ベラパミル
概要
説明
ベラパミルは、フェニルアルキルアミン系カルシウムチャネルブロッカーであり、主に高血圧、狭心症、特定の種類の不整脈などの心臓血管疾患の治療に使用されます . ベラパミルは、1960年代初頭に治療法として導入された最初のカルシウムチャネル拮抗薬でした . ベラパミルは、経口剤や静脈注射剤など、さまざまな製剤で提供されており、心拍数の制御と血流の改善における有効性で広く認識されています .
製法
合成経路と反応条件
ベラパミルは、3,4-ジメトキシフェニルエチルアミンとイソバレリルクロリドを反応させて中間体を生成し、その後に特定の条件下で3,4-ジメトキシベンジルシアニドと反応させるという多段階プロセスを経て合成されます . 最終生成物は精製され、通常99％を超える高純度が得られます .
工業生産方法
ベラパミルの工業生産では、通常、ラボ設定と同様の反応経路を使用しますが、効率性とコスト効率を最適化して大規模合成が行われます。 イオン交換樹脂やリポソーム調製法などの技術が、薬物のバイオアベイラビリティと徐放性を高めるために用いられています .
作用機序
科学的研究の応用
Verapamil has a wide range of scientific research applications:
Chemistry: Used as a model compound in studies of calcium channel blockers and their interactions with other molecules.
Medicine: Extensively studied for its therapeutic effects in treating cardiovascular diseases, migraines, and cluster headaches
Industry: Utilized in the development of sustained-release formulations and other drug delivery systems.
生化学分析
Biochemical Properties
Verapamil interacts with various enzymes and proteins, primarily through its role as a calcium channel blocker. It is known to interact with cytochrome P450 enzymes, which are involved in its metabolism . Verapamil is also a potent inhibitor of P-glycoprotein function , which plays a crucial role in drug transport and distribution.
Cellular Effects
Verapamil has been shown to have significant effects on various types of cells and cellular processes. It influences cell function by blocking calcium channels, which can impact cell signaling pathways, gene expression, and cellular metabolism . For instance, verapamil has been found to regulate the thioredoxin system and promote an anti-oxidative, anti-apoptotic, and immunomodulatory gene expression profile in human islets .
Molecular Mechanism
Verapamil exerts its effects at the molecular level primarily through its role as a calcium channel blocker. It binds to L-type calcium channels, inhibiting the influx of calcium ions into cells . This can lead to a decrease in intracellular calcium levels, which can affect various cellular processes, including muscle contraction, cell signaling, and neurotransmitter release.
Temporal Effects in Laboratory Settings
In laboratory settings, the effects of verapamil can change over time. For example, a study showed that long-term low-dose verapamil effectively prevents the development of cognitive impairment induced by a certain compound in aged animals . This suggests that verapamil may have long-term effects on cellular function in both in vitro and in vivo studies.
Dosage Effects in Animal Models
The effects of verapamil can vary with different dosages in animal models. For instance, a study showed that verapamil at a dose of 1mg/kg/d prevented the development of cognitive impairment in an aged mouse model of sporadic Alzheimer’s disease .
Metabolic Pathways
Verapamil is involved in various metabolic pathways. It is subject to extensive oxidative metabolism mediated by cytochrome P450 enzymes, with less than 5% of an oral dose being excreted unchanged in urine . Verapamil is also known to be a potent inhibitor of P-glycoprotein function, which can affect the transport and distribution of various other drugs .
Transport and Distribution
Verapamil is widely distributed throughout body tissues . It is transported and distributed within cells and tissues primarily through its interaction with P-glycoprotein, a transporter protein that plays a crucial role in drug transport and distribution .
Subcellular Localization
A study investigating the transport of fluorescence-labeled verapamil at the blood-retinal barrier suggested that verapamil may be partially sequestered in lysosomes within retinal pigment epithelial cells .
