「配合禁忌」

日本全国のイートモユーザーのみなさん、こんにちは。

Medical Translator NARITAです。

イートモ対訳の見直しをしているといろいろと気付きがあります。

「配合禁忌」。

ライフサイエンス辞書で調べると、以下のように出てきます。

単語ベースの情報が出ているだけ良しとするか。

医療従事者や研究者にはこの程度の情報で十分なんでしょう。

でも、医薬系翻訳者にとってはもの足りない。

センテンスベースの情報、しかも対訳がほしいのです。

究極の辞書でもいまいち。

イートモはどうかというと、、、

                       

英文	和文
Drug A is incompatible with heparin, gallium nitrate, and   total parenteral nutrition.	薬剤Aは、ヘパリン、硝酸ガリウム、完全非経口栄養《高カロリー輸液》と配合禁忌である
In vitro studies demonstrated an incompatibility between Compound A and solutions that contain cationic   components.	in vitro試験により、化合物Aと陽イオン性成分を含む溶液の配合禁忌が示された
Aminophylline is incompatible via Y-site with amiodarone, corticotropin, and diltiazem.	アミノフィリンはY字管を介してアミオダロン、コルチコトロピン、ジルチアゼムと配合禁忌である
There are no incompatibilities with Drug A.	薬剤Aとの配合禁忌はない
With chemical incompatibility, mixing two drugs alters the   integrity and potency of active ingredients.	化学的配合禁忌では、2つの薬剤を混合することにより、有効成分の完全性及び効力が変化する

センテンスベースの対訳データベースとして最小限の役割を果たしているというところでしょうか。

将来的にもっと充実させるつもりです。

"phase of development"

日本全国のイートモユーザーのみなさん、こんにちは。

　

ご無沙汰しています。

Medical Translator NARITAです。

年度末になって医学翻訳の仕事は忙しいでしょうか？

ばりばり稼ぐのはいいですが、がんばりすぎて体調を崩さないようにしてください。

体やメンタルを削ってまでやる仕事じゃないです。

8割の出来まで仕上げればいいんじゃね？

倍の時間と労力をかけて9割の出来に上げてもその差がわかる人はいないよ。多分。

さて、

"phase of development"

治験総括報告書の文脈では「開発のフェーズ」とすることになっているんですな。

http://www.pmda.go.jp/files/000156219.pdf

http://www.pmda.go.jp/files/000156923.pdf

「開発フェーズ」ではないんですね。

でも、PMDAのサイトによると、

"開発のフェーズ"の検索結果 約1,854 件

"開発フェーズ"の検索結果 約207 件

"開発の相"の検索結果 約611 件

"開発相"の検索結果 約977 件

「開発フェーズ」のケースもかなりあります。

結構ファジーなんですよ。

「開発の相」とか「開発相」がヒットするのは、「開発の相談」、「開発相談」が該当するからです。

いずれにしても、そんなに神経質になる必要はないのではないかと。

イートモ対訳

               

英文	和文
Clinical studies have been conventionally   classified by phase of development (I to IV).	臨床試験は従来から開発のフェーズ（Ⅰ～Ⅳ）別に分類されてきた
The open circles show the types   of study that may be conducted in that phase of development.	白丸はその開発のフェーズで行われる可能性がある試験のタイプを示している
The shaded circles show the   types of study most usually conducted in a certain phase of development.	黒丸はある特定の開発のフェーズで最も一般的に行われる試験のタイプを示している

"melanoma"

日本全国の医学翻訳フリーランサーのみなさん、こんにちは。

Medical Translator NARITAです。

日曜日も医学翻訳の仕事、お疲れさまです。

イートモ対訳の見直しをしているといろいろ気付くことがあります。

今回は"melanoma"。

ライフサイエンス辞書にはメラノーマ,    黒色腫と出ています。

イートモでも「メラノーマ《黒色腫》」と記載すればいいのですが、やや見づらくややなります。

そこで、いつものように、PMDAサイトで調べてみました。

黒色腫のヒットのほうがメラノーマよりも圧倒的に多い。ヒット数が多ければいいというわけではありませんが、指標にはなります。

また、"melanoma"と言えばニボルマブ。商品名オプジーボ。

添付文書を見ると、「悪性黒色腫」が使われています。

https://www.opdivo.jp/drug_info_files/drug_info/opdivo/pi/10010017/OPD_PI.pdf

さらに、ライフサイエンス辞書では、

"malignant melanoma"が 悪性黒色腫 ,    悪性メラノーマ 。

以上を総合的に考慮して、イートモでは、

"melanoma"に対応する訳語として「黒色腫」、英文に"malignant melanoma"と出ている場合には、「悪性黒色腫」、と記載します。

イートモはあくまでも参考資料です。

不良対訳もまだ多いです。

危険！　初心者はご注意ください。

実際の仕事では、いつも言っているように、クライアントからの指示や用語集に従ってください。

なお、必要に応じて、イートモの対訳は速攻で変更します。フットワークの軽いのがイートモの良いところ。

"melanoma"を含むイートモ対訳のうち英文の部分を以下に示します。ご参考まで。

例によって、機械翻訳にかけてみるかもしれません。

                                                                                                   

英文

A series of in vitro studies were conducted   with Drug A in combination with Drug B to determine the effect on cell growth   inhibition in a variety of melanoma cell   lines.

