�ݺ�ߣshows by User: AkankshaKamble6

�ݺ�ߣshows by User: AkankshaKamble6 / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: AkankshaKamble6 / Sun, 07 Jan 2024 14:49:54 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: AkankshaKamble6 CTD & eCTD /slideshow/ctd-ectd-4de2/265200716 ctdectd-240107144954-b443b994
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States. Module 1: Administrative information and prescribing information for Australia Module 2: Common technical document summaries Module 2 summarises the information that will be provided in the quality (Module 3), nonclinical (Module 4) and clinical (Module 5) modules of the dossier. 2.1 Common technical document table of contents (Modules 2–5) 2.2 CTD introduction 2.3 Quality overall summary 2.4 Nonclinical overview 2.5 Clinical overview 2.6 Nonclinical written and tabulated summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical summary Clinical pharmacology studies Clinical efficacy Clinical safety Literature references Module 3: Quality 3.1 Module 3 table of contents 3.2 Body of data 3.3 Literature references Module 4: Safety (nonclinical study reports) 4.1 Module 4 table of contents 4.2 Study reports 4.3 Literature references Module 5: Efficacy (clinical study reports) 5.1 Module 5 table of contents 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 5.4 Literature references]]>
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States. Module 1: Administrative information and prescribing information for Australia Module 2: Common technical document summaries Module 2 summarises the information that will be provided in the quality (Module 3), nonclinical (Module 4) and clinical (Module 5) modules of the dossier. 2.1 Common technical document table of contents (Modules 2–5) 2.2 CTD introduction 2.3 Quality overall summary 2.4 Nonclinical overview 2.5 Clinical overview 2.6 Nonclinical written and tabulated summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical summary Clinical pharmacology studies Clinical efficacy Clinical safety Literature references Module 3: Quality 3.1 Module 3 table of contents 3.2 Body of data 3.3 Literature references Module 4: Safety (nonclinical study reports) 4.1 Module 4 table of contents 4.2 Study reports 4.3 Literature references Module 5: Efficacy (clinical study reports) 5.1 Module 5 table of contents 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 5.4 Literature references]]> Sun, 07 Jan 2024 14:49:54 GMT /slideshow/ctd-ectd-4de2/265200716 AkankshaKamble6@slideshare.net(AkankshaKamble6) CTD & eCTD AkankshaKamble6 The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States. Module 1: Administrative information and prescribing information for Australia Module 2: Common technical document summaries Module 2 summarises the information that will be provided in the quality (Module 3), nonclinical (Module 4) and clinical (Module 5) modules of the dossier. 2.1 Common technical document table of contents (Modules 2–5) 2.2 CTD introduction 2.3 Quality overall summary 2.4 Nonclinical overview 2.5 Clinical overview 2.6 Nonclinical written and tabulated summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical summary Clinical pharmacology studies Clinical efficacy Clinical safety Literature references Module 3: Quality 3.1 Module 3 table of contents 3.2 Body of data 3.3 Literature references Module 4: Safety (nonclinical study reports) 4.1 Module 4 table of contents 4.2 Study reports 4.3 Literature references Module 5: Efficacy (clinical study reports) 5.1 Module 5 table of contents 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 5.4 Literature references <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ctdectd-240107144954-b443b994-thumbnail.jpg?width=120&height=120&fit=bounds" /><br> The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities. The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States. Module 1: Administrative information and prescribing information for Australia Module 2: Common technical document summaries Module 2 summarises the information that will be provided in the quality (Module 3), nonclinical (Module 4) and clinical (Module 5) modules of the dossier. 2.1 Common technical document table of contents (Modules 2–5) 2.2 CTD introduction 2.3 Quality overall summary 2.4 Nonclinical overview 2.5 Clinical overview 2.6 Nonclinical written and tabulated summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical summary Clinical pharmacology studies Clinical efficacy Clinical safety Literature references Module 3: Quality 3.1 Module 3 table of contents 3.2 Body of data 3.3 Literature references Module 4: Safety (nonclinical study reports) 4.1 Module 4 table of contents 4.2 Study reports 4.3 Literature references Module 5: Efficacy (clinical study reports) 5.1 Module 5 table of contents 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 5.4 Literature references