準備方法
Synthetic Routes and Reaction Conditions
Verapamil is synthesized through a multi-step process that involves the reaction of 3,4-dimethoxyphenethylamine with isovaleryl chloride to form an intermediate, which is then reacted with 3,4-dimethoxybenzyl cyanide under specific conditions . The final product is purified to achieve a high degree of purity, often greater than 99% .
Industrial Production Methods
Industrial production of verapamil typically involves large-scale synthesis using similar reaction pathways as in laboratory settings but optimized for efficiency and cost-effectiveness. Techniques such as ion exchange resins and liposome preparation methods are employed to enhance the drug’s bioavailability and controlled release .
化学反応の分析
反応の種類
ベラパミルは、酸化、還元、置換など、さまざまな化学反応を起こします。 これらの反応は、ベラパミルの代謝と薬物動態に不可欠です .
一般的な試薬と条件
ベラパミルを伴う反応で使用される一般的な試薬には、オゾンやヒドロキシルラジカルなどの酸化剤が含まれます . これらの反応の条件は、特定の代謝物の生成など、望ましい結果が得られるように慎重に制御されます。
生成される主な生成物
ベラパミルの反応から生成される主な生成物には、主に腎臓から排泄される代謝物が含まれます . これらの代謝物は、薬物の薬理作用と潜在的な副作用を理解する上で重要です。
科学研究への応用
ベラパミルは、幅広い科学研究に用いられています。
類似化合物との比較
類似化合物
ベラパミルは、ジルチアゼムやフルナリジンなどの他の化合物を含む、非ジヒドロピリジン系のカルシウムチャネルブロッカーに属します . これらの化合物は、同様の作用機序を共有していますが、化学構造と薬物動態のプロファイルが異なります。
独自性
ベラパミルは、抗不整脈薬と降圧薬の両方の役割を果たす能力において独特であり、さまざまな心臓血管疾患の治療に汎用性があります . その独特の化学構造により、カルシウムチャネルとの特定の相互作用が可能になり、他のカルシウムチャネルブロッカーと比べて、より幅広い治療範囲を提供します .
特性
IUPAC Name |
2-(3,4-dimethoxyphenyl)-5-[2-(3,4-dimethoxyphenyl)ethyl-methylamino]-2-propan-2-ylpentanenitrile |
Source
|
|---|---|---|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
InChI |
InChI=1S/C27H38N2O4/c1-20(2)27(19-28,22-10-12-24(31-5)26(18-22)33-7)14-8-15-29(3)16-13-21-9-11-23(30-4)25(17-21)32-6/h9-12,17-18,20H,8,13-16H2,1-7H3 |
Source
|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
InChI Key |
SGTNSNPWRIOYBX-UHFFFAOYSA-N |
Source
|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
Canonical SMILES |
CC(C)C(CCCN(C)CCC1=CC(=C(C=C1)OC)OC)(C#N)C2=CC(=C(C=C2)OC)OC |
Source
|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
Molecular Formula |
C27H38N2O4 |
Source
|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
DSSTOX Substance ID |
DTXSID9041152 |
Source
|
| Record name | (+/-)-Verapamil | |
| Source | EPA DSSTox | |
| URL | https://comptox.epa.gov/dashboard/DTXSID9041152 | |
| Description | DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology. | |
Molecular Weight |
454.6 g/mol |
Source
|
| Source | PubChem | |
| URL | https://pubchem.ncbi.nlm.nih.gov | |
| Description | Data deposited in or computed by PubChem | |
Physical Description |
Solid |
Source
|
| Record name | Verapamil | |
| Source | Human Metabolome Database (HMDB) | |
| URL | http://www.hmdb.ca/metabolites/HMDB0001850 | |
| Description | The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body. | |
| Explanation | HMDB is offered to the public as a freely available resource. Use and re-distribution of the data, in whole or in part, for commercial purposes requires explicit permission of the authors and explicit acknowledgment of the source material (HMDB) and the original publication (see the HMDB citing page). We ask that users who download significant portions of the database cite the HMDB paper in any resulting publications. | |
Boiling Point |
BP: 245 °C at 0.01 mm Hg, 243-246 °C at 1.00E-02 mm Hg |
Source
|
| Record name | Verapamil | |
| Source | Hazardous Substances Data Bank (HSDB) | |
| URL | https://pubchem.ncbi.nlm.nih.gov/source/hsdb/3928 | |
| Description | The Hazardous Substances Data Bank (HSDB) is a toxicology database that focuses on the toxicology of potentially hazardous chemicals. It provides information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. The information in HSDB has been assessed by a Scientific Review Panel. | |
| Record name | Verapamil | |
| Source | Human Metabolome Database (HMDB) | |
| URL | http://www.hmdb.ca/metabolites/HMDB0001850 | |
| Description | The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body. | |
| Explanation | HMDB is offered to the public as a freely available resource. Use and re-distribution of the data, in whole or in part, for commercial purposes requires explicit permission of the authors and explicit acknowledgment of the source material (HMDB) and the original publication (see the HMDB citing page). We ask that users who download significant portions of the database cite the HMDB paper in any resulting publications. | |
