Role:
TP
TechPranee PV
PharmaCorp Ltd
Operations/Search Strategy Builder

Search Strategy Builder

Author, validate, and govern Boolean search strategies for literature surveillance.

Draftv3.1 (draft)

Product Profile

Product Name
Cardiomab
Active Substance (INN)
cardiomabumab
Search Frequency
Weekly
Brand Names
CardiomabCardiomab prefilled penCardioMab SC
Development Codes
TPC-401PV-CDM-001RT-2024-077
Salt Variants
cardiomabumab acetatecardiomabumab sodium
Indications
Hypercholesterolemia (familial heterozygous) · Atherosclerotic cardiovascular disease prevention · Statin intolerance adjunct therapy
Monitored Countries
USEUJP
Configured Sources
PubMedEmbaseLocal RepositoryManual Submissions
Assigned Reviewer
Dr. Elena Vasquez
Backup Reviewer
Dr. Marcus Lindqvist

Search-Term Sections

Editable tag lists grouped by term category.

34 terms · est. 412 articles/cycle

Substance Synonyms

4 terms

Chemical entity and INN variants for the active substance.

cardiomabumabanti-PCSK9 monoclonal antibodyPCSK9icardiomab
AIAI detected the INN is current; consider adding the USAN and former code names.

Brand Names

3 terms

Marketed trade names across all monitored regions.

CardiomabCardiomab prefilled penCardioMab SC

Scientific Names

3 terms

Full scientific / molecular descriptors.

cardiomabumab acetatehumanized IgG1 anti-PCSK9fully human monoclonal antibody PCSK9

Misspellings & Variants

4 terms

Common spelling variants captured from retrieval audit.

cardiomabumbcardiomabumumabcardio mabkardiomab

Combination / Co-administration Terms

3 terms

Concomitant therapy combinations relevant to label.

cardiomabumab AND statincardiomabumab AND ezetimibecardiomabumab AND PCSK9 inhibitor combination

Adverse Event Terms

6 terms

MedDRA-aligned preferred terms of safety interest.

myalgiarhabdomyolysisinjection-site reactionhypersensitivityneurocognitive impairmenthepatic enzyme increased

Special Situation Terms

6 terms

Pregnancy, paediatric, off-label, medication error, misuse.

pregnancy exposurepaediatric useoff-label usemedication errordrug misuselack of efficacy

Exclusion Terms

5 terms

Terms to exclude from the Boolean query (noise reduction).

animal modelin vitropreclinicalhealthy volunteerpharmacokinetics only
AI

Search Strategy Copilot

Missing Synonyms
Missing synonym: “alirocumab-like” comparator

Cardiomabumab is frequently discussed alongside the PCSK9 inhibitor class (alirocumab, evolocumab). Adding “PCSK9 inhibitor class” captures comparative-safety publications that name Cardiomab only by class.

Adds an estimated 18–26 articles per search cycle.
Alternative Terminology
Alternative terminology: “proprotein convertase subtilisin/kexin type 9”

The full enzyme name “proprotein convertase subtilisin/kexin type 9” appears in 41 indexed abstracts that do not use “PCSK9” or “cardiomabumab”.

+12 articles; improves recall in Embase Emtree mapping.
Boolean Improvement
Boolean improvement: group AE terms with OR proximity

Current query ANDs adverse-event terms, dropping articles where the AE appears only in the full text. Recommend: (cardiomabumab OR brand OR code) AND (ae1 OR ae2 …) within 5 words, OR abstract-anchored.

Recall +6%, precision −1.4% (net gain).
Over-Restrictive
Over-restrictive term: “healthy volunteer” exclusion

Excluding “healthy volunteer” removes Phase I safety reports that are in-scope per the RMP. Recommend narrowing to “healthy volunteer” NOT (“adverse” OR “reaction”).

Recovers 4 in-scope Phase I articles.
Search Gap
Search gap: no Japanese-language term set

Cardiomab is marketed in Japan but the strategy has no Japanese-language variants (心臓マブ, カルジオマブ). Embase JP and J-MEDLINE will under-return.