CTD & eCTD from AkankshaKamble6

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0 Polymers, Ideal properties, Classification/Types, Applications /slideshow/polymers-ideal-properties-classificationtypes-applications/265199440 polymers-240107134035-a38542a4
POLYMERS Introduction: It is synonym for Plastic. Also known as Macromolecules. The word ‘polymer’ comes from Greek words: polymeros Poly means ‘many’ and ‘mer’ means ‘parts’. These are very large molecules consisting of many repeating units called monomers [small molecules] and are formed by a process called polymerization. In other words, polymers are very large molecules made when 100’s of monomers join together to form long chains. Ideal Properties: 1. It should be inert. 2. It should be non-toxic. 3. It should be compatible with environment. 4. It should be easy to fabricate and inexpensive. 5. It should be biodegradable and biocompatible. 6. It should provide good drug polymer linkage. Classification of Polymers 1. Based on the Source of Availability There are three types of classification under this category, namely, natural, synthetic, and semi-synthetic polymers. a. Natural Polymers They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose and rubber. To add up, we also have biodegradable polymers called biopolymers. b. Semi-synthetic Polymers They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate and cellulose acetate. c. Synthetic Polymers These are human-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether, etc. 2. Based on the Structure of the Monomer Chain: a. Linear Polymers The structure of polymers containing long and straight chains falls into this category. PVC, i.e., polyvinyl chloride, is largely used for making pipes, and an electric cable is an example of a linear polymer. b. Branched-chain Polymers When linear chains of a polymer form branches, then such polymers are categorized as branched chain polymers. For example, low-density polythene. c. Cross-linked Polymers They are composed of bifunctional and trifunctional monomers. They have a stronger covalent bond in comparison to other linear polymers. Bakelite and melamine are examples of cross-linked polymers. 3. Classification Based on Polymerization a. Addition Polymerization: For example, poly ethane, Teflon, polyvinyl chloride (PVC), etc. b. Condensation Polymerization: Eg include nylon -6, 6, perylene, polyesters, etc. 4.Classification Based on Monomers a. Homomer: In this type, a single type of monomer unit is present. Eg, polyethene. b. Heteropolymer or co-polymer: It consists of different types of monomer units. Eg, nylon -6, 6. 5.Classification Based on Molecular Forces a. Elastomers: These are rubber-like solids, and weak interaction forces are present in them. Eg, rubber. b. Thermoplastics: These have intermediate forces of attraction. eg polyvinyl chloride. c. Thermosetting polymers: These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. Eg silicones, phenolics.]]>
POLYMERS Introduction: It is synonym for Plastic. Also known as Macromolecules. The word ‘polymer’ comes from Greek words: polymeros Poly means ‘many’ and ‘mer’ means ‘parts’. These are very large molecules consisting of many repeating units called monomers [small molecules] and are formed by a process called polymerization. In other words, polymers are very large molecules made when 100’s of monomers join together to form long chains. Ideal Properties: 1. It should be inert. 2. It should be non-toxic. 3. It should be compatible with environment. 4. It should be easy to fabricate and inexpensive. 5. It should be biodegradable and biocompatible. 6. It should provide good drug polymer linkage. Classification of Polymers 1. Based on the Source of Availability There are three types of classification under this category, namely, natural, synthetic, and semi-synthetic polymers. a. Natural Polymers They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose and rubber. To add up, we also have biodegradable polymers called biopolymers. b. Semi-synthetic Polymers They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate and cellulose acetate. c. Synthetic Polymers These are human-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether, etc. 2. Based on the Structure of the Monomer Chain: a. Linear Polymers The structure of polymers containing long and straight chains falls into this category. PVC, i.e., polyvinyl chloride, is largely used for making pipes, and an electric cable is an example of a linear polymer. b. Branched-chain Polymers When linear chains of a polymer form branches, then such polymers are categorized as branched chain polymers. For example, low-density polythene. c. Cross-linked Polymers They are composed of bifunctional and trifunctional monomers. They have a stronger covalent bond in comparison to other linear polymers. Bakelite and melamine are examples of cross-linked polymers. 3. Classification Based on Polymerization a. Addition Polymerization: For example, poly ethane, Teflon, polyvinyl chloride (PVC), etc. b. Condensation Polymerization: Eg include nylon -6, 6, perylene, polyesters, etc. 4.Classification Based on Monomers a. Homomer: In this type, a single type of monomer unit is present. Eg, polyethene. b. Heteropolymer or co-polymer: It consists of different types of monomer units. Eg, nylon -6, 6. 5.Classification Based on Molecular Forces a. Elastomers: These are rubber-like solids, and weak interaction forces are present in them. Eg, rubber. b. Thermoplastics: These have intermediate forces of attraction. eg polyvinyl chloride. c. Thermosetting polymers: These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. Eg silicones, phenolics.]]