Nodular melanoma   (NM)   Superficial spreading melanoma (SSM)   Lentigo maligna melanoma (LMM)   Acral-lentiginous melanoma (ALM)

Additionally, Drug A is being studied in   combination with dacarbazine, interleukin-2, and melanoma   peptide vaccines in patients with metastatic melanoma   and with taxotere or GM-CSF in patients with hormone-refractory metastatic   prostate cancer.

Adjuvant B-Raf protein (BRAF) and/or immune   checkpoint inhibition may positively affect the survival of melanoma patients diagnosed at earlier stages.

Approximately half of the tumors were from   patients who had died of metastatic malignant melanoma.

As of January 1, 2017, ongoing clinical   studies include 5 studies in melanoma,   3 studies in colorectal cancer, and 1 study in non-small cell lung   cancer.

Basal cell carcinoma accounts for approximately   80% of non-melanoma skin cancers.

BRAFV600E melanoma cell lines that have acquired resistance to BRAF   inhibitors were more sensitive to the combination of Drug A and Drug B than   to Drug B alone.

Company A is committed to improving outcomes   for advanced melanoma patients.

Data on the incidence of non-melanoma skin cancer (NMSC) in the U.S. general   population are scarce as incidence rates of NMSC are not maintained in   national cancer registries.

Drug A did not significantly extend   disease-free survival (DFS) in patients with postsurgical melanoma when compared with a placebo in a phase   III study.

Drug A is indicated for the treatment of   adult patients with unresectable or metastatic melanoma   with a BRAF V600 mutation.

Drug A monotherapy has not been compared   with a BRAF inhibitor in a clinical study in patients with BRAF V600   mutation-positive unresectable or metastatic melanoma.

Drug A should only be used to treat malignant melanoma   with a mutation in the BRAF gene.

Drug A was approved to treat patients with melanoma that has spread to other parts of the   body or cannot be removed by surgery, whose tumors express a gene mutation   called BRAF V600E.

Drug A was first approved in the United   States on January 1, 2014, and has since been approved in Japan, for the   treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Fifteen patients with primary malignant melanoma of the vulva and two with   primary malignant melanoma of the vagina   were reviewed.

Finally, Drug A inhibited tumor   vascularization in a mouse model of melanoma.

Here, we show that polo-like kinase 1 is   overexpressed in both clinical tissue specimens and cultured human melanoma cells when compared with normal skin   tissues and cultured normal melanocytes, respectively.

In addition, objective responses were   observed in melanoma and in gastric, colorectal,   and small-cell lung cancers.

In advanced melanoma,   a patient's LDH level is often predictive of prognosis and may be a predictor   of treatment response.

In contrast, the combination of Drug A and   Drug B had little additional effect on two BRAF mutant melanoma cell lines.

In Part B, patients with BRAF-mutation   positive melanoma who had not received   prior treatment with a BRAF small-molecule inhibitor were enrolled in 4   groups in a 3 + 3 design in order to determine the recommended Part C dose of   Drug A administered concomitantly with Drug B.

In this study, escalating doses of Drug A   are being administered to patients with metastatic melanoma.

Marketing Authorization Applications were   submitted for Drug A and Drug B combination therapy in patients with BRAF   V600 mutation-positive unresectable or metastatic melanoma.

Melanoma is a cancerous lesion of skin that accounts   for nearly 75% of all skin cancer-related deaths.

Melanoma is the most aggressive and dangerous form   of skin cancer.

Metastatic melanoma   is the most serious and life-threatening type of skin cancer and is   associated with low survival rates.

Nonclinical findings using Drug A and Drug B   in combination suggest benefits of combination treatment in mitigating BRAF   inhibitor-induced effects in patients with metastatic melanoma.

Nonclinical pharmacology studies conducted   in vitro have shown that the combination of Drug A and Drug B is synergistic   in BRAF mutant melanoma cell lines that   are sensitive to both single agents.

Non-melanoma   skin cancers constitute more than one third of all cancers in the United   States.

patients with BRAF V600 mutation-positive   advanced melanoma

Patients with histologically-confirmed   cutaneous melanoma that was either   unresectable or metastatic are screened for eligibility.

