{"doi":"10.1080/10601330701683412","title":"Exploratory Investigational New Drug (IND) Studies in Humans","abstract":null,"journal":"Clinical Research and Regulatory Affairs","year":2007,"id":604586,"datarank":0.19166579781963727,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.08769372073564545,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.08769372073564545,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":1,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1551262,"name":"David Jacobson-Kram","orcid":null,"position":1,"is_corresponding":false},{"id":1551261,"name":"Vijay Tammara","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Exploratory Investigational New Drug (IND) Studies in Humans","abstract":"In recent years drug development costs have escalated despite the fact that new technology is evolving and the development process has accelerated. This is due in part to the extremely high failure rate of drugs at early phases of drug development. Efforts are underway within the pharmaceutical industry to shift this attrition rate to early stages of drug development rather than at late stages. To this end, the exploratory IND approach is considered as one of the tools in a new drug development “tool box,” to distinguish earlier in the process those candidates that hold promise from those that do not. The phrase exploratory IND study is intended to describe a clinical trial that is conducted early in phase 1, involves very limited human exposure, has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies), and is NOT intended to establish a maximally tolerated dose (MTD). In this article, authors attempt to summarize the goals of eIND, a brief description of eIND requirements, and limitations of an eIND.","is_dataset_classified":null,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"21097893","pmcid":null,"openalex_id":"https://openalex.org/W2019434790","authors":[],"funders":[],"total_grants":0,"fwci":0.1105,"citation_percentile":0.50865052,"influential_citations":0,"citation_trend":[],"oa_status":"closed","license":null,"oa_locations":[{"url":"http://www.tandfonline.com/doi/pdf/10.1080/10601330701683412","host_type":"publisher"},{"url":"https://doi.org/10.1080/10601330701683412","host_type":"journal"}],"fields_of_study":["Biosimilars and Bioanalytical Methods","Pharmaceutical studies and practices","Pharmaceutical Economics and Policy"],"mesh_terms":[],"keywords":["Investigational Drugs","Drug development","MicroDose","Medicine","Risk analysis (engineering)","Drug","Clinical trial","Computer science","Medical physics","Intensive care medicine","Pharmacology","Pathology"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-30T00:27:54.518209Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}