Solubility |
Solubility (mg/mL): water 83, ethanol (200 proof) 26, propylene glycol 93, ethanol (190 proof) >100, methanol >100, 2-propanol 4.6, ethyl acetate 1.0, DMF >100, methylene chloride >100, hexane 0.001; Freely soluble in chloroform, practically insoluble in ether /Verapamil hydrochloride/, Practically insoluble in water, Sparingly soluble in hexane; soluble in benzene, ether; freely soluble in the lower alcohols, acetone, ethyl acetate, chloroform, 4.47 mg/L |
Source
|
| Record name | Verapamil | |
| Source | Hazardous Substances Data Bank (HSDB) | |
| URL | https://pubchem.ncbi.nlm.nih.gov/source/hsdb/3928 | |
| Description | The Hazardous Substances Data Bank (HSDB) is a toxicology database that focuses on the toxicology of potentially hazardous chemicals. It provides information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. The information in HSDB has been assessed by a Scientific Review Panel. | |
| Record name | Verapamil | |
| Source | Human Metabolome Database (HMDB) | |
| URL | http://www.hmdb.ca/metabolites/HMDB0001850 | |
| Description | The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body. | |
| Explanation | HMDB is offered to the public as a freely available resource. Use and re-distribution of the data, in whole or in part, for commercial purposes requires explicit permission of the authors and explicit acknowledgment of the source material (HMDB) and the original publication (see the HMDB citing page). We ask that users who download significant portions of the database cite the HMDB paper in any resulting publications. | |
Mechanism of Action |
Verapamil inhibits L-type calcium channels by binding to a specific area of their alpha-1 subunit,Cav1.2, which is highly expressed on L-type calcium channels in vascular smooth muscle and myocardial tissue where these channels are responsible for the control of peripheral vascular resistance and heart contractility. Calcium influx through these channels allows for the propagation of action potentials necessary for the contraction of muscle tissue and the heart's electrical pacemaker activity. Verapamil binds to these channels in a voltage- and frequency-dependent manner, meaning affinity is increased 1) as vascular smooth muscle membrane potential is reduced, and 2) with excessive depolarizing stimulus. Verapamil's mechanism of action in the treatment of angina and hypertension is likely due to the mechanism described above. Inhibition of calcium influx prevents the contraction of vascular smooth muscle, causing relaxation/dilation of blood vessels throughout the peripheral circulation - this lowers systemic vascular resistance (i.e. afterload) and thus blood pressure. This reduction in vascular resistance also reduces the force against which the heart must push, decreasing myocardial energy consumption and oxygen requirements and thus alleviating angina. Electrical activity through the AV node is responsible for determining heart rate, and this activity is dependent upon calcium influx through L-type calcium channels. By inhibiting these channels and decreasing the influx of calcium, verapamil prolongs the refractory period of the AV node and slows conduction, thereby slowing and controlling the heart rate in patients with arrhythmia. Verapamil's mechanism of action in the treatment of cluster headaches is unclear, but is thought to result from an effect on other calcium channels (e.g. N-, P-, Q-, or T-type). Verapamil is known to interact with other targets, including other calcium channels, potassium channels, and adrenergic receptors., Calcium antagonists inhibit excitation-contraction coupling in myocardial and smooth muscle by blocking the transmembrane carrier of calcium. This results in decreased myocardial contractility and in vasodilatation. ... /Salt not specified/, Verapamil has been shown to be neuroprotective in several acute neurotoxicity models due to blockade of calcium entry into neurons. However, the potential use of verapamil to treat chronic neurodegenerative diseases has not been reported. Using rat primary mesencephalic neuron/glia cultures, we report