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EMA versus US-FDA regulatory requirements regarding ...
System)-based biowaiver (a surrogate for in vivo bioequivalence), very rapid dissolution is defined as 85% of the labeled content is dissolved within 15 minutes, and rapid dissolution would reach the same amount within a maximum time of 30 minutes [7]. But also, formulations containing a drug substance with e.g., a long
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Basic Requirements For Aseptic Manufacturing Of Sterile ...
www.dgra.de2 1.1.2 Aseptic manufacturing Sterility is best achieved through sterile filtration of the bulk using a membrane filter (0.2 µm or less) in sterile container closure systems and working in a clean area.
Forced degradation studies – comparison between ICH, EMA ...
www.dgra.deRequirements for Registration of Pharmaceuticals for Human Use) [6] has achieved harmonization in many areas of quality e.g. in conducting of stability studies or in providing definition of relevant thresholds for impurity testing.
Regulatory requirements of Medical Devices in MENA countries
www.dgra.deGMDN Global Medical Devices Nomenclature GPCHE General People's Committee for Health and Environment HIV Human Immunodeficiency Virus i. e. Id est (Latin); English: that means IEC International Electronical commission IFU Instruction for use IMDR Interim Medical Devices Regulations IMDRF International Medical Devices Regulators Forum
Labelling Requirements for Investigational Medicinal ...
www.dgra.deLabelling is an important and integral part of the approval of a medicinal product. This also applies to the investigational medicinal product (IMP) in clinical trials (CTs). The IMP should be correctly labelled according to the mandatory information required by regulatory authorities. The label has to be permanently affixed to the container.
National dossier requirements in the European countries ...
www.dgra.deregistered. The additional requirements regarding renewal and variations will be also listed and accordingly commented based on the gathered information and in light of a harmonized single market. 3. Mutual Recognition Procedure versus Decentralised Procedure . European Union was founded between 1952 (the . European Coal and Steel Community) and
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PROPOSAL TO WAIVE IN VIVO BIOEQUIVALENCE …
www.who.intWorking document QAS/04.109/Rev.1 page 4 local usage of the API, as to whether generic formulations should be subjected to in vivo bioequivalence (BE) studies or whether a …
ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.orgconduct, and evaluation of bioequivalence studies. The possibility of using in vitro instead of in vivo studies is also addressed. 1.2 Generic medicinal products In applications for generic medicinal products , the concept of bioequivalence is fundamental. The purpose of establishing bioequivalence is to demonstrate
Guideline o the Investigation of Bioequivalence
www.ema.europa.euof bioequivalence studies. The possibility of using in vitro instead of in vivo studies is also addressed. 1.2 Generic medicinal products In applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1), the concept of bioequivalence is fundamental. The purpose of establishing bioequivalence is to
Annex 7 - WHO
www.who.int5.1 In vivo studies 142 5.2 In vitro studies 142 6. In vivo equivalence studies in humans 142 6.1 General considerations 142 6.1.1 Provisions for studies in humans 142 6.1.2 Justification of human bioequivalence studies 143 6.1.3 Selection of investigators 143 6.1.4 Study protocol 143 7. Pharmacokinetic comparative bioavailability (bioequivalence)
What Are Bioavailability and Bioequivalence
www.cadth.caBioequivalence studies are usually crossover studies in which each subject acts as their own control. This model (in vivo healthy volunteers) is regarded as adequate for detecting formulation differences. The results obtained allow extrapolation to populations in which the reference product is approved (e.g., the elderly, children, patients with
Paracetamol oral use, immediate release formulations ...
www.ema.europa.euParacetamol oral use, immediate release formulations product -specific bioequivalence guidance EMA/CHMP/356877/2017 Page 3/3 pharmacokinetics, in principle any stre ngth may be used.