{"record_type":"pith_number_record","schema_url":"https://pith.science/schemas/pith-number/v1.json","pith_number":"pith:2016:UGUZ5LSAU647CIJCPFLV7SOM2G","short_pith_number":"pith:UGUZ5LSA","schema_version":"1.0","canonical_sha256":"a1a99eae40a7b9f1212279575fc9ccd1bafb6fc4bbbe45f9490766c273743d48","source":{"kind":"arxiv","id":"1607.02283","version":2},"attestation_state":"computed","paper":{"title":"Adaptive seamless design for establishing pharmacokinetics and efficacy equivalence in developing biosimilars","license":"http://creativecommons.org/publicdomain/zero/1.0/","headline":"","cross_cats":[],"primary_cat":"stat.AP","authors_text":"Chikuma Hamada, Ryuji Uozumi","submitted_at":"2016-07-08T09:30:04Z","abstract_excerpt":"Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate the equivalence of pharmacokinetics (PK) and clinical efficacy. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated clinical trials to include efficacy measures as the primary endpoint. In this study, we propose an adaptive seamless PK and efficacy design with the frameworks to remedy the risk of misspecification of b"},"verification_status":{"content_addressed":true,"pith_receipt":true,"author_attested":false,"weak_author_claims":0,"strong_author_claims":0,"externally_anchored":false,"storage_verified":false,"citation_signatures":0,"replication_records":0,"graph_snapshot":true,"references_resolved":false,"formal_links_present":false},"canonical_record":{"source":{"id":"1607.02283","kind":"arxiv","version":2},"metadata":{"license":"http://creativecommons.org/publicdomain/zero/1.0/","primary_cat":"stat.AP","submitted_at":"2016-07-08T09:30:04Z","cross_cats_sorted":[],"title_canon_sha256":"005d6096c4d1b94a9e98cb80850180c24333165fc33b9cfd24e76b906c26c9ff","abstract_canon_sha256":"3632f36716a8c898be924c23bf436773c2119e98e6499731ed941270f3e2948e"},"schema_version":"1.0"},"receipt":{"kind":"pith_receipt","key_id":"pith-v1-2026-05","algorithm":"ed25519","signed_at":"2026-05-18T00:44:33.786570Z","signature_b64":"ANRxT1UiOg/Fwqp+tP2QKNKr8Pu6B0k+AEsHFE5Mg1LUH9ZKgBMfo/759ZyuNrE9CTfm8n16pUIIpk3rvHcUDQ==","signed_message":"canonical_sha256_bytes","builder_version":"pith-number-builder-2026-05-17-v1","receipt_version":"0.3","canonical_sha256":"a1a99eae40a7b9f1212279575fc9ccd1bafb6fc4bbbe45f9490766c273743d48","last_reissued_at":"2026-05-18T00:44:33.786117Z","signature_status":"signed_v1","first_computed_at":"2026-05-18T00:44:33.786117Z","public_key_fingerprint":"8d4b5ee74e4693bcd1df2446408b0d54"},"graph_snapshot":{"paper":{"title":"Adaptive seamless design for establishing pharmacokinetics and efficacy equivalence in developing biosimilars","license":"http://creativecommons.org/publicdomain/zero/1.0/","headline":"","cross_cats":[],"primary_cat":"stat.AP","authors_text":"Chikuma Hamada, Ryuji Uozumi","submitted_at":"2016-07-08T09:30:04Z","abstract_excerpt":"Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate the equivalence of pharmacokinetics (PK) and clinical efficacy. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated clinical trials to include efficacy measures as the primary endpoint. In this study, we propose an adaptive seamless PK and efficacy design with the frameworks to remedy the risk of misspecification of b"},"claims":{"count":0,"items":[],"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"source":{"id":"1607.02283","kind":"arxiv","version":2},"verdict":{"id":null,"model_set":{},"created_at":null,"strongest_claim":"","one_line_summary":"","pipeline_version":null,"weakest_assumption":"","pith_extraction_headline":""},"references":{"count":0,"sample":[],"resolved_work":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57","internal_anchors":0},"formal_canon":{"evidence_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"author_claims":{"count":0,"strong_count":0,"snapshot_sha256":"258153158e38e3291e3d48162225fcdb2d5a3ed65a07baac614ab91432fd4f57"},"builder_version":"pith-number-builder-2026-05-17-v1"},"aliases":[{"alias_kind":"arxiv","alias_value":"1607.02283","created_at":"2026-05-18T00:44:33.786194+00:00"},{"alias_kind":"arxiv_version","alias_value":"1607.02283v2","created_at":"2026-05-18T00:44:33.786194+00:00"},{"alias_kind":"doi","alias_value":"10.48550/arxiv.1607.02283","created_at":"2026-05-18T00:44:33.786194+00:00"},{"alias_kind":"pith_short_12","alias_value":"UGUZ5LSAU647","created_at":"2026-05-18T12:30:46.583412+00:00"},{"alias_kind":"pith_short_16","alias_value":"UGUZ5LSAU647CIJC","created_at":"2026-05-18T12:30:46.583412+00:00"},{"alias_kind":"pith_short_8","alias_value":"UGUZ5LSA","created_at":"2026-05-18T12:30:46.583412+00:00"}],"events":[],"event_summary":{},"paper_claims":[],"inbound_citations":{"count":0,"internal_anchor_count":0,"sample":[]},"formal_canon":{"evidence_count":0,"sample":[],"anchors":[]},"links":{"html":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G","json":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G.json","graph_json":"https://pith.science/api/pith-number/UGUZ5LSAU647CIJCPFLV7SOM2G/graph.json","events_json":"https://pith.science/api/pith-number/UGUZ5LSAU647CIJCPFLV7SOM2G/events.json","paper":"https://pith.science/paper/UGUZ5LSA"},"agent_actions":{"view_html":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G","download_json":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G.json","view_paper":"https://pith.science/paper/UGUZ5LSA","resolve_alias":"https://pith.science/api/pith-number/resolve?arxiv=1607.02283&json=true","fetch_graph":"https://pith.science/api/pith-number/UGUZ5LSAU647CIJCPFLV7SOM2G/graph.json","fetch_events":"https://pith.science/api/pith-number/UGUZ5LSAU647CIJCPFLV7SOM2G/events.json","actions":{"anchor_timestamp":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G/action/timestamp_anchor","attest_storage":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G/action/storage_attestation","attest_author":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G/action/author_attestation","sign_citation":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G/action/citation_signature","submit_replication":"https://pith.science/pith/UGUZ5LSAU647CIJCPFLV7SOM2G/action/replication_record"}},"created_at":"2026-05-18T00:44:33.786194+00:00","updated_at":"2026-05-18T00:44:33.786194+00:00"}