2015年11月20日 星期五
美國AMA實驗室:化妝品功效 臨床實驗項目
(2021.07.01:現名:美商A.S.實驗室/ ADVANCED SCIENCE LABORATORIES, INC)
化妝品功效性臨床實驗項目:
皮膚皺紋評估(Wrinkle Evaluation)
皮膚保濕度測試 (Moisturization — Hydration)
水份經皮流失測試 (Transepidermal Moisture Loss — TEML)
皮膚導電 保濕測試(Skin Moisturization by Electroconduc- tivity)
皮膚彈性測試(Skin Elasticity)
抗皮脂 腺分泌有效性測試(Anti Sebum efficacy)
皮膚油脂 分析(Sebometry Skin Lipids
皮膚表面細緻分析 (Skin Friction)
功效性臨床實驗為客製化實驗,必須就實驗設計跟客戶。
有關實驗設計詳細資料及實驗範本請來電洽詢或email本公司。
--------------------------------------------------------------------------------------------------------------------------總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
email: info@fenixbiotech.com
美國AMA實驗室:化妝品UVA/UVB (PA) 臨床實驗
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| (美國 FDA 認證皮膚臨床實驗室) |
(2021.07.01:現名:美商A.S.實驗室/ ADVANCED SCIENCE LABORATORIES, INC)
化妝品UVA/UVB (PA) 臨床實驗:
實驗依據:JCIA Method (PA, PFA, PPD) or ISO 24442
實驗項目: PA+, PA++, PA+++ , PA++++
受測人數: 依據各國法規相關規定。
美國AMA實驗室臨床實驗報告為世界各國政府機構所認可,
本實驗報告可做為化妝品UVA/UVB (PA) 防曬係數查驗登記之用。
實驗相關資料歡迎來電或email洽詢。
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總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
email: info@fenixbiotech.com
美國AMA實驗室:日用品洗劑低敏臨床實驗及化妝品安全敏感刺激臨床實驗(RIPT)
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(美國 FDA 認證皮膚臨床實驗室) |
(2021.07.01:現名:美商A.S.實驗室/ ADVANCED SCIENCE LABORATORIES, INC)
日用品洗劑低敏50人臨床實驗(RIPT):
化妝品安全敏感刺激臨50人床實驗(RIPT):
受測人數: 50 人
實驗天數: 28 天
受測人種: 不限定
受測人性別: 不限定
實驗排程:定期實驗
實驗地點:美國
*實驗報告可以請美國皮膚科醫生或小兒科醫生簽名(費用另計)
*日用品洗劑例如洗衣精、洗衣皂、洗髮乳、身體乳、洗髮乳等清潔用品低敏臨床實驗。
*實驗方法、實驗時期及報告樣本歡迎來電或email洽詢。
化妝品安全敏感刺激臨50人床實驗(RIPT):
受測人數: 50 人
實驗天數: 28 天
受測人種: 不限定
受測人性別: 不限定
實驗排程:定期實驗
實驗地點:美國
*實驗報告可以請美國皮膚科醫生或小兒科醫生簽名(費用另計)
*日用品洗劑例如洗衣精、洗衣皂、洗髮乳、身體乳、洗髮乳等清潔用品低敏臨床實驗。
*實驗方法、實驗時期及報告樣本歡迎來電或email洽詢。
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總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
email: info@fenixbiotech.com
美國AMA實驗室化妝品臨床實驗服務項目
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| (美國 FDA 認證皮膚臨床實驗室) |
(2021.07.01:現名:美商A.S.實驗室/ ADVANCED SCIENCE LABORATORIES, INC)
詳細測試項目:
Patch Tests Safety
050. 24 hour patch
051. 48 hour patch
052. Prophetic patch
48 hr Patch w/challenge
3 week test
053. Repeat Insult (RIPT)
(irritation/sensitization)
6 week test
054. Cumulative Irritation
21 day (up to 10 products)
Single Product
Dermatologist Tested Claims are available on request; additional charge Pediatrician Tested Studies are available on request; addi- tional charge Ophthalmologist Tested Studies - please see section
095.
