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Development of Topical and Transdermal Dosage Forms
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
The principles described in the ICH Q8 guidelines25 and a quality by design (QbD) approach to drug development are highly recommended. A detailed pharmaceutical development report is recommended to be submitted to the NDA outlining the justification for the chosen processing options, product and process development, critical quality attributes, critical process parameters and scientific approach to process scale-up based on product and process understanding. Pharmaceutical development information is submitted in Section P.2 of the CTD (Common Technical Document). Other information resulting from pharmaceutical development studies could be accommodated by the CTD format in a number of different ways and some specific suggestions are provided later. However, the applicant should clearly indicate where the different information is located. In addition to what is submitted in the application, certain aspects (e.g., product life cycle management, continual improvement) of this guideline are handled under the applicant’s pharmaceutical quality system.
The European Union Regulatory Scene
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Steven C. Nichols, Dennis Sandell
If one is developing a “generic” OIP within the EU, then either a hybrid application or an abridged application [7,8] can be made. The former usually occurs when bioequivalence cannot be demonstrated through bioavailability studies. In the latter case, complete quality data (module 3 of the Common Technical Document [CTD]), appropriate preclinical (module 4), and clinical data (module 5) are required. We shall discuss generic OIPs further later. Guidance on MAAs can be found in “The Rules Governing Medicinal Products”—Notice to applicants Volume 2A (Chapter 1).
Overview of Drug Development
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
James A. Popp, Jeffery A. Engelhardt
One additional area of harmonization was in the format and content of the marketing application called the Common Technical Document (CTD). The CTD is the dossier containing all critical and supportive information on the nonclinical, manufacturing, and clinical development of the candidate drug presented in such a way as to facilitate the assessment of the data by the reviewing health authorities. Full details of the CTD can also be found on the ICH website (www.ich.org/products/ctd.html). With respect to the nonclinical portion of the CTD, there are three main sections where the data are housed and summarized. Briefly, Module 4 (Safety) contains the individual study reports, including all individual animal data. Module 2.6 contains the textual and tabular summaries for the individual reports, and Module 2.4 contains the integrated nonclinical overview. Each of the modules builds an integrated and interpretive data pyramid that, hopefully, facilitates the review, understanding, and assessment of the data contained in the in vitro and in vivo studies.
WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?
Published in Expert Review of Clinical Pharmacology, 2022
Alexandra Vaz, Mariana Roldão Santos, Luther Gwaza, Elena Mezquita González, Magdalena Pajewska Lewandowska, Samvel Azatyan, Agnès Saint-Raymond
The SRA CRP pilot was initiated in 2015. It uses the regulatory expertise of SRAs to facilitate and accelerate the national regulatory assessments and approvals of medicines (including small molecules, biologicals, generics, biosimilars, and vaccines) [2,8]. The procedure is applicable to any of these medicines when previously assessed and/or approved by an SRA and when they represent public health needs, including medicines that are not in the scope of WHO prequalification. The only condition is that the medicine has a positive scientific opinion (including EU-M4all opinions), or an approval granted by an SRA. The pharmaceutical company (sponsor or applicant) may submit the same dossier, using the ICH common technical document (CTD) format, to several National Regulatory Authorities (NRAs). Participation in CRP is voluntary and details on information sharing, management of confidentiality, timeframes and other requirements are described in the guideline of the procedure [8] as well as on WHO website [9].
The significance of drug-to-lipid ratio to the development of optimized liposomal formulation
Published in Journal of Liposome Research, 2018
Maria Chountoulesi, Nikolaos Naziris, Natassa Pippa, Costas Demetzos
The aim of this study is to describe the important role that D/L ratio exhibits at rational design and development of liposomal formulations, being a critical parameter that has to be investigated, from the preformulation studies to the clinical studies of novel liposomal products. It is worth to note that variations of this ratio could affect the release profile of the loaded drug and consequently its effectiveness. (Johnston et al., 2008). Moreover, the stability of the final liposomal product should be correlated with the variability of D/L ratio in different liposomal formulations and should be investigated. The approach to investigate and evaluate the D/L ratio of liposomal formulations could be considered as a bacon to the evaluation process of nanosimilars and to fulfill the correspond module in the Common Technical Document (CTD) to be submitted to the regulatory agencies.
Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices
Published in Expert Review of Clinical Pharmacology, 2022
Tariro Sithole, Sam Salek, Gugu Mahlangu, Stuart Walker
All five agencies require the full modules 1 to 5 of the Common Technical Document format; that is, chemistry, manufacturing and control (CMC), non-clinical and clinical data as well as summaries, regardless of the review model used. An extensive assessment of all the sections is conducted under the full review model. The review of the quality, safety and efficacy data is done in parallel by four of the agencies, whereas MCAZ reviews these sections sequentially for all products excluding biosimilars [20]. Pricing negotiations are separate from the technical review in all the five agencies; however, in Australia and Canada, there is an option for health technology assessments to be conducted in parallel with the regulatory review.