On the public citation graph

“New Drug” Designations for New Therapeutic Entities: New Active Substance, New Chemical Entity, New Biological Entity, New Molecular Entity

https://doi.org/10.1021/jm402001w
0 signed · 72 inferred · view as graph

Inferred edges come from two machine sources: sweeps of open repository metadata (mostly SSRN and Zenodo), and a bulk OpenAlex citation snapshot. Every row below is labelled with the one it came from. Neither is a complete citation index — absence here is not evidence of absence.

Is this your work? Sign in with ORCID and put your name on the claims that are yours.
Claim with ORCID
Reference health. See whether every reference in this work resolves to a known work and none has been retracted — and get a dated CiteStamped badge you can embed.
See reference health

What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

inferredcites →https://doi.org/10.1002/chir.530040513openalex-snapshot
FDA'S policy statement for the development of new stereoisomeric drugs
inferredcites →https://doi.org/10.1007/978-3-642-35099-3_86openalex-snapshot
Die International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
inferredcites →https://doi.org/10.1016/0306-3623(89)90037-2openalex-snapshot
Drug stereochemistry; analytical methods and pharmacology
inferredcites →https://doi.org/10.1016/j.drudis.2010.01.007openalex-snapshot
The strategy of enantiomer patents of drugs
inferredcites →https://doi.org/10.1021/cen-v083n025.p122openalex-snapshot
THALIDOMIDE
inferredcites →https://doi.org/10.1021/jm00316a057openalex-snapshot
Annual Reports in Medicinal Chemistry, 1965.
inferredcites →https://doi.org/10.1038/nbt.1936openalex-snapshot
Biosimilars—why terminology matters
inferredcites →https://doi.org/10.1038/nchem.750openalex-snapshot
Urban legends of chemistry
inferredcites →https://doi.org/10.1038/nrd2532openalex-snapshot
Follow-on biologics: data exclusivity and the balance between innovation and competition
inferredcites →https://doi.org/10.1038/nrd4239openalex-snapshot
2013 FDA drug approvals
inferredcites →https://doi.org/10.1038/nrd915openalex-snapshot
Putting chirality to work: the strategy of chiral switches
inferredcites →https://doi.org/10.1056/nejmp1311439openalex-snapshot
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
inferredcites →https://doi.org/10.1093/oso/9780192844477.001.0001openalex-snapshot
Overlapping Intellectual Property Rights
inferredcites →https://doi.org/10.1093/oxfordhb/9780199742998.013.0007openalex-snapshot
Patents and Regulatory Exclusivity
inferredcites →https://doi.org/10.1186/1472-6963-11-64openalex-snapshot
Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?
inferredcites →https://doi.org/10.1351/pac-rec-12-11-23openalex-snapshot
Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)
inferredcites →https://doi.org/10.2139/ssrn.5161089openalex-snapshot
Follow-On Biologics: The Law and Intellectual Property Issues
inferredcites →https://doi.org/10.4155/ppa.12.62openalex-snapshot
The patent-regulatory Regime in Canada
inferredcites →https://doi.org/10.4155/ppa.12.77openalex-snapshot
Biosimilars: Impact of Differences With Hatch–Waxman
inferredcites →https://doi.org/10.4155/ppa.14.6openalex-snapshot
Regulatory Exclusivity in the EU: the Impact of New Active Substance Status
inferredcites →https://doi.org/10.5639/gabij.2014.0401.012openalex-snapshot
Comparison of biosimilars guidelines
inferredcites →https://doi.org/10.5860/choice.41-2838openalex-snapshot
Protecting America's health: the FDA, business, and one hundred years of regulation