> Sun, 07 Jan 2024 13:40:34 GMT /slideshow/polymers-ideal-properties-classificationtypes-applications/265199440 AkankshaKamble6@slideshare.net(AkankshaKamble6) Polymers, Ideal properties, Classification/Types, Applications AkankshaKamble6 POLYMERS Introduction: It is synonym for Plastic. Also known as Macromolecules. The word ‘polymer’ comes from Greek words: polymeros Poly means ‘many’ and ‘mer’ means ‘parts’. These are very large molecules consisting of many repeating units called monomers [small molecules] and are formed by a process called polymerization. In other words, polymers are very large molecules made when 100’s of monomers join together to form long chains. Ideal Properties: 1. It should be inert. 2. It should be non-toxic. 3. It should be compatible with environment. 4. It should be easy to fabricate and inexpensive. 5. It should be biodegradable and biocompatible. 6. It should provide good drug polymer linkage. Classification of Polymers 1. Based on the Source of Availability There are three types of classification under this category, namely, natural, synthetic, and semi-synthetic polymers. a. Natural Polymers They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose and rubber. To add up, we also have biodegradable polymers called biopolymers. b. Semi-synthetic Polymers They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate and cellulose acetate. c. Synthetic Polymers These are human-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether, etc. 2. Based on the Structure of the Monomer Chain: a. Linear Polymers The structure of polymers containing long and straight chains falls into this category. PVC, i.e., polyvinyl chloride, is largely used for making pipes, and an electric cable is an example of a linear polymer. b. Branched-chain Polymers When linear chains of a polymer form branches, then such polymers are categorized as branched chain polymers. For example, low-density polythene. c. Cross-linked Polymers They are composed of bifunctional and trifunctional monomers. They have a stronger covalent bond in comparison to other linear polymers. Bakelite and melamine are examples of cross-linked polymers. 3. Classification Based on Polymerization a. Addition Polymerization: For example, poly ethane, Teflon, polyvinyl chloride (PVC), etc. b. Condensation Polymerization: Eg include nylon -6, 6, perylene, polyesters, etc. 4.Classification Based on Monomers a. Homomer: In this type, a single type of monomer unit is present. Eg, polyethene. b. Heteropolymer or co-polymer: It consists of different types of monomer units. Eg, nylon -6, 6. 5.Classification Based on Molecular Forces a. Elastomers: These are rubber-like solids, and weak interaction forces are present in them. Eg, rubber. b. Thermoplastics: These have intermediate forces of attraction. eg polyvinyl chloride. c. Thermosetting polymers: These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. Eg silicones, phenolics. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/polymers-240107134035-a38542a4-thumbnail.jpg?width=120&height=120&fit=bounds" /><br> POLYMERS Introduction: It is synonym for Plastic. Also known as Macromolecules. The word ‘polymer’ comes from Greek words: polymeros Poly means ‘many’ and ‘mer’ means ‘parts’. These are very large molecules consisting of many repeating units called monomers [small molecules] and are formed by a process called polymerization. In other words, polymers are very large molecules made when 100’s of monomers join together to form long chains. Ideal Properties: 1. It should be inert. 2. It should be non-toxic. 3. It should be compatible with environment. 4. It should be easy to fabricate and inexpensive. 5. It should be biodegradable and biocompatible. 6. It should provide good drug polymer linkage. Classification of Polymers 1. Based on the Source of Availability There are three types of classification under this category, namely, natural, synthetic, and semi-synthetic polymers. a. Natural Polymers They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose and rubber. To add up, we also have biodegradable polymers called biopolymers. b. Semi-synthetic Polymers They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate and cellulose acetate. c. Synthetic Polymers These are human-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether, etc. 2. Based on the Structure of the Monomer Chain: a. Linear Polymers The structure of polymers containing long and straight chains falls into this category. PVC, i.e., polyvinyl chloride, is largely used for making pipes, and an electric cable is an example of a linear polymer. b. Branched-chain Polymers When linear chains of a polymer form branches, then such polymers are categorized as branched chain polymers. For example, low-density polythene. c. Cross-linked Polymers They are composed of bifunctional and trifunctional monomers. They have a stronger covalent bond in comparison to other linear polymers. Bakelite and melamine are examples of cross-linked polymers. 3. Classification Based on Polymerization a. Addition Polymerization: For example, poly ethane, Teflon, polyvinyl chloride (PVC), etc. b. Condensation Polymerization: Eg include nylon -6, 6, perylene, polyesters, etc. 4.Classification Based on Monomers a. Homomer: In this type, a single type of monomer unit is present. Eg, polyethene. b. Heteropolymer or co-polymer: It consists of different types of monomer units. Eg, nylon -6, 6. 5.Classification Based on Molecular Forces a. Elastomers: These are rubber-like solids, and weak interaction forces are present in them. Eg, rubber. b. Thermoplastics: These have intermediate forces of attraction. eg polyvinyl chloride. c. Thermosetting polymers: These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. Eg silicones, phenolics.

Polymers, Ideal properties, Classification/Types, Applications from AkankshaKamble6

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