GÜNCELLEŞTİRİLMİŞ CTD ÖN İNCELEME DEĞERLENDİRME FORMU

 

Ürün Adı :

Başvuru Türü :

Ürün Etkin Maddesinin Veri Koruma Değerlendirilmesi :

Başvuru Sahibi :

Üretim Yeri :

Dozlar :

Farmasötik Formu :

Etkin Maddeler :

Başvuru Adına İletişimden Sorumlu Kişi :

Başvuru Tarihi :

Ön İnceleme Bitiş Tarihi :

Ruhsat Başvuruları İçin Dosya İçeriği

                                                                                                                                  TAM                      EKSİK

  MODÜL 1: İDARİ BİLGİLER

 

1.1 İÇİNDEKİLER (Modül 1 ve 5)                                                                                                      

Her Modül Kendi İçinde Numaralandırılmış Mı ?     

 

1.2 BAŞVURU FORMU                                                                                                                       

(Ekteki Başvuru Formu Doldurulduktan Sonra Yukarıdaki Kısıma Check Atılacaktır)

1.3 ÜRÜN BİLGİSİ                                                                                                          

            1.3.1 KÜB                                                                                                                                    

Ambalaj(İç-dış amb. üzerinde yer alacak bilgiler)                                                               

Etiket                                                                                                                                   

Kullanma Talimatı                                                                                                               

            1.3.2 Taslaklar                                                                                                                                                                                              

            1.3.3 Örnekler/Taslaklar                                                                                                                

            1.3.4 Okunabilirlik Testi                                                                                                               

            1.3.5 Halen Varsa Diğer Ülkelerde Onaylamış KÜB (geçerli olduğunda)                                  

                                                                                                                                  TAM                      EKSİK

1.4 UZMANLAR HAKKINDA BİLGİLER

            1.4.1 Kalite (Uzmanın Adı, Adresi, İmzası, Özgeçmişi)                                                              

            1.4.2 Klinik Dışı (Uzmanın Adı, Adresi, İmzası, Özgeçmişi)                                                              

            1.4.3 Klinik (Uzmanın Adı, Adresi, İmzası, Özgeçmişi)                                                             

 

1.5 DEĞİŞİK TİPTE BAŞVURULAR İÇİN ÖZEL GEREKLER

            1.5.1 Bibliyografik Başvurulara İlişkin Bilgi                                                                    

            1.5.2 Kısaltılmış Başvurulara İlişkin Bilgi                                                                                    

 

1.6 ÇEVRESEL RİSK DEĞERLENDİRİLMESİ

            1.6.1 Non-GDO (Genetiği Değiştirilmemiş Organizmalar)                                                             

            1.6.2 GDO (Genetiği Değiştirilmiş Organizmalar)                                                                       

 

MODÜL 2: ÖZETLER

2. 1. İÇİNDEKİLER TABLOSU (Modül 2 – 5)                                                                                  

2. 2. GİRİŞ                                                                                                                                              

2. 3. GENEL KALİTE ÖZETİ

         GİRİŞ                                                                                                                                            

        2.3.S ETKİN MADDE (İsim, imalatçı)                                                       

                        2.3.S.1 Genel Bilgi (İsim, imalatçı)                                                                                  

                        2.3.S.2 İmalat (İsim, imalatçı)                                                                                          

                        2.3.S.3 Tanımlama (İsim, imalatçı)                                                                                   

                        2.3.S.4 Etkin Maddenin Kontrolü (İsim, imalatçı)                                                                                           2.3.S.5 Referans Standart ve Materyaller (İsim, imalatçı)                                             

                        2.3.S.6 Kap-Kapak Sistemi (İsim, imalatçı)                                                                     

                        2.3.S.7 Stabilite (İsim, imalatçı)                                                                                       

 

                                                                                                                                  TAM                      EKSİK

2.3.P TIBBİ ÜRÜN (İsim, dozaj formu)

                        2.3.P.1 İlaç Ürününün Tanımı ve Bileşimi (İsim, dozaj formu)                                        

                        2.3.P.2 Farmasötik Geliştirme (İsim, dozaj formu)                                                           

                        2.3.P.3 İmalat (İsim, dozaj formu)                                                                                    

                        2.3.P.4 Yardımcı Maddelerin Kontrolü (İsim, dozaj formu)                                                        

                        2.3.P.5 Tıbbi Ürünlerin Kontrolü (İsim, dozaj formu)                                                      

                        2.3.P.6 Referans Standart ve Materyaller (İsim, dozaj formu)                                         

