Model: philipk22/ind312-ft-v0
Author: philipk22
Pipeline: sentence-similarity
Library: sentence-transformers
Tags: sentence-transformers, safetensors, bert, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:798, loss:MatryoshkaLoss, loss:MultipleNegativesRankingLoss, arxiv:1908.10084, arxiv:2205.13147, arxiv:1705.00652, base_model:Snowflake/snowflake-arctic-embed-m, base_model:finetune:Snowflake/snowflake-arctic-embed-m, model-index, text-embeddings-inference, endpoints_compatible, region:us
Base models (finetune): id: Snowflake/snowflake-arctic-embed-m
Card metadata: tags: sentence-transformers, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:798, loss:MatryoshkaLoss, loss:MultipleNegativesRankingLoss
base_model: Snowflake/snowflake-arctic-embed-m
widget: source_sentence: What is the definition of a sponsor-investigator according to the provided context?
sentences: § 312.47 Meetings.
(a) General. Meetings between a sponsor and the agency are frequently useful in resolving questions and
issues raised during the course of a clinical investigation. FDA encourages such meetings to the extent
that they aid in the evaluation of the drug and in the solution of scientific problems concerning the drug, to
the extent that FDA's resources permit. The general principle underlying the conduct of such meetings is, employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and
the employees are investigators.
Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose
immediate direction the investigational drug is administered or dispensed. The term does not include any
person other than an individual. The requirements applicable to a sponsor-investigator under this part, practice regulations in part 58, or, if the study was not conducted in compliance with those
regulations, a brief statement of the reason for the noncompliance.
(9) Previous human experience with the investigational drug. A summary of previous human experience
known to the applicant, if any, with the investigational drug. The information is required to include
the following:
(i) If the investigational drug has been investigated or marketed previously, either in the United, source_sentence: What is the primary purpose of Phase 1 studies in drug development?
sentences: § 312.53 Selecting investigators and monitors.
§ 312.54 Emergency research under § 50.24 of this chapter.
§ 312.55 Informing investigators.
This content is from the eCFR and is authoritative but unofficial.
21 CFR Part 312 (up to date as of 1/23/2025)
Investigational New Drug Application 21 CFR Part 312 (Jan. 23, 2025)
21 CFR Part 312 (Jan. 23, 2025) (enhanced display) page 1 of 54, relevant to the safety of the drug as are required under § 312.32. The sponsor shall make annual reports
on the progress of the investigation in accordance with § 312.33.
(d) A sponsor who determines that its investigational drug presents an unreasonable and significant risk to
subjects shall discontinue those investigations that present the risk, notify FDA, all institutional review
boards, and all investigators who have at any time participated in the investigation of the discontinuance,, are typically closely monitored and may be conducted in patients or normal volunteer subjects.
These studies are designed to determine the metabolism and pharmacologic actions of the drug in
humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on
effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and
pharmacological effects should be obtained to permit the design of well-controlled, scientifically, source_sentence: What is the required format for numbering submissions related to the investigation?
sentences: using a single, three-digit serial number. The initial IND is required to be numbered 000; each subsequent
submission (e.g., amendment, report, or correspondence) is required to be numbered chronologically in
sequence.
(f) Identification of exception from informed consent. If the investigation involves an exception from informed
consent under § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the, response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed
until the sponsor has been notified by FDA that the hold has been lifted.
(f) Appeal. If the sponsor disagrees with the reasons cited for the clinical hold, the sponsor may request
reconsideration of the decision in accordance with § 312.48.
(g) Conversion of IND on clinical hold to inactive status. If all investigations covered by an IND remain on, investigator, the sponsor of any investigation in which the investigator has been named as a participant,
and the reviewing institutional review boards (IRBs) that the investigator is not eligible to receive test
articles under this part. The notification to the investigator, sponsor, and IRBs will provide a statement of
21 CFR Part 312 (up to date as of 1/23/2025)
Investigational New Drug Application 21 CFR 312.66
21 CFR 312.70(b) (enhanced display) page 37 of 54, source_sentence: What are the regions mentioned in the context where drugs can be exported?
sentences: Africa, or to any country in the European Union or the European Economic Area, and complies with
the laws of the country to which it is being exported, the applicable provisions of section 802(c), (f),
and (g) of the act, and § 1.101 of this chapter. Drugs exported under this paragraph that are not the
subject of an IND are exempt from the label requirement in § 312.6(a); or
(4) Except as provided in paragraph (b)(5) of this section, the person exporting the drug sends an email, before its implementation. Protocol amendments to add a new investigator or to provide additional
information about investigators may be grouped and submitted at 30-day intervals. When several
submissions of new protocols or protocol changes are anticipated during a short period, the sponsor is
encouraged, to the extent feasible, to include these all in a single submission.
