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Critical reviews of global practices of ctd and ectd format for drug approval process

01 Jan 2015-

TL;DR: The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities.

AbstractThe major pharmaceutical market in the world is United States. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common. Technical Document (CTD) has become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. An electronic CTD (ECTD) was developed in parallel with the CTD. Three ICH regions US, Europe and Japan now accept eCTD filings. The ECTD has advantages over the CTD in terms of ease of use, archiving and for life - cycle management of registration information. The ECTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the ECTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the needs for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities. It is organized into five modules. Module 1 is region specific, while Modules 2, 3, 4, and 5 are intended to be common for all regions. A regional component is included in Module 3.ECTD format enables pharmaceutical companies to submit applications to various regulatory authorities such as FDA without altering the data. ECTD format is now widely used in the United States, Japan, the European Union and Canada.

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References
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Journal ArticleDOI
TL;DR: In reliable animal models of depression tianeptine has been shown to prevent neurodegeneration and decreases in hippocampal volume in response to chronic stress, and provides further support for the hypothesis that depression may involve dysregulation of pathways controlling cellular resilience and that treatment should be directed towards the reversal thereof.
Abstract: Tianeptine, an atypical antidepressant patented and developed by Servier, enhances the synaptic reuptake of serotonin, without affecting norepinephrine and dopamine uptake, while it lacks affinity for neurotransmitter receptors. This mechanism for an antidepressant is apparently paradoxical, since the currently employed antidepressants enhance serotonin by inhibiting its breakdown or by inhibiting monoaminergic reuptake. Although tianeptine has been shown to reduce central 5HT availability and to indirecty modulate central adrenergic and dopaminergic systems and to indirectly inhibit cholinergic hyperactivity, its antidepressant action is believed to be more directly related to central neuronal remodeling and restoration of neuronal plasticity. In reliable animal models of depression tianeptine has been shown to prevent neurodegeneration and decreases in hippocampal volume in response to chronic stress. These effects on neuroplasticity are suspected to involve the normalization of the hypothalamic-pituitary-adrenal axis and modulatory effects on excitatory amino acids and N-methyl-D-aspartate receptors. Together with a body of related studies, these data provide further support for the hypothesis that depression may involve dysregulation of pathways controlling cellular resilience and that treatment should be directed towards the reversal thereof. Importantly, tianeptine is not anxiogenic and has also been shown to be effective in treatment-resistant depression, which may lead the way to a major breakthrough in the treatment of depression.

62 citations

Journal ArticleDOI
TL;DR: A near infrared (NIR) method was developed for determination of tablet potency of active pharmaceutical ingredient (API) in a complex coated tablet matrix and an easy to use graphical interface was developed to easily determine if the predictions are within the specifications defined by the regulatory organisation.
Abstract: A near infrared (NIR) method was developed for determination of tablet potency of active pharmaceutical ingredient (API) in a complex coated tablet matrix. The calibration set contained samples from laboratory and production scale batches. The reference values were obtained by high performance liquid chromatography (HPLC) and partial least squares (PLS) regression was used to establish a model. The model was challenged by calculating tablet potency of two external test sets. Root mean square errors of prediction were respectively equal to 2.0% and 2.7%. To use this model with a second spectrometer from the production field, a calibration transfer method called piecewise direct standardisation (PDS) was used. After the transfer, the root mean square error of prediction of the first test set was 2.4% compared to 4.0% without transferring the spectra. A statistical technique using bootstrap of PLS residuals was used to estimate confidence intervals of tablet potency calculations. This method requires an optimised PLS model, selection of the bootstrap number and determination of the risk. In the case of a chemical analysis, the tablet potency value will be included within the confidence interval calculated by the bootstrap method. An easy to use graphical interface was developed to easily determine if the predictions, surrounded by minimum and maximum values, are within the specifications defined by the regulatory organisation.

