investigational new drug

治験薬　IND

関

investigational agent、investigational drug

WordNet

1. unfamiliar; "new experiences"; "experiences new to him"; "errors of someone new to the job"
2. having no previous example or precedent or parallel; "a time of unexampled prosperity" (同)unexampled
3. (of crops) harvested at an early stage of development; before complete maturity; "new potatoes"; "young corn" (同)young
4. not of long duration; having just (or relatively recently) come into being or been made or acquired or discovered; "a new law"; "new cars"; "a new comet"; "a new friend"; "a new year"; "the New World"
5. other than the former one(s); different; "they now have a new leaders"; "my new car is four years old but has only 15,000 miles on it"; "ready to take a new direction"
6. unaffected by use or exposure; "it looks like new"
7. information about recent and important events; "they awaited news of the outcome" (同)intelligence, tidings, word
8. informal information of any kind that is not previously known to someone; "it was news to me"
9. information reported in a newspaper or news magazine; "the news of my death was greatly exaggerated"
10. use recreational drugs (同)do drugs
11. administer a drug to; "They drugged the kidnapped tourist" (同)dose
12. a substance that is used as a medicine or narcotic
13. the work of inquiring into something thoroughly and systematically (同)investigating

PrepTutorEJDIC

1. (その状態になってまだ時間がたっていなくて)『新しい』;《名詞の前にのみ用いて》新しく発見(発明)された,新しく来た / 《名詞の前にのみ用いて》目新しい,初めて聞く,なじみのない / 《補語にのみ用いて》(人が)(…に)『まだ慣れていない』,(…を)よく知らない《『to』+『名』》 / 《補語にのみ用いて》(人が)(…から)出てきたばかりの《+『from』+『名』》 / 《名詞の前にのみ用いて》まだ着た(使った)ことがない,新品の / 新たに始まる;(肉体的・精神的に)一新した / 《おもに複合語を作って》最近(recently);新たに,新しく(newly)
2. (新しい)『報道』,記事;(一般的に)知らせ,たより) / (耳新しい)『事件』,でき事 / 《N-》(新聞名として)…新聞
3. 『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
4. (…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）』「2015/09/18 13:02:26」(JST)

wiki en

[Wiki en表示]

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice Drug Enforcement Administration
Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

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.

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.

See also

• Abigail Alliance for Better Access to Developmental Drugs
• Drug Discovery
• Expanded access ("compassionate use")
• FDA Fast Track Development Program
• Inverse benefit law
• New drug application
• Executive Order 13139

References

• 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.

Further reading

• Henninger, Daniel (2002). "Drug Lag". In David R. Henderson (ed.). Concise Encyclopedia of Economics (1st ed.). Library of Economics and Liberty.  OCLC 317650570, 50016270 and 163149563

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. 薬物療法の最新情報 whats new in drug therapy
• 4. HIV薬剤耐性検査アッセイの概要 overview of hiv drug resistance testing assays
• 5. 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

English Journal

• European regulations for the introduction of novel radiopharmaceuticals in the clinical setting.

• Decristoforo C1, Penuelas I2, Patt M3, Todde S4.
• The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of...Q J Nucl Med Mol Imaging.2017 Jun;61(2):135-144. doi: 10.23736/S1824-4785.17.02965-X. Epub 2017 Jan 26.
• PMID 28124548

• The future of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection.

• Özdener AE1, Park TE2,3, Kalabalik J1, Gupta R4.
• Expert review of anti-infective therapy.Expert Rev Anti Infect Ther.2017 May;15(5):467-481. doi: 10.1080/14787210.2017.1309292. Epub 2017 Apr 4.
• PMID 28322067

• Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

• Kamenov Z1, Fileva S2, Kalinov K3, Jannini EA4.
• Maturitas.Maturitas.2017 May;99:20-26. doi: 10.1016/j.maturitas.2017.01.011. Epub 2017 Feb 12.
• PMID 28364864

Japanese Journal

• 『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
• … 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 …
• NAID 130003362539

• 大学附属病院臨床試験施設における早期探索的臨床試験の実施の課題とこれから

• 梅村 和夫
• 臨床薬理 = Japanese journal of clinical pharmacology 43(3), 189-190, 2012-05-31
• NAID 10030763663

• 早期探索的臨床試験と「承認」に向けた開発戦略 : 趣旨説明と今後の展望

• 栗原 千絵子
• 臨床薬理 = Japanese journal of clinical pharmacology 43(3), 187-188, 2012-05-31
• NAID 10030763657

Related Pictures

---

★リンクテーブル★

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

「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 drug」

　　[★]

• 治験薬

関

IND、investigational agent、investigational new drug

「investigational agent」

　　[★]

• 治験薬

関

IND、investigational drug、investigational new 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

「n」

　　[★]

• n.

• 例数

関

number of experiment、sample size

• pの前の[n]はmと記載する。synptom→symptom

「news」

　　[★]

• n.

• ニュース、記事、報道、知らせ

関

article、report

　 　 　 　

「investigation」

　　[★]

• n.

• 調査(of, into)、取り調べ、研究。研究論文、調査報告。
• 検査

　 　

「new」

　　[★]

• 新しい、新

関

neo、novel