治験薬

関: IND、investigational agent、investigational new drug

WordNet

use recreational drugs (同)do drugs
administer a drug to; "They drugged the kidnapped tourist" (同)dose
a substance that is used as a medicine or narcotic
the work of inquiring into something thoroughly and systematically (同)investigating

PrepTutorEJDIC

『薬』,薬品,薬剤 / 『麻薬』,麻酔剤 / 〈人〉‘に'薬(特に麻酔剤)を与える / 〈飲食物〉‘に'(麻酔薬・毒薬などの)薬を混ぜる
(…の)『調査』,取り調べ,研究《+『of』(『into』)+『名』》

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/08/04 18:56:42」(JST)

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The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial. Regulations are primarily at 21 C.F.R. 312.

Criteria for application

An IND is required for a clinical study if it is intended to support a:

New indication
Change in the approved route of administration or dosage level
Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised)
Significant change in the promotion of an approved drug

Application contents

The IND application must contain information in three broad areas:

Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Chemistry and Manufacturing Information – Information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. The chemical stability and activity of the product must also have been tested. This information is assessed to ensure that the company can adequately produce and supply consistent and active batches of the drug.
Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Information on the qualifications of clinical investigators—professionals (generally physicians) who oversee the administration of the experimental compound—to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.

An IND must also include an Investigator's Brochure which is a document intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients who will be enrolled.

IND types

Timeline comparing 'standard' drug approval procedure to several exceptional cases

There are three IND types:

An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND.
Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.^[1]

Additional regulations

Experimental drugs under an IND must be labeled, "Caution: New Drug – Limited by Federal (or United States) law to investigational use.

Noteworthy examples

The FDA runs a medical marijuana IND program (the Compassionate Investigational New Drug program). It stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President George H.W. Bush administration's desire to "get tough on crime and drugs." As of 2011, four patients continue to receive cannabis from the government under the program.^[2]

References

^ "Investigational New Drug (IND) Application". FDA. Retrieved 7 March 2013.
^ AP (September 27, 2011). Associated Press News http://www.cbsnews.com/news/4-americans-get-medical-pot-from-the-feds/. Missing or empty |title= (help)

Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration.
ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance. BROKEN LINK
Troetel, W.M.: Achieving a Successful US IND Filing (1) The Regulatory Affairs Journal. 6: 22–28, January 1995.
Troetel, W.M.: Achieving a Successful US IND Filing (2) The Regulatory Affairs Journal. 6: 104–108, February 1995.

External links

IND Forms and Instructions from the US Food and Drug Administration

UpToDate Contents

全文を閲覧するには購読必要です。 To read the full text you will need to subscribe.

1. 薬物アレルギー患者へのアプローチ an approach to the patient with drug allergy
2. 抗マラリア剤：概要 antimalarial drugs an overview
3. 成人における薬物中毒への一般的アプローチ general approach to drug poisoning in adults
4. 小児における季節性インフルエンザ：予防および治療のための抗ウイルス剤 seasonal influenza in children prevention and treatment with antiviral drugs
5. リウマチ性疾患における免疫抑制剤および疾患修飾剤の使用の概要 overview of the use of immunosuppressive and disease modifying drugs in the rheumatic diseases

English Journal

ALK inhibitor crizotinib combined with intrathecal methotrexate treatment for non-small cell lung cancer with leptomeningeal carcinomatosis.

Ahn HK, Han B, Lee SJ, Lim T, Sun JM, Ahn JS, Ahn MJ, Park K.SourceDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Lung cancer (Amsterdam, Netherlands).Lung Cancer.2012 May;76(2):253-4. Epub 2012 Mar 3.
Anaplastic lymphoma kinase (ALK) inhibitor has shown dramatic efficacy in non-small cell lung cancer (NSCLC) patients harboring ALK rearrangements in phase I trial. Herein we report two cases of NSCLC patients with leptomeningeal carcinomatosis (LM), treated with ALK inhibitor under emergent use of
PMID 22385925

Challenge of pediatric oncology in Africa.

Hadley LG, Rouma BS, Saad-Eldin Y.SourceDepartment of Paediatric Surgery, University of KwaZulu-Natal, Durban, South Africa.
Seminars in pediatric surgery.Semin Pediatr Surg.2012 May;21(2):136-41.
The care of children with malignant solid tumors in sub-Saharan Africa is compromised by resource deficiencies that range from inadequate healthcare budgets and a paucity of appropriately trained personnel, to scarce laboratory facilities and inconsistent drug supplies. Patients face difficulties ac
PMID 22475119

Japanese Journal

The Effect of Zinc Agent in 219 Patients with Zinc Deficiency-inductive/Idiopathic Taste Disorder: A Placebo Controlled Randomized Study

池田稔,黒野祐一,井之口昭,武田憲昭,愛場庸雅,野村泰之,阪上雅史
Nippon Jibiinkoka Gakkai Kaiho 116(1), 17-26, 2013
… As a result, the zinc-treated arm experienced a statistically significant improvement against the placebo-treated arm in the perceptible threshold scores of the filter-paper disk method 8 weeks after the administration of the investigational drug. … Moreover, the effect lasted for 4 weeks after discontinuation of the drug. …
NAID 130003372887

『医薬品研究開発の生産性向上へのチャレンジ』　トランスレーショナルリサーチにおけるファーマコゲノミクス（ゲノム薬理学）の役割

劉世玉
日本薬理学雑誌 141(3), 131-135, 2013
… にあり，医薬品１剤あたりの開発コストの上昇，研究開発の生産性低下が問題となっている．研究開発の生産性を高めるため，様々な取り組みが行われており，Exploratory IND（探索的IND，IND：investigational new drug），バイオマーカーの利用，PGx（pharmacogenomics：ファーマコゲノミクス，またはゲノム薬理学）の導入やイメージング技術などを医薬品開発の加速ツールとするトランスレーショナルリサーチ …
NAID 130003362539

液体クロマトグラフィーによる医薬品分析における分析法バリデーション

数崎正人,上田伸二,竹内尚人,大神泰孝
Chromatography : journal of separation and detection sciences = クロマトグラフィー : 分離・検出科学 33(2), 65-73, 2012-08-10
NAID 10031002895

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リンク元	「IND」「治験薬」「investigational agent」「investigational new drug」
関連記事	「investigational」「investigation」「drug」

「IND」

　　[★]

治験薬 investigational new drug、investigational agent、investigational drug、、Investigational New Drug application
インドメタシン

「治験薬」

　　[★]

英: investigational drug、investigational new drug、investigational agent、IND
関: 治験

「investigational agent」

　　[★]

治験薬

関: IND、investigational drug、investigational new drug

「investigational new drug」

　　[★] 治験薬　 IND

関: investigational agent、investigational drug

「investigational」

　　[★]

adj.

研究の、調査の、治験の

関: clinical research、clinical study、clinical test、clinical trial、examine、exploration、explore、inquire、inquiry、investigate、investigation、investigative、laboratory research、probing、research、scan、study、surveillance、survey、trial、work

「investigation」

　　[★]

n.

調査(of, into)、取り調べ、研究。研究論文、調査報告。
検査

「drug」

　　[★]

同: drugs

[1] "Investigational New Drug (IND) Application". FDA. Retrieved 7 March 2013.

[4_Americans_get_medical_pot_from_the_feds-2] AP (September 27, 2011). Associated Press News http://www.cbsnews.com/news/4-americans-get-medical-pot-from-the-feds/. Missing or empty |title= (help)

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investigational drug