that verapamil significantly inhibited LPS-induced dopaminergic neurotoxicity in both pre- and post-treatment experiments. Reconstituted culture studies revealed that the presence of microglia was essential in verapamil-elicited neuroprotection. Mechanistic studies showed that decreased production of inflammatory mediators from LPS-stimulated microglia underlay neuroprotective property of verapamil. Further studies demonstrated that microglial NADPH oxidase (PHOX), the key superoxide-producing enzyme, but not calcium channel in neurons, is the site of action for the neuroprotective effect of verapamil. This conclusion was supported by the following two observations: 1) Verapamil failed to show protective effect on LPS-induced dopaminergic neurotoxicity in PHOX-deficient (deficient in the catalytic subunit of gp91(phox)) neuron/glia cultures; 2) Ligand binding studies showed that the binding of (3)H-verapamil onto gp91(phox) transfected COS7 cell membranes was higher than the non-transfected control. The calcium channel-independent neuroprotective property of verapamil was further supported by the finding that R(+)-verapamil, a less active form in blocking calcium channel, showed the same potency in neuroprotection, inhibition of pro-inflammatory factors production and binding capacity to gp91(phox) membranes as R(-)-verapamil, the active isomer of calcium channel blocker. In conclusion, our results demonstrate a new indication of verapamil-mediated neuroprotection through a calcium channel-independent pathway and provide a valuable avenue for the development of therapy for inflammation-related neurodegenerative diseases. |
Source
|
| Record name | Verapamil | |
| Source | DrugBank | |
| URL | https://www.drugbank.ca/drugs/DB00661 | |
| Description | The DrugBank database is a unique bioinformatics and cheminformatics resource that combines detailed drug (i.e. chemical, pharmacological and pharmaceutical) data with comprehensive drug target (i.e. sequence, structure, and pathway) information. | |
| Explanation | Creative Common's Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/legalcode) | |
| Record name | Verapamil | |
| Source | Hazardous Substances Data Bank (HSDB) | |
| URL | https://pubchem.ncbi.nlm.nih.gov/source/hsdb/3928 | |
| Description | The Hazardous Substances Data Bank (HSDB) is a toxicology database that focuses on the toxicology of potentially hazardous chemicals. It provides information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. The information in HSDB has been assessed by a Scientific Review Panel. | |
Color/Form |
Viscous, pale yellow oil | |
CAS No. |
52-53-9 |
Source
|
| Record name | Verapamil | |
| Source | CAS Common Chemistry | |
| URL | https://commonchemistry.cas.org/detail?cas_rn=52-53-9 | |
| Description | CAS Common Chemistry is an open community resource for accessing chemical information. Nearly 500,000 chemical substances from CAS REGISTRY cover areas of community interest, including common and frequently regulated chemicals, and those relevant to high school and undergraduate chemistry classes. This chemical information, curated by our expert scientists, is provided in alignment with our mission as a division of the American Chemical Society. | |
| Explanation | The data from CAS Common Chemistry is provided under a CC-BY-NC 4.0 license, unless otherwise stated. | |
| Record name | Verapamil [USAN:INN:BAN] | |
| Source | ChemIDplus | |
| URL | https://pubchem.ncbi.nlm.nih.gov/substance/?source=chemidplus&sourceid=0000052539 | |
| Description | ChemIDplus is a free, web search system that provides access to the structure and nomenclature authority files used for the identification of chemical substances cited in National Library of Medicine (NLM) databases, including the TOXNET system. | |
| Record name | Verapamil | |
| Source | DrugBank | |
| URL | https://www.drugbank.ca/drugs/DB00661 | |
| Description | The DrugBank database is a unique bioinformatics and cheminformatics resource that combines detailed drug (i.e. chemical, pharmacological and pharmaceutical) data with comprehensive drug target (i.e. sequence, structure, and pathway) information. | |
| Explanation | Creative Common's Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/legalcode) | |