Photobiology (Panel Study)
055. SPF Sun Protection Factor - Static (SPF 0-15/ SPF15+ - 30/ SPF 30+) FDA (US), Global Harmonization Method [COLIPA (European), JCIA(Japanese), CTFA-SA(South African) and AS/NZS (Australian/NEW Zealand)] methods are available.
060. SPF Water Resistant (WR) 40 minute immersion, or Very Water Resistant(VWR) 80 minute immersion. Both tests include Static Determination. (SPF 0-15/ SPF15+ - 30/ SPF 30+) 061. SPF Static and Water Resistance Australian/New Zealand Method (AS/NZ) - 10 subjects. 062. Combination Package: (1) FDA (US) - 20 subjects/ (2) Global Harmonization Method:[COLIPA (Europe), lCIA (Japan) and CTFA-SA (South Africa)]- 10 subjects./ (3) Option - Static Australian/New Zealand method can be added., At the conclusion of combination testing, AMA will provide individual reports for . each of the jurisdictions. Specifically, you will receive one FDA report, one Global Harmonization report covering COLIPA (Europe), JCIA (Japan) and CTFA-SA (South Africa). Additionally, if you selected the option, one Australian/ New Zealand report is included. Static Test Only:A. FDA and Global Harmonization Only./ B. Optional ASINZ (Australia/New Zealand)/ C. FDA (WR or VWR) Plus Static Global Harmonization Method (Australian Water Immersion Test combinations is available)
063. UV A Protection Efficacy: JCIA Method (PA, PFA, PPD)
065. Phototoxicity
070. Photoallergy Maximization
Skin Cancer Foundation
Assistance to acquire the seal of approval is available. The foun- dation has recently changed the previous test battery necessary for their review. The usual test profile for submission is: (1) 20 person SPF test static or WRJVWR, not less than SPF 15 (2) 50 person RIPT (3) 20 person photoxicity.
Antiperspirant
075. Antiperspirant Efficacy
080. Antiperspirant Screen
085. Antiperspirant Efficacy (FDA Monograph)
Double Blind Crossover 20
Other
090. Moisture Retention by Conductivity
091. Comedogenicity 092. Follicular Irritation
093. Transepidermal Moisture Loss (TEML)
094. Tensile Strength (Diastron Rheometer)
095. Ophthalmologist Tested - In Use Studies
096. Facial Sting Assay
097. Anti-Pruritic (Itch) Testing
Clinical Claim Substantiation Photography
AMA has introduced a novel Scientific Claim Substantiation method coupling dramatic photographic images with concomi- tant scoring of test sites by trained evaluators. A fully equipped, on-site professional studio dedicated to strict standardization policies is available for every study. Photographs are independently certified to be unaltered, cameras are cali- brated to exacting standards on regular basis to match proper white balance while color bar levels are maintained throughout the duration of the study. Highly advanced full. Two distinct formats are currently in the repertoire, lab scale and professional imaging. Ultraviolet (UV) illumination of specific target regions and 3D imagery add high caliber sophistication to dermatological studies. The techniques have proven history of acceptance from networks, electronic and print media as well as governmental and independent agencies. Final reports include, written, signed documentation, photographic images in print and/or digital (DVD, CD) media, and formal interpretation of results. Please contact our technical staff for assistance with your project. Lab Scale Photography (no report) Lab Scale Matched Scientific Photography Professional Photography (no report) Professional Matched Scientific Photography)