Patients with stage III melanoma are generally treated by surgery to   remove the skin lesions and the nearby lymph nodes.

patients with surgically unresectable malignant melanoma

Sections from the uveal melanomas were stained using the silver nitrate   stain.

Subject A reported a Grade 3 melanoma on the forehead on Study Day 100.

Surgical excision of the lesion was   performed; histopathology confirmed a diagnosis of primary melanoma.

Ten BRAF mutant melanoma   cell lines were characterized for sensitivity to the combination of Drug A   and Drug B.

The combination therapy was first approved   in the United States on January 1, 2014 and has since been approved in   Australia, for the treatment of patients with metastatic melanoma with a BRAF V600 mutation.

The FDA approved Drug A to be used in   combination with Drug B to treat advanced melanoma   that has spread to other parts of the body or cannot be removed by surgery.

The in vivo effects of Drug A in combination   with Drug B were investigated in a xenograft model of human melanoma in mice.

The majority of patients studied to date   have had metastatic melanoma.

The safety and efficacy of Drug A have not   been evaluated in patients whose melanoma   tested negative for the BRAF V600 mutation.

There are about 200,000 new cases of melanoma diagnosed worldwide each year,   approximately half of which have BRAF mutations, a key target in the   treatment of metastatic melanoma.

This is a melanocyte-specific gene that has   been identified as a prognostic biomarker of clinical outcome in patients   suffering from melanoma, a cancerous   lesion of skin that accounts for nearly 75% of all skin cancer related   deaths.

This supplemental new drug application   provides updated information about the risk of melanoma   for patients receiving PUVA therapy.

We administered Drug A intravenously at a   dose of 10 mg per kilogram of body weight every 2 or 3 weeks in patients with   advanced melanoma, both those who had   received prior treatment with the immune checkpoint inhibitor Drug B and   those who had not.

While the introduction of BRAF inhibitors   represents a significant advance in the treatment of BRAF V600   mutation-positive metastatic melanoma   patients, limitations of this novel therapy have already been identified.

「～のうちどちらか～のほう」

大阪の医学翻訳フリーランサーのみなさん、こんにちは。

Medical Translator NARITAです。

午後のひと時、いかがおすごしでしょうか。

「～のうちどちらか～のほう」関連のイートモ対訳を調べておきました。

例によってニューラルMTにかけてみるかもしれないので、そのときにイートモの和訳を紹介するかもです。

                                   

英文

A   dose not exceeding 1/100 of the dose expressing pharmacological effects or a   dose of 100 µg/human, whichever is smaller, is administered once to healthy subjects.

Any subject noted to experience virologic breakthrough that occurs after   Week 12 are required to have HCV RNA testing within 2 weeks of receipt of the   initial HCV RNA measurement or at the next scheduled visit, whichever is sooner.

It is necessary to place the label   about 6-8 cm away from the camera or in contact with the front of the camera, whichever works better.

Patients were monitored every 4 weeks until these levels were achieved,   or for 2 years, whichever was the shorter.

Progression-free survival (PFS) was   calculated from the date of random assignment to the date of first   progression or death, whichever occurred first.

Sexually transmitted disease medical records other than positive   syphilis tests must be kept 7 years past the last date of service or until   the patient's 21st birthday, whichever comes   later.

The director of the study site shall retain the essential documents to be   archived at the study site until the day specified in 1) or 2) below, whichever is later.

The head of the medical institution   will retain the essential documents to be retained at the medical institution   until the date given in 1) or 2) below, whichever   is later.

The head of the study site must retain study drug disposition records,   copies of CRFs, and source documents for the maximum period required by   applicable regulations and guidelines or for the period specified by the   sponsor, whichever is longer.

The   institutional review board (IRB) organizer will retain the IRB procedure   manual, IRB member list, review documents, notifications from the head of the   institution, records on the IRB meetings, and other similar documents until   the date given in 1) or 2) below, whichever is later.

The investigator must retain all study records and source documents for the   maximum period required by applicable regulations and guidelines or for the   period specified by the sponsor, whichever is   longer.

The investigator must retain study   drug disposition records for the maximum period specified by guidelines or   for the period specified by the sponsor,   whichever is longer.

The organizer of the institutional review   board (IRB) shall retain the written procedures of operating the IRB, the   list of IRB members, review documents, notifications from the director of the   study site, records of IRB meetings, etc. until the day specified in 1) or 2)   below, whichever is later.

This is a period from the date of   patent registration or the first date of the clinical study, whichever is later, to the date   of approval.

Total participation in the study for each subject will be   approximately ten weeks with long-term follow-up lasting until the next   episode of exacerbation or for up to 12 months,   whichever occurs first.