| Record name | (+/-)-Verapamil | |
| Source | EPA DSSTox | |
| URL | https://comptox.epa.gov/dashboard/DTXSID9041152 | |
| Description | DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology. | |
| Record name | Verapamil | |
| Source | European Chemicals Agency (ECHA) | |
| URL | https://echa.europa.eu/substance-information/-/substanceinfo/100.000.133 | |
| Description | The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. | |
| Explanation | Use of the information, documents and data from the ECHA website is subject to the terms and conditions of this Legal Notice, and subject to other binding limitations provided for under applicable law, the information, documents and data made available on the ECHA website may be reproduced, distributed and/or used, totally or in part, for non-commercial purposes provided that ECHA is acknowledged as the source: "Source: European Chemicals Agency, http://echa.europa.eu/". Such acknowledgement must be included in each copy of the material. ECHA permits and encourages organisations and individuals to create links to the ECHA website under the following cumulative conditions: Links can only be made to webpages that provide a link to the Legal Notice page. | |
| Record name | VERAPAMIL | |
| Source | FDA Global Substance Registration System (GSRS) | |
| URL | https://gsrs.ncats.nih.gov/ginas/app/beta/substances/CJ0O37KU29 | |
| Description | The FDA Global Substance Registration System (GSRS) enables the efficient and accurate exchange of information on what substances are in regulated products. Instead of relying on names, which vary across regulatory domains, countries, and regions, the GSRS knowledge base makes it possible for substances to be defined by standardized, scientific descriptions. | |
| Explanation | Unless otherwise noted, the contents of the FDA website (www.fda.gov), both text and graphics, are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required. | |
| Record name | Verapamil | |
| Source | Hazardous Substances Data Bank (HSDB) | |
| URL | https://pubchem.ncbi.nlm.nih.gov/source/hsdb/3928 | |
| Description | The Hazardous Substances Data Bank (HSDB) is a toxicology database that focuses on the toxicology of potentially hazardous chemicals. It provides information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, nanomaterials, and related areas. The information in HSDB has been assessed by a Scientific Review Panel. | |
| Record name | Verapamil | |
| Source | Human Metabolome Database (HMDB) | |
| URL | http://www.hmdb.ca/metabolites/HMDB0001850 | |
| Description | The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body. | |
| Explanation | HMDB is offered to the public as a freely available resource. Use and re-distribution of the data, in whole or in part, for commercial purposes requires explicit permission of the authors and explicit acknowledgment of the source material (HMDB) and the original publication (see the HMDB citing page). We ask that users who download significant portions of the database cite the HMDB paper in any resulting publications. | |
Melting Point |
< 25 °C |
Source
|
| Record name | Verapamil | |
| Source | Human Metabolome Database (HMDB) | |
| URL | http://www.hmdb.ca/metabolites/HMDB0001850 | |
| Description | The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body. | |
| Explanation | HMDB is offered to the public as a freely available resource. Use and re-distribution of the data, in whole or in part, for commercial purposes requires explicit permission of the authors and explicit acknowledgment of the source material (HMDB) and the original publication (see the HMDB citing page). We ask that users who download significant portions of the database cite the HMDB paper in any resulting publications. | |
Synthesis routes and methods I
Procedure details
Synthesis routes and methods II
Procedure details
Synthesis routes and methods III
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Retrosynthesis Analysis
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| Template Set | Pistachio/Bkms_metabolic/Pistachio_ringbreaker/Reaxys/Reaxys_biocatalysis |
| Top-N result to add to graph | 6 |
Feasible Synthetic Routes
Q1: What is Verapamil's primary molecular target?