Estimated 30–40 JP-region articles missed per quarter.
Volume Change
Estimated volume change if all suggestions accepted

Accepting suggestions S1–S5 increases expected retrieval by ~62 articles/cycle (+15%). Estimated screening burden: +18 min human review / cycle.

Volume Δ: +15.2% (high-confidence estimate).
0 of 6 suggestions actioned

Query Preview

Readable Boolean
[PubMed / MeSH]
("cardiomabumab" OR "anti-PCSK9 monoclonal antibody" OR "PCSK9i" OR "cardiomab" OR "Cardiomab" OR "Cardiomab prefilled pen" OR "CardioMab SC" OR "cardiomabumab acetate" OR "humanized IgG1 anti-PCSK9" OR "fully human monoclonal antibody PCSK9") AND ("myalgia" OR "rhabdomyolysis" OR "injection-site reaction" OR "hypersensitivity" OR "neurocognitive impairment" OR "hepatic enzyme increased") OR ("pregnancy exposure" OR "paediatric use" OR "off-label use" OR "medication error" OR "drug misuse" OR "lack of efficacy") OR (cardiomabumab AND statin OR cardiomabumab AND ezetimibe OR cardiomabumab AND PCSK9 inhibitor combination) NOT ("animal model" OR "in vitro" OR "preclinical" OR "healthy volunteer" OR "pharmacokinetics only")
Raw Database Query
https://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&term=(cardiomabumab[TIAB]+OR+anti-PCSK9%20monoclonal%20antibody[TIAB]+OR+PCSK9i[TIAB]+OR+cardiomab[TIAB]+OR+Cardiomab[TIAB]+OR+Cardiomab%20prefilled%20pen[TIAB]+OR+CardioMab%20SC[TIAB]+OR+cardiomabumab%20acetate[TIAB]+OR+humanized%20IgG1%20anti-PCSK9[TIAB]+OR+fully%20human%20monoclonal%20antibody%20PCSK9[TIAB])+AND+(myalgia[TIAB]+OR+rhabdomyolysis[TIAB]+OR+injection-site%20reaction[TIAB]+OR+hypersensitivity[TIAB]+OR+neurocognitive%20impairment[TIAB]+OR+hepatic%20enzyme%20increased[TIAB])+NOT+(animal%20model[TIAB]+OR+in%20vitro[TIAB]+OR+preclinical[TIAB]+OR+healthy%20volunteer[TIAB]+OR+pharmacokinetics%20only[TIAB])&retmax=200&sort=date
Est. 412 articles/cycle

Approval Workflow & Version Control

Controlled lifecycle: Draft → Under Review → Approved → Superseded. All transitions are auditable.

Current state:Draft
1Draft
2Under Review
3Approved
4Superseded
Version (draft)
v3.1
Author
Dr. Elena Vasquez
Reviewer
— (not assigned)
Effective Date
— (pending approval)
Approval Timestamp
Term Count
34
Est. Articles/Cycle
412
Reason for Change
— (not yet provided)

Version History

VersionStateAuthorReviewerEffectiveTermsEst. Vol
v3.0ApprovedDr. Elena VasquezDr. Sven Eriksson2026-06-0138412
v2.1SupersededDr. Marcus LindqvistDr. Elena Vasquez2026-02-1531367
v2.0SupersededDr. Elena VasquezDr. Sven Eriksson2025-11-0128351
v3.1 (draft)DraftDr. Elena Vasquez34412
Reason for Change — v3.0

Added special-situation term set; expanded AE terms with neurocognitive and hepatic PTs per RMP v2.3 update.

Version Comparison

Term count3134 (+3 terms)
Est. articles/cycle367412 (+45 art.)
+3 terms, +45 articles — broader recall vs v2.1.
⚠️The AI Search Strategy Copilot provides retrieval-optimization suggestions. All search-strategy changes must be reviewed and approved by a qualified PV reviewer before being used in live surveillance. This prototype is not a validated safety database.