Forced degradation studies for Drug Substances and Drug Products-Scientific and Regulatory Considerations (original) (raw)

An Introduction to Forced degradation studies for drug substances and drug products

MUSKAN singh

Journal of emerging technologies and innovative research, 2021

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Forced Degradation Studies: Practical Approach - Overview of Regulatory Guidance and Literature for the Drug Products and Drug Substances

kishore hotha

International Research Journal of Pharmacy, 2013

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Technical Considerations of Forced Degradation Studies of New Drug Substances and Product: Regulatory Perspectives

Parul Singh

Journal of Drug Delivery and Therapeutics, 2018

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Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s

Rajveer Bhaskar

Journal of Drug Delivery and Therapeutics

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Review: Development of forced degradation studies of drugs

Scholar Science Journals

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Development of forced degradation and stability indicating studies of drugs—A review

Dr. Prajesh Prajapati

Journal of Pharmaceutical Analysis, 2014

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Author's Accepted Manuscript Development of forced degradation and stability indicating studies of drugs – A review

yang gattuso

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Forced Degradation Study: An Important Tool in Drug Development AB Roge, PS Tarte, MM Kumare, Dr. G R Shendarkar, Dr. S M Vadvalkar

Mangesh Kumare

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A review article – development of forced degradation and stability indicating studies for drug substance and drug product

IJRPP Journal

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Forced Degradation Studies: Regulatory Considerations and Implementations in Analytical Method Development and Validation

Chetan Bhalgat

2018

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Available guidance and best Practices for Conducting Forced degradation Studies Pharmaceutical Technology

Dan Reynolds

2002

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Understanding and evaluation of different degradation pathways and stability of drug product with active substance prone to chemical and physical degradation

Packa Antovska

Macedonian Pharmaceutical Bulletin

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Systematic strategies for degradation kinetic study of pharmaceuticals: an issue of utmost importance concerning current stability analysis practices

Tarang Jadav

Journal of Analytical Science and Technology, 2022

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In situ degradation: a new concept for system suitability tests in monographs of the European Pharmacopoeia

Ulrich Rose

Journal of Pharmaceutical and Biomedical Analysis, 1998

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Degradation Rate Observations as a Function of Drug Load in Solid-State Drug Products

Steven Baertschi

Journal of Pharmaceutical Sciences, 2019

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Forced Degradation – A Review

NAGASAMY VENKATESH

Biomedical Journal of Scientific and Technical Research, 2022

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The use of liquid chromatography±mass spectrometry for the identi®cation of drug degradation products in pharmaceutical formulations

Marco Garzotti

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Forced Degradation Study an Essential Approach to Develop Stability Indicating Method

Ankit Kushwaha

Journal of Chromatography & Separation Techniques

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Review: Force Degradation Studies

Manuni Patel

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Strategies To Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products

Andrew Teasdale

Organic Process Research & Development, 2015

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Forced Degradation Study and Development of a Stability-Indicating Method for Amoxicillin Capsules According to ANVISA Guidelines

Margareth Gallo

2021

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Forced degradation of nepafenac: Development and validation of stability indicating UHPLC method

Irena Nekola

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A new approach to forced degradation studies using zolmitriptan tablets by a sensitive liquid chromatographic method

World Journal of Pharmaceutical Sciences

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Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Swapan Roychowdhury, kishore hotha

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Critical review: Significance of Force degradation study with respect to current Pharmaceutical Scenario

Bill Zhuang

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Study of the forced degradation behavior of prasugrel hydrochloride by Liquid Chromatography with Mass spectrometry and liquid chromatography with NMR detection and prediction of the toxicity of the characterized degradation products

Tarun Handa

Journal of Separation Science, 2015

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Forced Degradation and Stability Indicating Studies of Imatinib Tablet

Hasin Farzana

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IDENTIFICATION, SEPARATION, AND CHARACTERIZATION OF DEGRADATION PRODUCTS OF TRIAMCINOLONE HEXACETONIDE USING LC AND LC-MS/MS

International Journal of Applied Pharmaceutics (IJAP), BHAVNA SUNIL MAHAJAN

International Journal of Applied Pharmaceutics, 2024

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A Review on Stress Testing of Drug Substances and Drug Product

poonam patil

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Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: A comprehensive review

Bappaditya Chatterjee

International Journal of Pharmaceutics, 2018

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Analytical methodologies for discovering and profiling degradation-related impurities

Steven Baertschi

TrAC Trends in Analytical Chemistry, 2006

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Forced Degradation Study of Quinapril by UPLC-DAD and UPLC/ MS/MS: Identification of By-products and Development of Degradation Kinetics

Maha Dendeni

Current Pharmaceutical Analysis, 2013

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Validated Stability-indicating High-performance Liquid Chromatographic Method for Estimation of Degradation Behaviour of Eberconazole Nitrate and Mometasone Furoate in Cream Formulation

Milind Ubale

Indian Journal of Pharmaceutical Sciences, 2013

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