine

4月 2014 - 2月 2016

ICMR-Senior Research Fellow

National Institute of Nutrition, Hyderabad, India

11月 2010 - 4月 2014

Project Fellow

National Institute of Nutrition, Hyderabad, India

6月 2010 - 11月 2010

Graduate Research Assistant / Research Assistant

National Institute of Nutrition, Hyderabad, India

1月 2008 - 6月 2010

学歴

PhD (Biochemistry)

Osmania University

11月 2010 - 6月 2015

M.Sc. (Biotechnology)

Swami Ramanand Teerth Marathwada University

5月 2005 - 5月 2007

認定資格

• NIH Principles of Clinical Pharmacology

  National Institute of Health (NIH)

  1月 2024 - 現在

• Training Program, Regulatory Affairs

  Duke University School of Medicine

  9月 2023 - 11月 2023

• NIH Introduction to the Principles and Practice of Clinical Research 2022-2023

  National Institute of Health (NIH)

  7月 2023 - 7月 2023

出版物

JOURNAL ARTICLE

(2018). Brain Distribution and Metabolism of Flupirtine, a Nonopioid Analgesic Drug with Antiseizure Effects, in Neonatal Rats . Pharmaceutics.

(2018). Targeted delivery of YSA-functionalized and non-functionalized polymeric nanoparticles to injured pulmonary vasculature . Artificial cells, nanomedicine, and biotechnology.

(2016). Vanillic Acid Ameliorates Cationic Bovine Serum Albumin Induced Immune Complex Glomerulonephritis in BALB/c Mice . Drug development research.

Prakash V. Diwan, B. Dinesh Kumar, G. Bhanuprakash Reddy, Madhoosudan A. Patil, Manikanta V. Kothamasu, Rahul P. Kshirsagar (2015). Geranium oil ameliorates endothelial dysfunction in high fat high sucrose diet induced metabolic complications in rats . Journal of Functional Foods.

G. Bhanuprakash Reddy, Myadara Srinivas, Uday Kumar Putcha, Palla Suryanarayana, Madhoosudan A. Patil (2014). Evaluation of Neonatal Streptozotocin Induced Diabetic Rat Model for the Development of Cataract . Oxidative Medicine and Cellular Longevity.

Charitra N. Grama, Palla Suryanarayana, Madhoosudan A. Patil, Ganugula Raghu, Nagalla Balakrishna, M. N. V. Ravi Kumar, Geereddy Bhanuprakash Reddy (2013). Efficacy of Biodegradable Curcumin Nanoparticles in Delaying Cataract in Diabetic Rat Model . PLoS ONE.

(2013). Efficacy of biodegradable curcumin nanoparticles in delaying cataract in diabetic rat model . PloS one.

(2011). Insulin resistance mediated biochemical alterations in eye lens of neonatal streptozotocin-induced diabetic rat. Indian journal of experimental biology.

(2011). Temperature-dependent coaggregation of eye lens αB- and β-crystallins . Biochemical and biophysical research communications.

Palla Suryanarayana, Madhoosudan A. Patil, Geereddy Bhanuprakash Reddy, Megha Saraswat, Paduru Yadagiri Reddy, Nagalla Balakrishna (2010). Antiglycating potential of Zingiber officinalis and delay of diabetic cataract in rats. Molecular Vision.