You may be granted a visa valid for   up to 5 years or until your passport expires,   whichever comes first.

さて、柿の木坂オフィスのパソコンで使っているマウスが壊れました。渋谷デスクに来ているので、ついでにマウスを買います。

マウスが壊れるくらいだから、肘にもガタがきますよね。

「同意書」

神戸にお住まいの医学翻訳フリーランサーのみなさん、こんにちは。

Medical Translator NARITAです。

さて、イートモ対訳の見直しをしていると、いろいろ気付くことがあります。

今回は「同意書」をどう英訳するか。

イートモで検索すればすぐわかりますが、イートモにも不良対訳が多いので、念のため調べてみることにします。

思い浮かぶのは、

consent form

informed consent form

の2つ。

CROとか製薬会社とか、それぞれのホームページに用語集のようなものを出しているようです。

それらを参考にするのもいいですが、クライアントからの指定がなければ、役所のサイトを基準にするのがいいと思います。

「治験関係の用語はPMDAサイトに準拠しました」とコメントを記載すればばっちりです。

PMDA先生で調べてみます。

"consent form"の検索結果　約130 件

"informed consent form"の検索結果　約114 件

つまり、consent formのほとんどのケースにinformedがセットになっていると推察されます。

件数が多ければいいというわけではないけど、1つの指標にはなります。

個々の文書を実際に見てみると、実際にセットになっています。

よって、治験への参加同意の文脈では、イートモでも基本的に"informed consent form"を使うことにします。

"consent form"でイートモを検索した結果です。

84件がヒットしました。

今回は和文を提示していません。

                                                                                               

英文

A copy of any changes or renewals   of the informed consent form also must be sent promptly to the study monitor.

a copy of the IRB-approved informed   consent form and other adjunctive materials

A   parent or guardian of a minor patient must also read and initial each item   before signing the informed consent form.

A sample case report form (CRF) is provided in Appendix 1, while   Appendix 2 contains a sample informed consent   form.

Additional reference is made to the   above IND777, and to the model Informed Consent   Form for Study A sent to the regulatory authority   for review on May 1, 2017.

After having been informed that participation is voluntary and that   the participants may withdraw from the study at any time, without prejudice,   the patient must sign the IRB- and sponsor-approved informed consent form in the   presence of a witness.

After the informed consent form is read to   the subject and signed by the subject, the witness should also sign the consent form, attesting the subject   freely gave that informed consent.

After the patient has signed the informed   consent form to participate in the study, a   registration sheet will be completed and faxed or emailed to the sponsor for   approval of entry of the patient onto the study.

All concomitant therapies must be recorded throughout the study beginning with   signing of the informed consent form until the end-of-study visit.

Anticipated benefits of the study drug and anticipated disadvantage to the   subjects must be described in the informed   consent form and explained to the subjects prior   to enrollment in this study.

Any changes to the informed consent form suggested by   the investigator must be approved by the sponsor before submission to the   IRB, and a copy of the approved version must be provided to the sponsor's   monitor.

Any changes to the informed consent   form suggested by the investigator must be   approved by the sponsor before submission to the IRB/IEC.

Any updates to the informed consent form will be   provided to the subject.

Appendix 1 contains a copy of a sample informed consent form.

Before implementing this study, the   protocol, the informed consent form, and other information to subjects must be reviewed by a   properly constituted institutional review board.

Before study initiation, the Investigator must have approval from the   IRB/IEC for the protocol, informed consent form, subject recruitment materials, and any other written   information to be provided to subjects.

By signing this consent form, you agree to follow   your doctor's instructions, attend all study-related visits, and perform all   study specific assessments.

By signing this consent form, you give the Sponsor permission to use material obtained from   your blood sample for the research described above.

Company A has made the change to   the informed consent form for Study A, taking into account the available data.

During a subject's participation in the study, any updates to the informed consent form and any   updates to the written information will be provided to the subject.

Each subject   must sign the informed consent form after the nature of the study has been fully explained.

Entries in the Case Report Forms are verified   using subject files, informed consent forms signed by subjects, drug accountability forms, and original   recordings from automated instruments, X-ray films, laboratory notes, etc.

explanatory   materials and consent form used   for obtaining informed consent

For the conduct of the phase III clinical studies, specific   language will be included in the informed consent   form to address the potential for impairment of   fertility.

I will receive a signed copy of   this informed consent form.

If an amendment substantially alters the study design or   increases the potential risk to the subject, the informed   consent form must be revised and submitted to the   IRB/IEC via the head of the study site for review and approval/favorable   opinion.

If the original signed informed consent form will be   filed with the subject's source documents, a memo, describing that the   original informed consent form has been filed with the subject's source documents, should be   displayed in the Regulatory Binder.