21 CFR Part 312 (up to date as of 1/23/2025)
Investigational New Drug Application 21 CFR 312.30(b)(2)(i)(b), that apply to specific types of expanded access are described in §§ 312.310 through 312.320.
(a) Scope. This subpart contains the requirements for the use of investigational new drugs and approved
drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary
purpose is to diagnose, monitor, or treat a patient's disease or condition. The aim of this subpart is to, source_sentence: What regulatory framework does 21 CFR Part 312 pertain to as of January 23, 2025?
sentences: risk-benefit judgment in making the final decision on approvability. As part of this evaluation, consistent
with the statement of purpose in § 312.80, FDA will consider whether the benefits of the drug outweigh
the known and potential risks of the drug and the need to answer remaining questions about risks and
benefits of the drug, taking into consideration the severity of the disease and the absence of satisfactory
alternative therapy., provide for disposition of the unused supplies of the drug under § 312.59.
(b) Case histories. An investigator is required to prepare and maintain adequate and accurate case histories
that record all observations and other data pertinent to the investigation on each individual administered
the investigational drug or employed as a control in the investigation. Case histories include the case
report forms and supporting data including, for example, signed and dated consent forms and medical, § 312.315 Intermediate-size patient populations.
21 CFR Part 312 (up to date as of 1/23/2025)
Investigational New Drug Application 21 CFR Part 312 (Jan. 23, 2025)
21 CFR Part 312 (Jan. 23, 2025) (enhanced display) page 2 of 54
pipeline_tag: sentence-similarity
library_name: sentence-transformers
metrics: cosine_accuracy@1, cosine_accuracy@3, cosine_accuracy@5, cosine_accuracy@10, cosine_precision@1, cosine_precision@3, cosine_precision@5, cosine_precision@10, cosine_recall@1, cosine_recall@3, cosine_recall@5, cosine_recall@10, cosine_ndcg@10, cosine_mrr@10, cosine_map@100
model-index: name: SentenceTransformer based on Snowflake/snowflake-arctic-embed-m
results: task: type: information-retrieval
name: Information Retrieval
dataset: name: Unknown
type: unknown
metrics: type: cosine_accuracy@1
value: 0.92
name: Cosine Accuracy@1
verified: no, type: cosine_accuracy@3
value: 0.99
name: Cosine Accuracy@3
verified: no, type: cosine_accuracy@5
value: 0.99
name: Cosine Accuracy@5
verified: no, type: cosine_accuracy@10
value: 1
name: Cosine Accuracy@10
verified: no, type: cosine_precision@1
value: 0.92
name: Cosine Precision@1
verified: no, type: cosine_precision@3
value: 0.33000000000000007
name: Cosine Precision@3
verified: no, type: cosine_precision@5
value: 0.19799999999999998
name: Cosine Precision@5
verified: no, type: cosine_precision@10
value: 0.09999999999999998
name: Cosine Precision@10
verified: no, type: cosine_recall@1
value: 0.92
name: Cosine Recall@1
verified: no, type: cosine_recall@3
value: 0.99
name: Cosine Recall@3
verified: no, type: cosine_recall@5
value: 0.99
name: Cosine Recall@5
verified: no, type: cosine_recall@10
value: 1
name: Cosine Recall@10
verified: no, type: cosine_ndcg@10
value: 0.9637992620139386
name: Cosine Ndcg@10
verified: no, type: cosine_mrr@10
value: 0.9516666666666665
name: Cosine Mrr@10
verified: no, type: cosine_map@100
value: 0.9516666666666667
name: Cosine Map@100
verified: no
Likes: 0 | All-time downloads: 11
Created: 2025-02-22 19:50:19