Overview

Inamed is known for its respiratory expertise, which goes far beyond just conducting clinical studies in patients with respiratory indications. In order to support the planning and conduct of its wide variety of clinical studies Inamed has established a highly qualified team of of scientific, engineering, and medical experts, enabling interdisciplinary collaboration between the department, leading to synergistic effects, which results in higher quality data.

Moreover in order to provide its clients with high quality data and low variability, which can be quite a challange with inhalable drugs, Inamed has integrated special subject training approaches.

Early Phase Clinical Trials

The continuous monitoring of safety parameters (e.g., pulse rate, 3-lead ECG, oxygen saturation in peripheral blood) in combination with an alarm system and storage of data is nowadays mandatory for certain studies in early clinical development, e.g., First-in-Man (FIM) trials.

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FIM Trials as a very special type of early clinical safety trials are mentioned above, but there are more questions that might have to be answered in dedicated safety studies in healthy subjects or patients.

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Inamed’s clinical pharmacology experts and CU staff has a special expertise in conducting TQT trials. Background: A drug-induced delay in cardiac repolarisation can lead to cardia arrhythmia.

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The clinical facilities and infrastructure of Inamed’s clinical unit are appropriately staffed and equipped to conduct all kind of pharmacokinetic (PK) trials. Dedicated laboratory facilities, temperature-controlled working rooms, refrigerators and deep freezers connected with alarm systems and an emergency power generator are also available.

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DDI trials are special PK trials. Background: Drug-drug interactions can occur at any of the following levels: absorption, distribution, binding at the receptor, metabolization, or elimination. Clinically relevant interactions may occur as a result of induction or inhibition of an enzyme system by a certain drug, while another substrate is being metabolized via that enzyme system.

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In early clinical development, the term “large-scale trials” refers to mono-centre trials with a sample size of more than 80 subjects. The combination of Inamed’s in-house clinical unit with an outpatient clinic for ambulant visits and the company’s human resources pool allows the conduct of even large-scale trials within a reasonable period of time.

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Early Phase Clinical Trials in Patients

The first clinical trial in patients is always a safety study in a general sense. More specifically, a dedicated safety study in patients under highly controlled conditions may be required to investigate some special objectives.

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That kind of PK trials in patients is usually conducted to investigate whether the PK in patients is comparable to that in healthy subjects. Any differences in the pharmacokinetics of the investigational compound between patients and healthy subjects may either be caused by the pathophysiology of the disease, for example, in case of inflammation, or the metabolism or excretion of the study drug may be influenced by hepatic or renal impairment which is not the situation in healthy subjects.

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Proof-of-Concept trials in patients using adequate pharmacodynamic endpoints should not be initiated before an adequate phase-I program has been completed in healthy subjects and all safety and exposure data in healthy subjects have been thoroughly reviewed.

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Clinical Trials for Generic Companies

Be it in healthy volunteers or patients, be it bioequivalence according to EMA requirements or therapeutic equivalence according to FDA requrements, Inamed is exaclty the right partner for your equivalence trials.

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