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11 merged results for "Biosimilars and Bioanalytical Methods"

Partial results: at least one source did not answer. Available results are shown rather than treating an upstream outage as zero matches.

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  1. Pharmacokinetic and Pharmacodynamic Bio-Similarity of ADL-018 to Innovator Omalizumab: A Randomized Study in Healthy Adults.

    Soitawala S, Prajapati H, Mehta H, Singh PK. · 2026 · Clin Pharmacol Drug Dev

    limited evidence Transparent signal score 43/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1002/cpdd.70098

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    • cautionDOI registered: No matching Crossref record was present in this response. Source: Crossref; license: CC0 metadata
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    • not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
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    • not scoredOpen access status: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  2. FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease.

    Delvadia PR, Nookala AR, Gottipati G, Sabarinath S · 2026 · J Clin Pharmacol

    limited evidence Transparent signal score 43/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1002/jcph.70257

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    • not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
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    • not scoredOpen access status: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  3. Biopharmaceutical analysis - current analytical challenges, limitations, and perspectives.

    Cunha DR, Quinaz MB, Segundo MA. · 2026 · Anal Bioanal Chem

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1007/s00216-025-06036-2

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    • not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  4. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin<sup>®</sup> and US-Avastin<sup>®</sup> in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer.

    Kim T, Kim H, Lee H, Ahn K · 2026 · BioDrugs

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1007/s40259-026-00800-1

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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  5. Inhibition of RANKL is critical for accurate assessment of anti-drug antibody incidence to denosumab in clinical studies.

    Miller MJ, Kroenke MA, Barger T, Manning MS · 2025 · J Immunol Methods

    limited evidence Transparent signal score 43/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1016/j.jim.2025.113864

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    • not scoredOpen access status: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  6. The changes necessary in the assessment of immunogenicity for the development of Biosimilars.

    Poetzl J. · 2025 · Bioanalysis

    limited evidence Transparent signal score 43/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1080/17576180.2025.2461373

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    • cautionDOI registered: No matching Crossref record was present in this response. Source: Crossref; license: CC0 metadata
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    • not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
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    • not scoredOpen access status: Not checked or no result supplied; no credibility inference made. Source: No authority result supplied; license: Unknown
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  7. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars.

    Krishnan A, Bp S, Mehta G, Ramaswamy S · 2026 · Bioanalysis

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1080/17576180.2026.2715917

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    • cautionDOI registered: No matching Crossref record was present in this response. Source: Crossref; license: CC0 metadata
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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  8. Advancing PEGylated Drug Evaluation: A Novel Approach to Pegfilgrastim Pharmacokinetic Assessment.

    Svyatova E, Shi D, Shah A, Howard KE. · 2026 · Clin Transl Sci

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1111/cts.70588

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    • not scoredRetraction Watch retraction: No retraction notice matched this DOI in the deployed snapshot. No matching event found; coverage may be incomplete. Source: Retraction Watch; license: CC BY 4.0
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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  9. Anti-PEG Antibodies From mRNA COVID-19 Vaccines Affect In Vitro Measurements of Pegylated Drug Levels.

    Svyatova EA, Liu Z, Becker RE, Sung JM · 2026 · Clin Transl Sci

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.1111/cts.70667

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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  10. A Double-blind Randomized Comparative Phase I Study to Assess Biosimilarity and Immunogenicity of "Trastuzumab" (LLC "Mabscale", Russia) and Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in Healthy Volunteers

    M. A. Kolganova, E. E. Beketov, V. V. Pisarev, A. V. Ivanov · 2023 · Разработка и регистрация лекарственных средств

    uncertain Transparent signal score 53/100 · policy 1.0.0

    Found in doaj · DOI 10.33380/2305-2066-2023-12-3-240-249

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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
  11. Impact of Aggregation on the Immunogenicity of Therapeutic Recombinant Biological Products.

    Chen X, Guo S, Feng X, Zhou Z · 2026 · Pharmaceuticals (Basel)

    limited evidence Transparent signal score 45/100 · policy 1.0.0

    Found in europe-pmc · DOI 10.3390/ph19101604

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    • supportingOpen access status: Normalized open-access status: open. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer
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    • cautionMetadata completeness: 5 of 6 scored descriptive metadata groups are present; missing fields increase uncertainty. Source: Normalized work metadata; license: Caller-provided; provenance license not supplied to scorer