If the subject had no prior medical history or current conditions   at the time of signing informed consent form, select “No” and leave the rest of the CRF blank.

If the subject is unable to read   the informed consent form, an impartial witness should be present during the entire   informed consent discussion.

If written informed consent was obtained, enter the date informed consent form was signed by   the guardian or subject.

If you decide that you do not want   to participate in this research, you may still participate in the clinical   study and receive the study drug if you have signed the informed consent form for the   clinical study and continue to qualify for the clinical study.

If you decide to participate, you will be   asked to sign this informed consent form.

In   a correspondence dated May 1, 2017, Company A accepted the regulatory   authority's recommendation and committed to submitting an updated version of   the model informed consent form   when it became available.

Informed consent form will be sent to the subject beforehand, but will not be filled   in until the screening visit.

Once you know about the study and   the tests that will be done, you will be asked to sign this consent form to join this study.

Patients who meet all of the inclusion criteria and none of the exclusion   criteria described below and who agree to voluntarily sign the informed consent form will be   considered “enrolled” into the study.

Preparation of the informed consent form must adhere   to GCP and to the ethical principles that have their origin in the   Declaration of Helsinki.

Prior to performance of any study-related activity, the informed consent form should be   signed and dated by the subject or his/her legally acceptable representative   and by the person who conducted the informed consent discussion.

Proposed   text for inclusion in the informed consent form is as follows: …

Samples collected for exploratory pharmacogenetic analysis will be   retained for up to 15 years, as indicated in the informed   consent form.

Signing   this consent form does not   take away all of your legal rights. You still have rights as a participant in   a study.

Subjects and legally acceptable   representatives must sign an informed consent form after the nature of the study has been fully explained and all   questions have been answered to the subject's satisfaction.

The "Track Changes"   mechanism in Microsoft Word should be used when making changes to the informed consent form.

The contract research organization (CRO) must   approve all informed consent forms used in the study prior to submission to the IRB.

The   date the first subject signs a study-specific informed   consent form will be defined as the start of the   study.

The document should include the date the subject signed the informed consent form and that a   signed copy was given to the subject.

The   impartial witness should sign and date the informed   consent form attesting that the information is   accurate.

The informed consent form and any other written information provided to the subject should   be revised whenever important new information becomes available that is   relevant to the subject’s consent.

The informed consent form must include a statement that the sponsor and regulatory   authorities have direct access to subject records.

The informed consent form must be dated   and signed prior to any screening procedures.

The informed consent form must have been approved by the sponsor and the investigator's   institutional review board.

The informed consent form should also   provide an explanation of the potential risk associated with QT interval   prolongation in language that can be understood by the patients.

The informed consent form should be updated or amended whenever new information becomes   available that may be relevant to the subject.

The informed consent form should   include all requirements according to local law.

The   institutional review board or ethics committee must review this protocol and   the informed consent form prior   to initiating this study.

The investigator making the explanation must date and sign or seal the informed consent form to make the   consent effective.

The investigator must keep a copy   of the signed informed consent form.

The investigator must obtain the Institutional Review Board's written approval   of the informed consent form and any other written information to be provided to the   subjects via the head of the study site, prior to the beginning of the study.

The investigator must provide the   subject or legally acceptable representative with a copy of the informed consent form and written   information about the study.

The investigator must provide the subject or legally acceptable representative   with the informed consent form and written information about the study in language that is   non-technical and easily understood.

The investigator must provide the   subject with a copy of the informed consent form and written information about the study in language that is   non-technical and easily understood.

The investigator must revise the informed consent   form whenever important new information becomes   available that is relevant to the subject's consent.

The investigator should allow time   necessary for the subject to inquire about the details of the study, then the   informed consent form   must be signed and dated by the subject and the person who conducted the   informed consent discussion.

The medical expert will assist in creating and reviewing all study-related   documents, including the sample informed consent   form and the investigator's brochure.

The protocol and the informed consent form were reviewed   and approved by the investigator's IRB before initiation of the study.

The protocol and the informed consent form will receive Institutional Review Board (IRB)/Independent   Ethics Committee (IEC) approval/favorable opinion prior to initiation of the   study.

The   purpose of this informed consent form is to give you information so that you can decide whether you   want to provide an additional blood sample(s) in conjunction with the   clinical study of Drug A in which you may participate.

The required topics to be included in the informed consent form are listed in   Appendix 1.

The   revised informed consent form   must be used to obtain consent from subjects currently enrolled in the study.

The sample informed consent form will adhere to the ethical principles that have their origin   in the Declaration of Helsinki.

