Spectrophotometry and pharmaceutical PAT/RTRT: Practical challenges and regulatory landscape from development to product lifecycle.

European Pharmacopoeia includes dedicated chapters for Raman, NIR and Chemometrics, as well as there is a lot of Academia research on the matter. Despite that, the word innovation is often associated to such tools and there is a still slow implementation at industry. The paper is the outcome of the Associazione Farmaceutici dell'Industria (AFI) Study Group on Process Innovation and Product Lifecycle; the aim is to describe some case studies referring to practical approaches in pharmaceutical industry, in order to depict challenges and opportunities for the implementation of spectroscopic techniques.

"Aquabeam® System" for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.

Purpose: Aim of this systematic review is to evaluate functional outcomes (Qmax, QoL, IPSS, PVR), sexual outcome (erectile dysfunction and anejaculation rate), and adverse events evaluated according to the Clavien-Dindo classification.

Methods: The bibliographic search with the included terms (prostate, benign prostatic hyperplasia, benign prostatic enlargement, lower urinary tract symptoms, water jet dissection, aquablation, Aquabeam®) produced a literature of 32 articles altogether. After removing papers of not interest or articles which the outcomes could not be deduced, nine studies were examined for a total of 664 patients screened.

The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.

Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain.

Managing Caesarean Scar Pregnancy in low Resource Settings: 2 Case Reports and a Description of Transrectal Ultrasound guided Surgical Approach (TRUGA).

Caesarean scar pregnancy (CSP) occurs when an embryo implants in a previous caesarean section scar. It has a reported incidence of 1 in 1800. Various surgical and medical techniques have been described in case reports for the management of CSP.

Drug delivery system innovation and Health Technology Assessment: Upgrading from Clinical to Technological Assessment.

Health Technology Assessment (HTA) is a multidisciplinary health political instrument that evaluates the consequences, mainly clinical and economical, of a health care technology; the HTA aim is to produce and spread information on scientific and technological innovation for health political decision making process. Drug delivery systems (DDS), such as nanocarriers, are technologically complex but they have pivotal relevance in therapeutic innovation. The HTA process, as commonly applied to conventional drug evaluation, should upgrade to a full pharmaceutical assessment, considering the DDS complexity.