Exclusive Panels In-use Testing
Skin Care Treatment Studies Dry Skin, Elasticity, Tensile Strength Anti-Peeling Studies Wrinkle Reduction Anti-aging Studies Anti-oxidization Studies Anti-free radicals Studies Evaluation of Tanning Efficacy SkinLightening/Whitening Studies Melanin Studies Tyrosinase control Studies In-Vivo Lip Moisturization Soap Chamber Test. Hair Care Treatment Studies/Half Head Tests Thinning Hair Studies: Hair Shaft Diameters Anagen/Telogen Ratios Hair Counting Analysis Gravimetric Hair Pull Analysis Shampoo and Conditioner Efficacy Antidandruff Studies. Nail Product Evaluations Baby Product Evaluations Bioavailability/Bioequivalence Dental Health Products Tooth Whitener Studies Plaque/Gingivitis Anti Caries Mouthwash Irritation Toothbrush Contamination American Dental Association Seal of Acceptance assistance is available. Arthritis Studies Osteoarthritis Rheumatoid Arthritis Arthritis Foundation Ease of Use Commendation Logo assis- tance is available. Foot Care Treatment Product Panels American Podiatric Medical Association Seal of Acceptance or Seal of Approval assistance is available. Marketing Studies Focus Group Studies Panel Studies Specific protocols designed to demonstrate individual product efficacy. Volume and combination discounts are available. Please call for quotation
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總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
email: info@fenixbiotech.com
美國AMA實驗室化妝品安全性及功效性臨床實驗
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| (美國 FDA 認證皮膚臨床實驗室) |
(2021.07.01:現名:美商A.S.實驗室/ ADVANCED SCIENCE LABORATORIES, INC)
美商 AMA 實驗室成立於 1984 年,為美國食品藥物管理局(FDA)認證之專業皮膚臨床測試實驗 室(FDA 証號 2434339)。AMA 有完善的實驗設備為客戶提供科學測試、產品開發及消費行為研究 之服務。其客戶來自於化粧品、藥妝、製藥、健康食品、家用化學、食品營養、美容保健、汽 車及寵物等產業之國際知名品牌製造廠、原料供應商、配方設計研發員、生醫研究員、生技顧 問公司及獨立研發團隊等。
服務項目:
防曬係數測試(SPF): 靜態防曬係數測試(Static Test)/ 防水性測試(Water Resistant WR)/ 非常防水性測試(Very Water Resis- tant — VWR) 安全性測試(Safety Test) 重複敏感性及刺激性貼布測試(Repeat Insult Patch Test)/ 粉刺測試(Human Comedogenicity)/ 光敏感性 及光毒性測試(Phototoxity Test)/ 光最大量測試 (Photomaximization Test) 皮膚有效性研究 — 生理檢驗(Skin Studies — Bio Physical Measurements) 皮膚皺紋評估(Wrinkle Evaluation)/ 皮膚保濕度測試 (Moisturization — Hydration)/ 水份經皮流失測試 (Transepidermal Moisture Loss — TEML)/ 皮膚導電 保濕測試(Skin Moisturization by Electroconduc- tivity) / 皮膚彈性測試(Skin Elasticity)/ 抗皮脂 腺分泌有效性測試(Anti Sebum efficacy)/ 皮膚油脂 分析(Sebometry Skin Lipids/ 皮膚表面細緻分析 (Skin Friction) 。
美容沙龍(Beauty Salon) 頭髮測試(Hair) 毛髮生長分析(Trichological Count)/ 毛髮脫落分析 (Gravimetric“ pull"Analysis)/ 毛髮週期分析 “Hair Pluck"Technique/ 毛髮脫落分類研究 (Regimented Combing)/ 毛髮強度分析(Tensile Comb- ing) 指甲(Nails):包括指甲及指甲美容產品的測試。 化粧品(Cosmetics):針對化妝品提供整套分析例如色產 品彩分析(Color Analysis)及觸感分析(Sensory and Tactile Analysis)。 止汗測試(Antiperspirant Study) 消費行為研究(Consumer Research) 產品有效性的指證及證據展現(Claim Substantiation and Demonstration Development) 技術 + 商業智慧(Technology + Business Intelli- gence) 數據的管理(Data Management)/ 保密 (Confidentiality)/ 協助客戶製作產品有效性驗證圖 片(Photography)/ 完善最新可靠的儀器 (Instrumentation)/ 依醫學標準定期召募臨床測試人 員(Panelist Recruitment) 。
測試產品項目: 化粧品、藥妝、製藥、中草藥、健康食品、家用化學、食品營養、美容保健、化學原料、汽車及寵物 等使用在皮膚上或與皮膚相關產品之安全性及有效性臨床實驗。
● AMA is a registered facility with the FDA, EPA, USDA.
● Professional Society Membership: SCC, AAD, CTFA, and DCES.
AMA LABORATORIES, INC.
216 CONGERS ROAD, BLDG 5, NEW CITY,
NEW YORK 10956 U.S.A.
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總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
Email: info@fenixbiotech.com
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