cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；cro企業(yè),cro公司,cro,北京cro,北京cro公司,北京cro企業(yè)；

對(duì)于準(zhǔn)備進(jìn)入兒童用藥市場(chǎng)的企業(yè)來(lái)說(shuō)，政策釋放的信號(hào)是產(chǎn)業(yè)界是否“投入”的晴雨表。

    國(guó)家食品藥品監(jiān)督管理總局（CFDA）藥品審評(píng)中心在網(wǎng)站發(fā)布了《兒科人群藥代動(dòng)力學(xué)技術(shù)指導(dǎo)原則》（征求意見(jiàn)稿）（下稱《指導(dǎo)原則》），意見(jiàn)征集工作將于本月28日結(jié)束。

    科學(xué)合理設(shè)定注冊(cè)政策

    原藥品審評(píng)中心主任張象麟認(rèn)為，兒童藥研發(fā)技術(shù)上的特點(diǎn)和困難給注冊(cè)政策提出了兩個(gè)方面的考量：其一，已上市藥品如何“轉(zhuǎn)化”為兒童用藥，包括大量臨床數(shù)據(jù)的利用和判讀，也涉及對(duì)改劑型、變規(guī)格、改包裝的處置；其二，兒童藥臨床試驗(yàn)指導(dǎo)原則和審評(píng)要求科學(xué)合理的設(shè)定，在眾多的期待下，獲益和風(fēng)險(xiǎn)的權(quán)衡策略也是個(gè)不小的挑戰(zhàn)。

    隨著業(yè)界對(duì)兒童用藥的關(guān)注度持續(xù)升高，我國(guó)兒童用藥所面臨的問(wèn)題令利益相關(guān)者開始思考如何從實(shí)踐層面推動(dòng)兒童藥的研發(fā)、注冊(cè)和市場(chǎng)的良性發(fā)展。

    《指導(dǎo)原則》系統(tǒng)地對(duì)兒科人群藥代動(dòng)力學(xué)特點(diǎn)進(jìn)行闡述，并以設(shè)計(jì)和方法學(xué)為重點(diǎn)，就如何安全、有效并符合醫(yī)學(xué)倫理地在兒科人群中進(jìn)行藥代動(dòng)力學(xué)的關(guān)鍵技術(shù)要點(diǎn)進(jìn)行分析和說(shuō)明，重點(diǎn)闡明了兒科人群的特殊關(guān)注之處。

    藥品審評(píng)中心化藥臨床一部楊煥指出，新藥在開展兒科臨床之前一般考慮5點(diǎn)：第一，了解兒科人群發(fā)育特點(diǎn)及與成人生理差異；第二，學(xué)習(xí)成人的臨床數(shù)據(jù)；第三，通過(guò)成人的藥代特征分析兒童可能的藥代變化；第四，分析幼年動(dòng)物數(shù)據(jù)；第五，確定最為合適的劑型。

    中國(guó)醫(yī)師協(xié)會(huì)兒科醫(yī)師分會(huì)會(huì)長(zhǎng)朱宗涵認(rèn)為，如果《指導(dǎo)原則》能夠順利出臺(tái)，將有助于全面認(rèn)識(shí)兒科人群與藥物間的相互作用，為臨床制定合理用藥方案提供依據(jù)。

   兒童試驗(yàn)倫理學(xué)挑戰(zhàn)

    截至2013年9月，CFDA共發(fā)布36份公告，其中446家公示的醫(yī)療機(jī)構(gòu)中含兒科專業(yè)的臨床機(jī)構(gòu)共51家（兒童?？漆t(yī)院及婦幼醫(yī)院共計(jì)9家），兒科專業(yè)共134個(gè)。

    首都醫(yī)科大學(xué)附屬北京兒童醫(yī)院副院長(zhǎng)申昆玲坦言，雖然近年來(lái)能夠開展兒童藥臨床試驗(yàn)的醫(yī)療機(jī)構(gòu)越來(lái)越多，但大部分機(jī)構(gòu)專業(yè)數(shù)量較少，且沒(méi)有統(tǒng)一的操作規(guī)范，很難滿足多中心兒童藥臨床試驗(yàn)的基本要求，更遠(yuǎn)遠(yuǎn)不能滿足約占患病總?cè)丝?0%的患病兒童用藥需求。

    早前CFDA副局長(zhǎng)尹力在接受《人民日?qǐng)?bào)》專訪時(shí)特別談到我國(guó)兒童藥研發(fā)和用藥所面臨的問(wèn)題，認(rèn)為兒童的生理狀況決定了臨床試驗(yàn)面臨更多的倫理障礙，這些問(wèn)題需要在政策上加以引導(dǎo)和鼓勵(lì)。

