41.下列何者不是為小兒族群用藥而撰寫之參考資料？
(A)Harriet Lane Handbook
(B)Neofax
(C)Pediatric Dosage Handbook
(D)Purple Book

Harrison’s principles of internal medicine: 

為內科學入門教科書

Harriet Lane Handbook: A Manual for Pediatric House Officers:

每年一版的兒童用藥小冊子，經 Johns Hopkins Hospital 小兒科醫生編輯，參考價值高

Purple Book：收錄美國生物製劑藥品包含生物相似性藥品跟interchangeable biological products

Orange Book：收錄美國學名藥

The Purple book is a list of biological products, including biosimilars and interchangeable biological products, approved or licensed by Food and Drugs Administration (FDA) under the Public Health Service Act (the PHS Act). 

The orange book is a list of generic drugs approved by FDA.

感謝4F糾正 已修改

Ref: https://www.freyrsolutions.com/what-are-purple-and-orange-books

https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or

3F有寫錯喔，Purple book是收集由Center for Drug Evaluation and Research (CDER)管理的生物製劑藥品喔。如:cellular and gene therapy, hematologic, and vaccine products

網址：https://purplebooksearch.fda.gov/about

1. 標準藥物 (Reference Product)

The single biological product, already approved by FDA, against which a proposed biosimilar product is compared.

1.  生物相似性藥品“Biosimilar” or “Biosimilarity”

The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product.

我的理解: 和標準藥物相似(沒有太多差異)的藥品

1.  可替代生物製劑“Interchangeable” biological product

A product that has been shown to be biosimilar to the reference product, and can be expected to produce the same clinical result as the reference product in any given patient.

An interchangeable biological product must be shown that for a biological product that is administered more than once to an individual the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

我的理解: 要求比較嚴格，除了biosimilar之外，還需有結果證實這些藥品和標準藥物能產生相同的臨床結果。(可互相替代) 

Ref: 高醫 生物製劑講義ww   

理解有錯誤歡迎更正

Red book-阿共的社交平台 感染科相關(感染發炎會紅

Orange book-美國食品藥物管理局FDA官方出版的書冊，正式名稱為「具治療等效性評估之核准藥品目錄(橘子沒放均勻，爬月台會掉滿地

Yellow book-國際旅遊健康相關(非洲拉丁美洲小心黃熱病

Green book-疫苗相關(打了疫苗綠燈可通行

Blue book-醫療花費相關(被討錢就臉色鐵青

Purple book-生物製劑相關(紫色的史萊姆

White book-住院醫師/相關醫療人員參考書(大多穿白袍