A1: Verapamil primarily targets L-type voltage-gated calcium channels (Cav1.2) [, , , ]. These channels play a crucial role in calcium influx, influencing various physiological processes, particularly in cardiac and smooth muscle cells.
Q2: How does Verapamil interact with L-type calcium channels?
A2: Verapamil exhibits a higher affinity for the inactivated state of L-type calcium channels []. Binding to these channels, Verapamil inhibits calcium influx, leading to a decrease in intracellular calcium concentration.
Q3: What are the downstream effects of Verapamil's interaction with its target?
A3: By inhibiting calcium influx through L-type channels, Verapamil exerts several downstream effects, including:
- Cardiac: Decreased heart rate, reduced myocardial contractility, and prolonged atrioventricular (AV) nodal conduction time [, , , ].
- Vascular: Relaxation of vascular smooth muscle, leading to vasodilation and reduced blood pressure [, , ].
Q4: What is the molecular formula and weight of Verapamil?
A4: Verapamil's molecular formula is C27H38N2O4, and its molecular weight is 454.6 g/mol.
Q5: What is the bioavailability of orally administered Verapamil?
A5: Oral Verapamil has a low and variable bioavailability, averaging around 22% due to significant first-pass metabolism [].
Q6: How does Verapamil's metabolism impact its pharmacokinetic profile?
A6: Verapamil undergoes extensive hepatic metabolism, primarily by cytochrome P450 enzymes, particularly CYP3A4 [, ]. This leads to the formation of several metabolites, including norVerapamil, which also possesses pharmacological activity [, ].
Q7: Does Verapamil interact with other drugs?
A7: Yes, Verapamil can interact with various drugs due to its effects on drug-metabolizing enzymes and P-glycoprotein. For example, it can increase digoxin concentrations [], potentially leading to toxicity.
Q8: What are the main clinical applications of Verapamil?
A8: Verapamil is clinically used for treating various cardiovascular conditions, including:
- Supraventricular tachycardia (SVT): Intravenous Verapamil effectively terminates AV nodal reentrant tachycardia [].
- Hypertension: Verapamil lowers blood pressure [, ] and was found to be as effective as hydrochlorothiazide in achieving target blood pressure but with fewer patients requiring combination therapy [].
- Angina pectoris: Verapamil improves exercise capacity and reduces angina symptoms [, , ].
- Hypertrophic cardiomyopathy: Verapamil improves hemodynamic parameters and exercise capacity in patients with this condition [, ].
Q9: Are there differences in Verapamil's efficacy in different patient populations?
A9: Research suggests potential differences in Verapamil's effectiveness among different patient groups:
- Age: In elderly patients with ischemic heart disease, Verapamil was less effective than Diltiazem in increasing exercise duration, although it improved ischemic thresholds [].
- Training Status: Studies on sweating responses showed that L-type calcium channel blockade with Verapamil had a more pronounced effect on cholinergic sweating in trained individuals compared to untrained individuals [].
試験管内研究製品の免責事項と情報
BenchChemで提示されるすべての記事および製品情報は、情報提供を目的としています。BenchChemで購入可能な製品は、生体外研究のために特別に設計されています。生体外研究は、ラテン語の "in glass" に由来し、生物体の外で行われる実験を指します。これらの製品は医薬品または薬として分類されておらず、FDAから任何の医療状態、病気、または疾患の予防、治療、または治癒のために承認されていません。これらの製品を人間または動物に体内に導入する形態は、法律により厳格に禁止されています。これらのガイドラインに従うことは、研究と実験において法的および倫理的な基準の遵守を確実にするために重要です。