    “我國(guó)現(xiàn)行GCP要求，兒童作為藥物的受試者，必須征得其法定監(jiān)護(hù)人的知情同意并簽署知情同意書，當(dāng)兒童能做出決定時(shí)，還必須征得其本人的同意?！鄙昀チ嶂赋?，現(xiàn)階段臨床試驗(yàn)對(duì)兒童的倫理學(xué)要求越來(lái)越高，試驗(yàn)規(guī)范性要求趨嚴(yán)。

    但實(shí)踐證明，8歲以下兒童認(rèn)知能力較差，家長(zhǎng)引導(dǎo)因素多，基本不能作為本人意愿；8歲以上兒童稍有認(rèn)知能力，但意向多變，即便當(dāng)時(shí)同意，也不能算作長(zhǎng)期穩(wěn)定意愿，目前來(lái)看只有12歲以上的兒童能夠較完整的理解參與一項(xiàng)藥物臨床的意涵。

-- New test will help increase access for earlyinfant HIV diagnosis

PLEASANTON, California, Feb. 18, 2014 /PRNewswire/-- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its dual-targetHIV-1 qualitative test, v2.0[1] has received CE Mark certifications, allowingit to be sold for clinical use in the European Union and those countriesaccepting CE Marked products.  The test simultaneously amplifies anddetects two separate regions of the HIV-1 genome, which are not subject toselective drug pressure.  This unique, dual target design allows for morereliable results to confidently and effectively diagnose HIV-1 infection.

The new dual-target HIV-1 qualitative test, v2.0works with both plasma and dried blood spot (DBS) collection cards tofacilitate PCR testing, and more importantly make sample collection andtransportation easy, even from the smallest infant in the most rural area.

The DBS collection card and the need for moresensitive and accurate information to diagnose babies early in their life andpatients across many African countries is instrumental to facilitate the stateof the art healthcare required for the region.  The HIV-1 dual targetqualitative test and DBS cards eliminates need for refrigeration, drasticallyreduces the volume of blood to be stored or transported, and the stress for themother and the child is dramatically improved.

"The ability to determine the HIV status of aninfant as early as six weeks is crucial to determining the appropriate care andsupport for HIV-positive babies," stated Paul Brown, President of RocheMolecular Diagnostics.  "With this new solution from Roche, we arereiterating our commitment to healthcare solutions that make a real differencefor patients."

About Early HIV Infant Diagnosis

Diagnosing HIV in infants and young children is amajor challenge. Antibody tests are ineffective in children because themother's antibodies remain in the child's system following birth.  Infact, antibody tests in infants may yield false positive results for up to 15months. There are a number of alternate methods available for early diagnosisof HIV infected infants. Many approaches use molecular techniques, specificallydetecting the viral DNA and/or RNA, which enables HIV diagnosis as early as sixweeks.

Early diagnosis is critical for children infectedwith HIV. If found HIV positive, they can receive appropriate medical carebefore they develop significant illness, and can remain healthy despite theirinfection. If found HIV negative, the mother can get appropriate counseling toensure their child maintains a HIV-free status.

About the test

The COBAS? AmpliPrep/COBAS? TaqMan? HIV-1Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acidamplification test for the qualitative detection of Human ImmunodeficiencyVirus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasmaor dried blood spots using the COBAS? AmpliPrep Instrument for automatedspecimen processing and the COBAS? TaqMan? Analyzer or COBAS? TaqMan? 48Analyzer for automated amplification and detection.

The test is a diagnostic test, indicated forindividuals who are suspected to be actively infected with HIV-1. Detection ofHIV-1 TNA is indicative of active HIV infection. Infants born to mothersinfected with HIV-1 may have maternal antibodies to HIV-1, and the presence ofHIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults,the test may be used as an aid in the diagnosis of HIV-1 infection.

About HIV-1

Accordingly to the World Health Organization (WHO),there were 35 million people living with HIV around the world in 2012. Thatsame year 2.5 million people became newly infected with HIV worldwide.[2] For the most impacted region of Sub-Saharan Africa nearly 1 in every 20 adultsor 69% of all people living in this region are with HIV positive.

The transmission of HIV from an HIV-positive motherto her child during pregnancy, labor, delivery or breastfeeding is called verticalor mother-to-child transmission (MTCT). In the absence of any interventions HIVtransmission rates are between 15-45%.

Diagnosis, highly active antiretroviral treatment(HAART) and viral load tests, a test to determine the amount of circulatingHIV, have contributed to a steady increase in life expectancy for HIV infectedpeople of 13 years.

兒童藥倫理“保衛(wèi)”升級(jí)

2014年10月21日發(fā)布