28 citations

Journal ArticleDOI
TL;DR: A single administration of a supratherapeutic dose of tianeptine does not induce psychostimulant effect in young healthy volunteers in contrast to methylphenidate at a therapeutic dose, suggesting an absence of psychostIMulant liability of tIANeptine in a therapeutic situation.
Abstract: Objective: The primary objective of the present study was to assess the potential psychostimulant effect of a single oral supratherapeutic dose of tianeptine (75 mg in 1 shot) in young healthy volunteers compared with methylphenidate (40 mg) and placebo. Method: Eighteen healthy young male and female volunteers with no history of psychostimulant abuse completed this balanced, crossover, placebo-controlled study. Subjective and behavioral effects were assessed before treatment and 1, 2, 3, 4, and 8 hours after drug intake. Subjective effects of the drugs were recorded using self-questionnaire Addiction Research Center Inventory (ARCI 49). In addition, the Profile of Mood Scale, Visual Analog Scale, and attention/vigilance tests (choice reaction time and critical flicker fusion test) were used to evaluate mood state, subjective feeling, and sustained attention, respectively. Results: Analysis on changes from baseline, from 1 to 8 hours, showed statistically significant differences between treatment groups for 2 of the 5 ARCI subscales: amphetamine and morphine benzedrine scales. A trend to significance was observed for Lysergic Acid Diethylamide scale. Indeed, although tianeptine did not significantly change any ARCI scores, methylphenidate significantly increased amphetamine and morphine benzedrine scores of the ARCI compared with placebo. No significant treatment effect was observed on the Profile of Mood Scale and the visual analog scale. Analyses of attention and vigilance tests showed a psychostimulant effect for methylphenidate on choice reaction time (decrease of recognition time) and critical flicker fusion test (higher frequency). Conclusions: A single administration of a supratherapeutic dose of tianeptine does not induce psychostimulant effect in young healthy volunteers in contrast to methylphenidate at a therapeutic dose. These findings suggest an absence of psychostimulant liability of tianeptine in a therapeutic situation.

15 citations

Patent
29 Mar 2001
Abstract: Synthesis of 11-amino-3-chloro-6,11-dihydro-5,5-dioxo-6-methyl dibenzo(c,f)(1,2)thiazepine (I) and its salts, from 3-chloro-6,11-dihydro-6-methyl-5,5,11-trioxo dibenzo(c,f)(1,2)thiazepine (III). Synthesis of 11-amino-3-chloro-6,11-dihydro-5,5-dioxo-6-methyl dibenzo(c,f)(1,2)thiazepine of formula (I) and its salts, from 3-chloro-6,11-dihydro-6-methyl-5,5,11-trioxo dibenzo(c,f)(1,2)thiazepine of formula (III): Independent claims are also included for the use of (I) to prepare tianeptine (II) and its salts.

13 citations

Journal ArticleDOI
TL;DR: The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information, and the technical requirements, the implementation by different countries and the practicalities are discussed.
Abstract: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format has now become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. Derivatives of the CTD are becoming widely adopted in other regions, including the ASEAN countries. An electronic CTD (eCTD) was developed in parallel with the CTD and the three ICH regions now accept eCTD filings. The purpose of this article is to survey the eCTD technical requirements, the implementation by different countries and to discuss some of the practicalities involved in writing, compiling and publishing eCTD applications. The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information. The eCTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the eCTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the need for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. Regulatory agencies are moving to accept online filings, but these are currently commonly made using physical media such as CD, DVD or tape. The eCTD file needs to be ‘reviewer friendly’ by use of bookmarks, hyperlinking and tables of contents in individual documents. Prescriber and patient information can now be supplied electronically using the XML-based EU PIM Data Exchange Standard and the Structured Product Labelling in the US. Many commercial software tools are available for content management, assembly, compilation, publishing, labelling, electronic validation and review. eCTDs can be developed using leased or purchased software, specialist contract services, outsourcing from software vendors or using contract research organisations.

5 citations