BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

147 related articles for article (PubMed ID: 36598646)

  • 1. The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA).
    Moeti L; Litedu M; Joubert J
    Pharmaceut Med; 2023 Jan; 37(1):71-91. PubMed ID: 36598646
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022.
    Moeti L; Litedu M; Joubert J
    J Pharm Policy Pract; 2023 Mar; 16(1):34. PubMed ID: 36864490
    [TBL] [Abstract][Full Text] [Related]  

  • 3. South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access.
    Keyter A; Salek S; Danks L; Nkambule P; Semete-Makokotlela B; Walker S
    Front Pharmacol; 2021; 12():699063. PubMed ID: 34366850
    [No Abstract]   [Full Text] [Related]  

  • 4. Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA).
    Moeti L; Litedu M; Joubert J
    Ther Innov Regul Sci; 2022 Sep; 56(5):822-838. PubMed ID: 35896784
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients' Access to Medicines.
    Keyter A; Salek S; Gouws J; Banoo S; Walker S
    Ther Innov Regul Sci; 2020 Jul; 54(4):878-887. PubMed ID: 32557310
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The South African Regulatory System: Past, Present, and Future.
    Keyter A; Banoo S; Salek S; Walker S
    Front Pharmacol; 2018; 9():1407. PubMed ID: 30618735
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland.
    Keyter A; Salek S; Banoo S; Walker S
    Front Pharmacol; 2019; 10():228. PubMed ID: 30923501
    [No Abstract]   [Full Text] [Related]  

  • 8. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.
    Keyter A; Gouws J; Salek S; Walker S
    Ther Innov Regul Sci; 2018 Jul; 52(4):449-458. PubMed ID: 29848046
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities.
    Danks L; Semete-Makokotlela B; Otwombe K; Parag Y; Walker S; Salek S
    Front Med (Lausanne); 2023; 10():1265058. PubMed ID: 37937144
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA).
    Moeti L; Litedu M; Joubert J
    J Pharm Policy Pract; 2022 Jan; 15(1):6. PubMed ID: 35022074
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.
    Happel AU; Singh R; Mitchev N; Mlisana K; Jaspan HB; Barnabas SL; Passmore JS
    BMC Infect Dis; 2020 Jul; 20(1):491. PubMed ID: 32650729
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA.
    Moeti L; Litedu M; Joubert J
    Ther Innov Regul Sci; 2022 Mar; 56(2):276-290. PubMed ID: 34859393
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Trends in the utilization of medicines sold in the private sector post- registration in South Africa and the implications for similar countries.
    Mpanza NM; Godman B; Keele MG; Matlala M
    BMC Public Health; 2023 Jan; 23(1):192. PubMed ID: 36709246
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality.
    Hashan HM; Al-Muteb SK; Alismail IA; Alsaleh ON; Alkherb ZM; McAuslane N; Walker SR
    Pharmaceut Med; 2022 Aug; 36(4):223-231. PubMed ID: 35767216
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
    Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P
    Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557
    [TBL] [Abstract][Full Text] [Related]  

  • 16. A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency.
    Keyter A; Salek S; Banoo S; Walker S
    Int J Health Policy Manag; 2022 Jun; 11(6):795-809. PubMed ID: 33300773
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward.
    Sithole T; Mahlangu G; Capote V; Sitoie T; Shifotoka S; Gaeseb J; Danks L; Nkambule P; Juma A; Fimbo A; Munkombwe Z; Mwale B; Salek S; Walker S
    Front Med (Lausanne); 2021; 8():742200. PubMed ID: 34513894
    [No Abstract]   [Full Text] [Related]  

  • 18. Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities.
    Thambavita D; Galappatthy P; Jayakody RL
    J Pharm Policy Pract; 2018; 11():14. PubMed ID: 29951208
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication?
    Keyter A; Salek S; Banoo S; Walker S
    Front Pharmacol; 2020; 11():855. PubMed ID: 32625087
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Collaborative reliance in medicine safety and quality regulation: Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries.
    Shabangu PP; Kuwana RJ; Dube A
    Front Med (Lausanne); 2022; 9():975032. PubMed ID: 36160156
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.