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

inferred← citeshttps://doi.org/10.2139/ssrn.4613631openalex-extracted
Determinants of R&D Project Abandonment: Evidence from the Pharmaceutical Industry
inferred← citeshttps://doi.org/10.1001/jamanetworkopen.2021.5731openalex-snapshot
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors
inferred← citeshttps://doi.org/10.1001/jamanetworkopen.2022.29231openalex-snapshot
Availability of New Medicines in the US and Germany From 2004 to 2018
inferred← citeshttps://doi.org/10.1002/9781118771723.ch0openalex-snapshot
Introduction
inferred← citeshttps://doi.org/10.1002/9783527693405.ch5openalex-snapshot
Financing Pharmaceutical Innovation
inferred← citeshttps://doi.org/10.1002/ange.201802797openalex-snapshot
CuH‐Catalyzed Asymmetric Hydroamidation of Vinylarenes
inferred← citeshttps://doi.org/10.1002/anie.201802797openalex-snapshot
CuH‐Catalyzed Asymmetric Hydroamidation of Vinylarenes
inferred← citeshttps://doi.org/10.1002/ardp.70272openalex-snapshot
USFDA‐Approved Small Molecules in the Year 2025: Medicinal Chemistry Strategies and Trends
inferred← citeshttps://doi.org/10.1002/chir.22501openalex-snapshot
Classroom Enters the Courtroom: Stereochemistry of SN1 and SN2 Reactions in Enantiomer Patent Litigations of the Antidepressant Escitalopram
inferred← citeshttps://doi.org/10.1002/cpt.70198openalex-snapshot
Assessing the “Drug Loss” and “Drug Lag” for Rare Diseases in China: A Comparative Analysis with the United States (2001–2024)
inferred← citeshttps://doi.org/10.1007/978-3-032-04060-2_5openalex-snapshot
Regulatory Exclusivities
inferred← citeshttps://doi.org/10.1007/978-3-319-12406-3_15openalex-snapshot
A Medicines Regulatory Perspective on Women’s Medicines
inferred← citeshttps://doi.org/10.1007/978-3-319-47377-2_6openalex-snapshot
Flow Cytometry and Immunophenotyping in Drug Development
inferred← citeshttps://doi.org/10.1007/978-3-319-56663-4_8openalex-snapshot
The Prospects of TRIPS-Plus Protection in Future Mega-Regionals
inferred← citeshttps://doi.org/10.1007/s00044-025-03470-wopenalex-snapshot
Designations of new biological drugs
inferred← citeshttps://doi.org/10.1007/s00044-026-03546-1openalex-snapshot
Drug law versus common parlance of medicinal chemists on “new chemical entity” of novel drug designations
inferred← citeshttps://doi.org/10.1007/s10822-017-0090-xopenalex-snapshot
Learning epistatic interactions from sequence-activity data to predict enantioselectivity
inferred← citeshttps://doi.org/10.1007/s11172-020-2762-2openalex-snapshot
Stable and reproducible supramolecular motif in the crystal structure of sulfonamides of the benzothiazine series fused to an epoxybornane moiety
inferred← citeshttps://doi.org/10.1007/s11192-020-03778-xopenalex-snapshot
Do current radical innovation measures actually measure radical drug innovation?
inferred← citeshttps://doi.org/10.1007/s43546-021-00163-5openalex-snapshot
Innovation crisis in the pharmaceutical industry? A survey
inferred← citeshttps://doi.org/10.1016/b978-0-443-15742-4.00103-4openalex-snapshot
Harnessing the Multitarget Approach for Green and Sustainable Drug Discovery
inferred← citeshttps://doi.org/10.1016/j.csbj.2016.09.002openalex-snapshot
The promises of quantitative systems pharmacology modelling for drug development
inferred← citeshttps://doi.org/10.1016/j.jpba.2017.07.008openalex-snapshot
The market of chiral drugs: Chiral switches versus de novo enantiomerically pure compounds
inferred← citeshttps://doi.org/10.1021/acs.jcim.7b00353openalex-snapshot
Effect of Binding on Enantioselectivity of Epoxide Hydrolase
inferred← citeshttps://doi.org/10.1021/acs.jcim.7b00401openalex-snapshot
Medicinal and Biological Chemistry (MBC) Library: An Efficient Source of New Hits
inferred← citeshttps://doi.org/10.1021/acs.jmedchem.3c02239openalex-snapshot
Chirality of New Drug Approvals (2013–2022): Trends and Perspectives
inferred← citeshttps://doi.org/10.1021/acs.joc.0c03017openalex-snapshot
