Study medications/devices preparation

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

Requisition of study medication/device (including placebo and comparator products, if relevant) must be initiated at an early stage to allow sufficient time to procure the study medications/devices and to prepare the final labeling and packaging, taking into account any special circumstances for blind studies and for import requirements. 

Generally, destruction of returned study medications/devices by the sponsor/CRO may not take place until the final report has been prepared and until there is no further reason to question the accountability of the study medication/device. The actual destruction process must be documented in a manner which clearly details the final disposition of the unused medications/devices and the method of destruction. The information is particularly necessary in case of any query regarding environmental impact. In exceptional circumstances, unused study medications (e.g. cytotoxics, radio-labeled products) may be destroyed at the study site, with appropriate documentation. 

As mentioned previously (and discussed in detail in Sec. IX), contact lens products have specific guidelines that focus on compatibility with the contact lens and biocompatibility with the cornea and conjunctiva [75], These solutions are viewed as new medical devices and require testing with the contact lenses with which they are to be used. Tests include a 21-day ocular study in rabbits and employ the appropriate types of contact lenses with which they are to be used and may include the other solutions that might be used with the lens. Additional tests to evaluate cytotoxicity potential, acute toxicity, sensitization potential (allergenicity), and risks specific to the preparation are also required [75-77], These tests are sufficient to meet requirements in the majority of countries, though testing requirements for Japan are currently much more extensive. 

The preparation of study medications or devices for clinical studies is a time-consuming process and often rate-limiting in initiating the study, particularly with double-blind designs. Requisition, labeling and packaging are some of the important considerations. 

Li, D. Guo, G. Fan, R. Liang, J. Deng, X. Luo, F. Qian, Z. PLA/F68/Dexamethasone implants prepared by hot-melt extrusion for controlled release of anti-inflammatory drug to implantable medical devices I. Preparation, characterization and hydrolytic degradation study. Int. J. Pharm. 2013,447(1-2), 365-372. 

Self-assembled monolayers (SAMs) of alkanethiolates on metal surfaces constitute a class of molecular assemblies formed by the spontaneous chemisorption of long-chain functionalized molecules on the surface of solid substrates. Due to their ease of preparation, long-term stability, controllable surface chemical functionality, and high, crystal-like, two-dimensional order, SAMs represent suitable model surfaces to study molecular adsorption, adhesion, wetting, lubrication, and the interaction of proteins and cells with artificial organic surfaces. The latter phenomena are of crucial importance to the fields of biomaterials, biosensors, and medical devices. 

Poly(e-caprolactone) is prepared by the ring opening polymerisation of e-caprolactone. It has been widely studied as a matrix for controlled-release systems in a range of geometries. Poly( -caprolactone) degrades slower than polyhydroxy acids and is therefore preferred for controlled release devices with a longer life-time (a. 18). More recently an interest has been. shown in poly(e-caprolactone) as a medical device biomaterial (107, a. 19). 

Modification of polymer surfaces is used to improve biocompatibility or to provide medico-functionality of blood- and tissue-contacting medical devices. Yu et used Direct Laser Interference Patterning (DLIP) to prepare periodic micropatterns in polymers for study of contact guidance of mammalian cells. 

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