The sponsor must have a copy of   written and dated approval from the Institutional Review Board for the   protocol, informed consent form, subject recruitment materials (e.g., advertisements), and any   other written information to be provided to subjects.

The sponsor will provide the investigator with an appropriate sample informed consent form which will   include all elements required by ICH, GCP, and regulatory requirements.

The study drug will not be   distributed to an investigator until the institutional review board (IRB) or   ethics committee has provided written approval of the study and informed consent form to the   investigator.

The subject agrees, when signing the informed   consent form, that they will not be provided with   the results from the research, nor will the results be available at any time.

The   subject must sign an informed consent form documenting this discussion.

The subjects will be asked to read and understand an informed consent form designed   specifically for the purpose of collecting a blood sample for genetic   research.

This   consent form tells you about   the study that you may wish to join.

This consent form may contain words that you do not understand.

This   informed consent form should   only be modified to the extent necessary to meet applicable legal   requirements.

This page is   used to collect all prior psoriasis therapies up to the point when the   subject signed the informed consent form.

Upon signing the informed consent form, the patient   is assigned the sequential number by the Investigator.

When the patient has signed the informed   consent form, the investigator or his/her staff   will telephone the Committee and provide the identifying information for the   patient.

You will be asked to sign a   separate consent form   for the extension study.

You will be asked to sign an informed consent form at screening.

ではでは。

post-marketingか、postmarketingか

医学翻訳フリーランサーのみなさん、こんにちは。

Medical Translator NARITAです。

どっちでもいいんでしょうが、

イートモ対訳の見直しをしていると、

post-marketingとpostmarketingのどちらかに統一したほうがいいのかどうか、

と考えることがあります。

そこで、PMDAサイトとFDAサイトで調べてみました。

結果は両方ともほぼ半々。

やはりどっちでもいいということでしょうか。

当面、イートモではどちらかに統一することはせず、

今後の状況を見ながら、必要に応じて修正していくことにします。

フットワークが軽いことがイートモのいいところ。

せっかくなので、イートモ対訳を紹介しておきます。

イートモの収録用ファイルの画面です。

【post-marketingを含む対訳】

　

【postmarketingを含む対訳】

　

なお、post-marketing clinical studyは「製造販売後臨床試験」としました。これについても今後の情勢変化に応じて、必要ならば速攻で修正していきます。

ではでは。

Standard Operating Procedure

寒い中、医学翻訳の仕事や勉強、お疲れさまです。

Medical Translator NARITAです。

イートモ対訳の見直しをしていると、いろいろ気付くことがあります。

皆さんご存知、Standard Operating Procedure。

SOP。

英訳では問題ないのですが、和訳の場合とか、イートモ対訳を作成する場合には対応する日本語をどうするか。

標準業務手順書

標準作業手順書

標準操作手順書

三通り出てきます。

迷ったときはPMDAサイトか、Google先生で調べます。

標準業務手順書と標準作業手順書が多い様子。

標準操作手順書もあるけど、実験とか機械操作の文脈で使われることが多いようです。　

治験関係では、

標準業務手順書

標準作業手順書

が多い様子。

とりあえず、イートモでは、

標準業務手順書《標準作業手順書》

と掲載しておきます。

必要に応じて修正、変更します。フットワークが軽いのがイートモのいいところ。

念のためですが、いつも書いているように、迷ったときはクライアントの指示や資料に従ってください。あるいは、翻訳会社に判断させてください。イートモはあくまでも参考資料です。

Standard Operating Procedureで検索したときのイートモデータベースの画面です（イートモで検索した結果ではありません）。ご参考まで。

英文だけというけち臭いことをしないで、英文と和文の両方を提示しています。w

The usualで始まる英文

すべてに当てはまるわけではないでしょうが、医薬系の文書の場合、"The usual"で始まる英文センテンスは「通常、～」と和訳すると自然な和文（医薬分野で情報交換に使われるタイプの和文）になることが多いようです。

以下にイートモ対訳を1つだけ提示します。コピペできます。

   

The usual adult dose for oral use is   10 mg as Compound A immediately before bedtime.

通常、成人には化合物Aとして10mgを就寝直前に経口投与する

他の"The usual"で始まるイートモ対訳の英文です。

和文は提示しません。

いずれも、「通常、～」の形式で処理できます。

                 

The usual adult dose for oral use is 10 mg of Drug A daily in two to   three divided doses after meals.

The usual adult dose is 50 mg of   Drug A per oral twice a day in the morning and evening.

The usual dose for prevention of upper gastrointestinal bleeding in   critically ill patients is 40 mg daily for 14 days.

The usual dose of 10 mg is   administered once daily for up to 4 weeks.

The usual dose of cyclosporine is 4 to 5 mg/kg per day, given in two   equally divided doses.