Brønsted Acid Organocatalyzed Three-Component Hydroamidation Reactions of Vinyl Ethers
inferred← citeshttps://doi.org/10.1021/acsmedchemlett.0c00319openalex-snapshot
Structural Approach to Assessing the Innovativeness of New Drugs Finds Accelerating Rate of Innovation
inferred← citeshttps://doi.org/10.1021/acsmedchemlett.5c00320openalex-snapshot
The Importance of Correct New Drug Designations: New “Novel Drug Entity” Designations
inferred← citeshttps://doi.org/10.1021/acsptsci.2c00151openalex-snapshot
The Quest for Secondary Pharmaceuticals: Drug Repurposing/Chiral-Switches Combination Strategy
inferred← citeshttps://doi.org/10.1038/s41392-025-02267-yopenalex-snapshot
Current landscape of innovative drug development and regulatory support in China
inferred← citeshttps://doi.org/10.1039/c9dt02540eopenalex-snapshot
Copper hydride-mediated electrophilic amidation of vinylarenes with dioxazolones – a computational mechanistic study
inferred← citeshttps://doi.org/10.1039/d3dt04301kopenalex-snapshot
Copper-catalysed electrophilic carboamination of terminal alkynes with benzyne looked at through the computational lens
inferred← citeshttps://doi.org/10.1039/d3qo01176copenalex-snapshot
Enantioselective synthesis of axially chiral carbamates and amides with carbon dioxide via copper catalysis
inferred← citeshttps://doi.org/10.1080/10426507.2016.1146275openalex-snapshot
Syntheses and biological evaluation of phosphoryl-containing polyunsaturated fatty acid derivatives as hypolipidemic agents
inferred← citeshttps://doi.org/10.1080/14740338.2016.1248942openalex-snapshot
Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system
inferred← citeshttps://doi.org/10.1080/17568919.2026.2732255openalex-snapshot
A call for applications of drug repurposing/secondary pharmaceutical combinations strategy
inferred← citeshttps://doi.org/10.1093/bib/bbab159openalex-snapshot
Utilizing graph machine learning within drug discovery and development
inferred← citeshttps://doi.org/10.1126/scitranslmed.abd5524openalex-snapshot
Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers
inferred← citeshttps://doi.org/10.1167/iovs.62.3.17openalex-snapshot
NCX 667, a Novel Nitric Oxide Donor, Lowers Intraocular Pressure in Rabbits, Dogs, and Non-Human Primates and Enhances TGFβ2-Induced Outflow in HTM/HSC Constructs
inferred← citeshttps://doi.org/10.1177/27551938241247778openalex-snapshot
Capitalizing on Hope: Questionable Marketing Approval and Pricing of a New ALS Drug
inferred← citeshttps://doi.org/10.33612/diss.663386097openalex-snapshot
Therapeutic footprint
inferred← citeshttps://doi.org/10.3390/ph15020240openalex-snapshot
Chiral Switch: Between Therapeutical Benefit and Marketing Strategy
inferred← citeshttps://doi.org/10.3762/bjoc.21.12openalex-snapshot
Dioxazolones as electrophilic amide sources in copper-catalyzed and -mediated transformations
inferred← citeshttps://doi.org/10.3844/ajptsp.2022.37.47openalex-snapshot
Drug Repositioning in Response to COVID-19 and other Challenging Diseases
inferred← citeshttps://doi.org/10.4018/978-1-6684-6845-6.ch014openalex-snapshot
Reinventing Strategic Execution in the Pharmaceutical Industry
inferred← citeshttps://doi.org/10.48550/arxiv.2012.05716openalex-snapshot
Utilising Graph Machine Learning within Drug Discovery and Development
inferred← citeshttps://doi.org/10.5155/eurjchem.13.4.483-490.2312openalex-snapshot
Chiral metallic anticancer drugs: A brief-review
inferred← citeshttps://doi.org/10.5772/intechopen.74189openalex-snapshot
Application of Pharmacokinetics in Early Drug Development
inferred← citeshttps://doi.org/10.7324/japs.2018.8822openalex-snapshot
Drug Repositioning: Concept, Classification, Methodology, and Importance in Rare/Orphans and Neglected Diseases
Editorial review for independent work. ICSAC — the Institute for Complexity Science and Advanced Computing — runs a structured editorial panel for researchers publishing outside journals, and publishes on CiteStamp rails. Submission is free and goes through ORCID: icsacinstitute.org/submit.