プロフィール詳細

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Dr. Siddharth C.に依頼

Netherlands

Pharmaceutical physician with 20+ years of experience in clinical development, medical writing and pharmacovigilance

プロフィール概要

Dr Siddarth Chachad is a pharmaceutical physician with over 20 years of experience in the areas of medical affairs, drug safety and global clinical development of new medicinal products including innovative drugs, complex generics, branded generics, biologics and biosimilars, medical devices, herbals, nutraceuticals & cosmetics, advanced therapies and even vaccines. He is a strategic leader in translational research, medical affairs and drug safety with expert knowledge of legal and regulatory requirements across these areas of expertise. He is a strong proponent of clinico-regulatory innovation, digital transformation and patient centricity in the development of new medicines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including developed markets such as EU and US, as well as emerging markets such as India, Russia, China and Brazil. He is an acclaimed speaker at various international seminars and conferences on clinical research and pharmacovigilance, and an expert faculty in the functional areas of drug development and patient safety at the teaching and training institutes in India, Czechia and Netherlands. He has published extensively in the peer-reviewed journals and has written a book chapter on clinical development in reputed Burger's Medicinal Chemistry, Drug Discovery and Development.

専門分野

• ☆ Drug Development
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Affairs
• ☆ Regulatory Affairs
• ☆ Medical Writing

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Feasibility Study, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Founder

Reguclin Consulting

- 現在

Founder/Consultant

Reguclin Consulting

3月 2023 - 現在

学歴

Masters (Pharmacology)

University of Hertfordshire

- 現在

MBBS

University of Mumbai

- 現在

Masters

University of Hertfordshire

9月 2002 - 9月 2004

認定資格

• Certification in International Project Management (CIPM)

  CIPM

  1月 2010 - 現在

出版物

JOURNAL ARTICLE

Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Tausif Ahmed, Chachad S (2023). Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective . AAPS PharmSciTech.

Gautam Vijaywargi, Sivacharan Kollipara, Tausif Ahmed, Chachad S (2022). Predicting transporter mediated drug-drug interactions via static and dynamic physiologically based pharmacokinetic modeling: A comprehensive insight on where we are now and the way forward . Biopharmaceutics & drug disposition.

Bhattiprolu AK, Kollipara S, Ahmed T, Chachad S (2022). Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space . Journal of pharmaceutical sciences.

Aishwarya R, Murthy A, Ahmed T, Chachad S (2022). A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation . Journal of pharmaceutical sciences.

Sivacharan Kollipara, Tausif Ahmed, Chachad S (2022). Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development . AAPS PharmSciTech.

Sivacharan Kollipara, Tausif Ahmed, Bhattiprolu AK, Chachad S (2021). In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies . Biopharmaceutics & drug disposition.

Jaiswal S, Ahmed T, Kollipara S, Bhargava M, Chachad S (2021). Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets . Drug development and industrial pharmacy.

Chachad SS, Gole M, Malhotra G, Naidu R (2014). Comparison of pharmacokinetics of two fenofibrate tablet formulations in healthy human subjects . Clinical therapeutics.

Chachad S, Purandare S, Malhotra G, Naidu R (2012). Comparison of pharmacokinetics and safety profiles of two capecitabine tablet formulations in patients with colon, colorectal or breast cancer . Cancer chemotherapy and pharmacology.

BOOK CHAPTER

SIDDHARTH CHACHAD (2021). Clinical Development - A Primer. Burger's Medicinal Chemistry and Drug Discovery.