The usual form of corticosteroid   therapy is prednisone, beginning with 20 mg/day and increasing the dose   gradually until a satisfactory clinical response is obtained, or until a   daily dose of 50-60 mg is reached.

The usual initial dosage of Drug A is 100 mg daily, given in two divided   doses.

The usual practice has been to   initiate an alternate-day schedule, which diminishes the side effects.

The usual recommended oral dose of Drug A in adults and adolescents   older than 16 years is 1.0 mg once daily.

英文と和文の両方を知っていないと、和文を見て瞬間的に英文が思い浮かびません。

英訳と和訳の両方できることが理想なのでしょう。

コピペ

医学翻訳の学習中のみなさん、こんにちは。

Medical Translator NARITAです。

メカ音痴のMedical Translator NARITAにはココログへのイートモサンプルの貼り付け方がよくわからなくて、和文の右側が切れている状態になっています。

http://i-honyaku.cocolog-nifty.com/blog/2019/01/washout.html

とか

http://i-honyaku.cocolog-nifty.com/blog/2019/01/colonizationcol.html

とか。

ワードに変換してPDFにして、リンクすればいいんですが、ちょっと面倒くさくて。。。

今気づいたのですが、コピーして、ワードとかメモ帳などにペーストできるようです。英文と和文のすべてをコピペできます。

医学翻訳の勉強に利用してください。

ちょっと思ったのですが、宣伝用とは言え、これだけ有用な情報を無料で提供するのはどうかなと。。。

http://i-honyaku.cocolog-nifty.com/blog/2018/12/post-3ac8.html

http://i-honyaku.cocolog-nifty.com/blog/2018/03/post-bd22.html

つまり、高額ではないけど、イートモに価値を見出してくださって、注文して、購入してくださっている方のことを思うと、貴重な情報を無料で提供するわけにはいかないのではないかと思ったのです。

http://i-honyaku.cocolog-nifty.com/blog/2018/01/post-b61d.html

イートモの宣伝と情報提供の中間を狙っていこうかなと。

ま、医学翻訳ブログをフォローしてくださっている方はお気づきだと思いますが、Medical Translator NARITAなんて者は気分屋で、いーかげん。思いつきで動くやつですので、医学翻訳ブログのコンテンツはころころ変わることをご了承ください。

なお、1月31日に次期バージョン（イートモ6.2）を発売する予定です。

イートモ6.1の対訳データは古くなるので、イートモ6.1のイートモサンプルは削除しました。

http://i-honyaku.cocolog-nifty.com/blog/cat24141906/index.html

今後はイートモ6.2に基づきイートモサンプルを紹介してまいります。

washout

医学翻訳フリーランサーのみなさん、午後もお仕事、お疲れさまです。

Medical Translator NARITAは15時頃までイートモ作業して、その後は心療内科に行ってきます。

ところで、みなさんご存知washout。

最近では「休薬」で訳が決まりつつあるようです。

clinicalではそれで大丈夫ですが、nonclinicalのin vitro関係になると単純ではないよね。

例えば、

Washout of the drug was done by superfusion of the cells with a drug-free solution using a peristaltic pump.

単純じゃないでしょ。これも対訳化してイートモに収録します。

ライフサイエンス辞書

washout

(薬物などの)   洗い流し,    洗い出し

元々はそういう意味だったのでしょうが、治験関係で使われるようになって、「休薬」という訳が当てられるようになったのかもしれません。

ま、我々は学者じゃないので、訳の由来なんてどうでもいいのですが、「本剤の洗い流し」ではいまいち。

Google先生で調べても、持田製薬さんの文書に、

また、皮膚障害を発現した症例の中で、. 本剤の洗い流しが不十分であった症例もあり、本剤を使用される際は「必ず」洗い流していただくよう、文言. の追記を致しました。

という記載がありますが、これは文字通り「洗い流すこと」。

和訳の場合、カタカナ表記でしのいで、とにかく納品しようかと考えるわけです。

一応Google先生で確認すると、

これらのデータは、本剤のウォッシュアウトに必要な十分な時間を設けてミガーラスタットによるα-Gal A 活性阻害を最小限にすれば、ファブリー病患者の線維芽細胞において、ミガーラスタットによるα-Gal A 活性増加はGL-3濃度を低下させることを示している。

とか

かん流液を用いた対照実験後、ミガーラスタット塩酸塩を低濃度から順にそれぞれ5 個の細胞に曝露後、ウォッシュアウトした。

とか

現場の文書に使われています。リンクが切れているようです。

http://app.cocolog-nifty.com/t/app/weblog/post?blog_id=722376

代わりにPMDAのサイトのもの。

http://www.pmda.go.jp/drugs/2015/P20150601007/100888000_22700AMX00649_A100_1.pdf#page=7

