日志
Word？2007-04-23
B.E.T.——Barrett-Emmett-Telleller (一种比表面积测试方法，氮吸附静态容量法)
w.r.t.——with regard to/with respect to
LAF——Laminar Air Flow，空气层流
PDR——Physicians' Desk Reference，(美国)医生参考手册
FBD——Flow Bed Drying，流化床干燥
SG——Specific Gravity，比重
CRC——Child-resistant Cap，儿童安全盖
HDPE——高密度聚乙烯
HDPP——高密度聚丙烯
CMC——羧甲基纤维素钠
EC——乙基纤维素
MC——甲基纤维素
MCC——Micro Crystal Cellulose，微晶纤维素
HEMC——羟乙基甲基纤维素
HEC——羟乙基纤维素
HPC——羟丙基纤维素
HPMC——Hydroxypropyl methylcellulose (Hypromellose)，羟丙基甲基纤维素
ABS——丙烯腈-丁二烯-苯乙烯
PET——Polyethylene Terephthalate，聚对苯二甲酸乙二醇酯
PVC——Polyvinylchlorid，聚氯乙烯材料
PP——聚丙烯
PS——聚苯乙烯
BSE——Bovine Spongiform Encephalopathy
TSE——Transmissible Spongiform Encephalopathy
GMO——Genetically Modified Organisms
ABPI Association of the British Pharmaceutical Industry
ADR Adverse Drug Reaction
AE Adverse Event
AIM Active Ingredient Manufacturer
ANDA Abbreviated New Drug Application
ANOVA Analysis of Variance
ASM: Active Substance Manufacturer
ATC Anatomical Therapeutic Chemical
ATX Animal Test Exemption Certificate
BAN British Approved Name
BIRA British Institute of Regulatory Affairs
BNF British National Formulary
BP British Pharmacopoeia
C of A Certificate of Analysis
C of S Certificate of Suitability
CENTRE FOR DRUG EVALUATION (CDE)
Centre for Pharmaceutical Administration (CPA)
CMS Concerned Member State
CMS每个成员国
COS Certificate of Suitability
CPMP Committee for Proprietary Medicinal Products
CRA Clinical Research Associate
CRF Case Report Form
CRO Contract Research Organisation
CTA Clinical Trial Application
CTC Clinical Trial Certificate
CTD Common Technical Document
CTX Clinical Trials Exemption
DDD Defined Daily Dose
DGC Daily Global Comparison
DIA Drug Information Association
DMF Drug Master File
Drug Registration Branch (DRB), Product Evaluation & Registration Division, CPA
EDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会
EEA 欧洲经济地区
EGMA European Generics Medicine Association
ELA Established Licence Application
EMEA European Medicines Evaluation Agency
EMEA （European Agency for the Evaluation of Medicinal Products） 欧洲联盟药品评价机构
EP European Pharmacopoeia
EPAR European Public Assessment Reports
ESRA European Society of Regulatory Affairs
European Pharmacopoeia Commission 欧洲药典委员会
FDA
FDA Food and Drug Administration
final evaluation report (FER)
free sale certificates (FSCs)
GCP Good Clinical Practice
GCP药品临床研究管理规范
GLP Good Laboratory Practice
GLP 药品临床前安全性研究质量管理规范
GMP Good Manufacturing Practice
GMP 药品生产质量管理规范
GSP药品销售管理规范
Health Sciences Authority (HSA)
HSA’s Medicines Advisory Committee (MAC)
IB Investigators Brochure
ICH International Conference for Harmonisation
IDMC Independent Data-Monitoring Committee
IEC Independent Ethics Committee
IND Investigational New Drug
INN International Non-proprietary Name
International Conference on Harmonisation (ICH)
IPC In Process Control
IRB Institutional Review Board
LICENCE HOLDER
MA Marketing Authorisation
MAA Marketing Authorisation Application 上市申请
MAH Marketing Authorisation Holder 销售许可持有者
MCA Medicines Control Agency
MHW Ministry of Health and Welfare (Japan)
MR Mutual Recognition
MRA 美国与欧盟的互认协议
MRAs (Mutual Recognition Agreements) 互相認證同意
MRFG Mutual Recognition Facilitation Group
MRP Mutual Recognition Procedure
NAS New Active Substance
NCE New Chemical Entity
NDA New Drug Application
new chemical entities (NCEs)
new drug applications (NDAs)
NSAID Non Steroidal Anti Inflammatory Drug
NTA Notice To Applicants
OOS Out of Specification
OTC Over The Counter
PAGB Proprietary Association of Great Britain
Ph Eur European Pharmacopoeia
PIL Patient Information Leaflet
PL Product Licence
POM Prescription Only Medicine
PRODUCT OWNER
PSU Periodic Safety Updates
QA Quality Assurance
QC Quality Control
RAJ Regulatory Affairs Journal
RMS Reference Member State 相互认可另一成员国
RSD Relative Standard Deviation
Rx Prescription Only
SAE Serious Adverse Event
SMF Site Master File
SOP Standard Operating Procedure
SOP STANDARD OPERATION PROCEDURE 标准运作程序
SPC/SmPC Summary of Product Characteristics
SPC summary of product characteristics
TGA Therapeutic Goods Administration
USP US Pharmacopoeia
VMF Veterinary Master File
VPC Veterinary Products Committee
