 |
| (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
----------------------------------------------------------------------------------------------------------------------
總代理: 鳳麗生技有限公司
Tel: 886-02-2277-3543
email: info@fenixbiotech.com
沒有留言:
張貼留言