今はこのような文書がネットからいくらでも入手できるからすごい。

Medical Translator NARITAが医学翻訳ブログで何度も書いているように、こういう現場の文書をライフサイエンス辞書やGoogle、イートモ、英じ郎で調べながら、訳文を完成させるトレーニングを続けるしかないんです。

今の時代、自分で現場の仕事と同じ経験ができるんだから、翻訳スクールに行って講師の話を受け身的に聞いてもしょうがないと思うけどなー。

みなさん翻訳スクールに行けば「魔法の法則」を教えてくれると思っているようで。

http://i-honyaku.cocolog-nifty.com/blog/2018/10/post-cae9.html

さて、せっかくなので、イートモでもwashoutを調べてみました。

例によって、和文の右側が切れています。

青字がnonclinicalのin vitro関係ということなりまかね。やはり、イートモには治験関係が多いので、今後はnonclinical関係も意識して増やしていこうと思います。

　 

A   3-month washout period was required before baseline evaluation of women using   postmenopausal hormones at initial screening.

A 4-week washout period from HMG-CoA   reductase inhibitors and cholesterol absorption inhibitors is required.

A single oral dose of one 20-mg   tablet was to be administered after breakfast followed by ≥ 7 days of the   washout period.

After a 1-week washout period, the procedures were repeated with the   alternate rinse.

After a 2-week washout period,   subjects were crossed over to receive the other medication for 8 days.

All subjects who were on combination therapy at entry must undergo a 28-day   washout period of DMARDs other than Drug A.

Changes   seen in the liver and stomach were still present at the end of the 1-month   washout period, although with a lower incidence and severity, indicating an   ongoing recovery process.

Drug A caused total suppression of HIV production in ABC cells for 20 days   after washout of the drug and replacement with fresh culture medium.

Drug A was administered as either a   single dose or as two divided doses given 12 hours apart, with a 7-day   washout period between treatments.

Washout of the drug was done by superfusion   of the cells with a drug-free solution using a peristaltic pump.

Due to the short half-life of Drug   A, a washout of 1 day was considered adequate.

Each cycle consisted of 3 daily intravenous administrations   followed by a 4-day washout period.

Each patient   received inhaled Drug A or placebo twice daily for a month, with a one-week   washout period between treatments.

Eligible patients using antihypertensive treatments will, under the supervision   of the investigator, stop their antihypertensive treatments and enter a   washout phase of 2 weeks.

Eligible patients were enrolled   into a 2-week washout period, during which the number of incontinence   episodes and frequency of micturition were recorded for 7 consecutive days   using micturition diaries.

Exercise tolerance tests were performed at baseline; 20 to 24 hours   after dosing at Weeks 4, 8, and 12; and at the end of the washout period.

From Day 16 to Day 28, no   medication was administered (washout period).

Healthy subjects were studied at baseline, after cocoa supplementation   for 6 weeks, and after a 6-week washout period.

Mean serum phosphorus rose from 6.8   mg/dl at prewashout to 9.1 mg/dl at the end of the washout period.

No washout period separated Treatment B and Treatment C.

Rabbit   aortic strips were exposed to various sympathomimetic amines; after washout   of the amines the relaxation of the strips was measured.

Ten healthy subjects were randomized to receive single doses of Drug A 20 mg SC or   10 mg IV infusion with a 4-week washout period between doses.

The duration of plasma sample   collection and the washout time between treatments were not long enough to   appropriately characterize the AUC, ke, and t1/2 of Drug A.

The duration of this washout period was not sufficient to characterize the   rate of loss of the treatment effect.

The effect was largely reversible   after washout of Drug A.

The first treatment period, the washout period, and the second treatment   period were each eight weeks long.

The   one-week washout period between Treatment A (Drug A alone) and Treatment B   (Drug B alone) was used in order to determine steady-state pharmacokinetic   parameters for Drug A without the influence of Drug B.

The patients were given a second opportunity to rate their current status on   the same questionnaire on which they had previously marked their end of   washout scores.

The study was divided into a   20-week double-blind active treatment phase followed by a 10-week washout   period.

The vehicle group and the 30 mg/kg group included their recovery subgroup   in which reversibility of the toxicity was investigated during 13-week   washout period.

The   washout period for any previous medical therapy for Disease A was adequate.

There was no evidence of rebound worsening of lung function in the Drug A   group after the washout period.

Thereafter, patients underwent a   one-week NSAID-free washout period.

These values returned to baseline levels over a 4-week washout period after   cessation of Drug A administration.

Treatment periods were separated by   a washout period of ≥ 7 days.

Treatment was followed by a two-week, single-blind washout period during   which all patients received placebo.