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Record W2385059186

New prospect on research and development of Chinese Materia Medica and phytomedicines in global

2011· article· en· W2385059186 on OpenAlexaboutno aff
He Sun

Bibliographic record

VenueDrug Evaluation Research · 2011
Typearticle
Languageen
FieldMedicine
TopicTraditional Chinese Medicine Analysis
Canadian institutionsnot available
Fundersnot available
KeywordsPhytomedicineMateria medicaMedicineTraditional medicinePillBusinessAlternative medicinePharmacology
DOInot available

Abstract

fetched live from OpenAlex

With the global changes of the disease spectrum and the needs of health,it is now the knotty problem and huge challenge for the pharmaceutical industries to ensure the continuous RD and the sustainability of market for the innovative drugs worldwide.In recent years,US,EP,and Canada issued the new regulations on the phytomedicine,which not only means they will have the equal status compared to the non-botanical drugs,but also more flexibility on the regulations of the approval and launch on the market.In this paper,the different regulations of phytomedicine and botanical products in the US,EP and Canada are introduced,the process of the series of RD of Dantonic(Fufang Danshen Dripping Pill,the 1st CMM compound drug with the FDA IND approval) and its global Phase II clinical trial since 1997 reviewed,the experiences on the regulatory conversation with FDA summarized,and the new prospect on the future global RD of chinese materia medica put forward.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.010
metaresearch head score (Gemma)0.002
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesInsufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.071
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0100.002
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0010.002
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.247
GPT teacher head0.492
Teacher spread0.245 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations1
Published2011
Admission routes1
Has abstractyes

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