                        2.3.P.7 Kap-Kapak Sistemi (İsim, dozaj formu)                                                               

                        2.3.P.8 Stabilite (İsim, dozaj formu)(Stabilite protokolü)                                                

2.3.A EKLER          

                        2.3.A.1 Tesisler ve Donanım (İsim, imalatçı)                                                                    

                        2.3.A.2 Adventisyel Ajanların Güvenirlilik Değerlendirilmesi                                        

                                    (İsim, dozaj formu, imalatçı)                                                

                        2.3.A.3 Yardımcı Maddeler                                                                                             

2.3.R BÖLGESEL BİLGİ                                                                                                         

            *Etkin madde uygunluk sertifikaları(CEP), insan veya hayvansal kaynaklı madde

            kullanılmadığına dair beyan, kullanılmış ise TSE/BSE belgesi

2. 4. KLİNİK DIŞI GENEL BAKIŞ                                                                                                    

2. 5. KLİNİK GENEL BAKIŞ

            İÇİNDEKİLER                                                                                                                           

            2.5.1 Ürün Geliştirme Gerekçesi                                                                                                  

            2.5.2 Biyofarmasötik Genel Özeti                                                                                                

            2.5.3 Klinik Farmakoloji Genel Özeti                                                                                          

            2.5.4 Etkinlik Genel Özeti                                                                                                            

            2.5.5 Güvenilirlik Genel Özeti                                                                                                     

            2.5.6 Yararlar ve Risklere İlişkin Varılan Sonuçlar                                                                      

            2.5.7 Referanslar (Liste halinde)                                                                                                  

2. 6. KLİNİK DIŞI YAZILI VE ÇİZELGELİ ÖZET

            2.6.1 Giriş                                                                                                                                             

            2.6.2 Yazılı Farmakolojik Özet                                                                   

                        2.6.2.1 Kısa özet                                                                                                               

 

                                                                                                                                 TAM                      EKSİK

2.6.2.2 Primer Farmakodinami                                                                                         

                        2.6.2.3 Sekonder Farmakodinami                                                                                     

                        2.6.2.4 Farmakolojik Güvenilirlik                                                                                     

                        2.6.2.5 Farmakodinamik İlaç Etkileşimleri                                                                       

                        2.6.2.6 Tartışma ve sonuç                                                                                                 

                        2.6.2.7 Tablolar ve Şekiller                                                                                               

            2.6.3 Çizelgeli Farmakolojik Özet (Bölümün tamamı tablo şeklinde)                                 

                        2.6.3.1 Farmakoloji: Genel Özet                                                                                       

                        2.6.3.2 Primer Farmakodinami                                                                                         

                        2.6.3.3 Sekonder Farmakodinami                                                                                     

                        2.6.3.4 Farmakolojik Güvenirlilik                                                                                     

                        2.6.3.5 Farmakodinamik İlaç Etkileşimleri                                                                       

            2.6.4 Yazılı Farmakokinetik Özet                                                               

                        2.6.4.1 Kısa Özet                                                                                                                             

                        2.6.4.2 Analiz Yöntemleri                                                                                                

                        2.6.4.3 Emilim                                                                                                                  

                        2.6.4.4 Dağılım                                                                                                                 

                        2.6.4.5 Metabolizma                                                                                                         

                        2.6.4.6Atılım                                                                                                                     

                        2.6.4.7 Farmakokinetik İlaç Etkileşimleri                                                                         

                        2.6.4.8 Diğer Farmakokinetik Araştırmalar                                                                      

                        2.6.4.9 Tartışma ve Sonuç                                                                                                

                        2.6.4.10 Tablolar ve Şablonlar                                                                                          

            2.6.5 Çizelgeli Farmakolojik Özet (Bölümün tamamı tablo şeklinde)                                                        

                        2.6.5.1 Farmakokinetik: Genel Özet                                                                                 

                        2.6.5.2 Analitik Yöntem ve Validasyon Raporları                                                           

                        2.6.5.3 Farmakokinetik:Tek Dozdan Sonra Emilim                                                                 

                        2.6.5.4 Farmakokinetik: Tekrarlanan Dozlardan Sonra Emilim                                        

                        2.6.5.5 Farmakokinetik: Organ Dağılımı                                                                          

                        2.6.5.6 Farmakokinetik: Plazma Proteinlerine Bağlanma                                                 

2.6.5.7 Farmakokinetik: Gebe ve Emziren Hayvanlarda Araştırma                                 

2.6.5.8 Farmakokinetik: Diğer Dağılım Araştırmaları         

                                             

Diğer Bağlantılar