Introduction to Pre-Clinical Trials

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Introduction to Pre-Clinical Trials:

Introduction to Pre-Clinical Trials By- Gargi Nanda (Exam No. 1) Kirti Jadhav (Exam No. 2) M.Pharm - 1 (PT) Guided By- Madam Krutika Sawant

Overview:

Overview Drug Development Review Introduction Review By FDA Objectives Importance Goals Types Stages Of Preclinical Trials Introduction to Pre-Clinical Trials 2

Drug Development Review:

Drug Development Review Introduction to Pre-Clinical Trials 3

Introduction:

Introduction Pre-Clinical Trials is a study to test a drug, a procedure, or another medical treatment in animals. In drug development, pre-clinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data is collected. It also means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. Introduction to Pre-Clinical Trials 4

Introduction (Contd.):

Introduction (Contd.) We assume that In vitro assays predict in vivo effects The effects of chemicals in laboratory animals apply to humans The use of high doses in animals is valid for predicting possible toxicity in humans. These assumptions are broadly true, but despite this, we cannot be certain that a chemical will show no toxic effects in humans. Introduction to Pre-Clinical Trials 5

Preclinical Review by FDA:

Preclinical Review by FDA Under FDA requirements, a sponsor must first submit data showing that the drug is reasonably safe for use in initial, small-scale clinical studies. Depending on whether the compound has been studied or marketed previously, the sponsor may have several options for fulfilling this requirement: Compiling existing nonclinical data from past  in vitro  laboratory or animal studies on the compound Compiling data from previous clinical testing or marketing of the drug Undertaking new preclinical studies designed to provide the evidence necessary to support the safety of administering the compound to humans. Introduction to Pre-Clinical Trials 6

Preclinical Review By FDA (Contd.):

Preclinical Review By FDA (Contd.) At the preclinical stage, the FDA will generally ask, Develop a pharmacological profile of the drug Determine the acute toxicity of the drug in at least two species of animals Conduct short-term toxicity studies ranging from 2 weeks to 3 months, depending on the proposed duration of use of the substance in the proposed clinical studies. Introduction to Pre-Clinical Trials 7

Objectives of Preclinical Trial:

Objectives of Preclinical Trial Objective is to develop adequate data to decide that it is reasonably safe to proceed with human trials of the drug, means, a laboratory test of a new drug or a new medical device, usually done on animal subjects, to see if the treatment really works and if it is safe to test on humans. Introduction to Pre-Clinical Trials 8

Importance of Preclinical Trials:

Importance of Preclinical Trials Introduction to Pre-Clinical Trials 9

Goals Of Preclinical Studies:

Goals Of Preclinical Studies Introduction to Pre-Clinical Trials 10

Types Of Preclinical Trials:

Types Of Preclinical Trials Introduction to Pre-Clinical Trials 11

Types of Trials:

Types of Trials Introduction to Pre-Clinical Trials 12

In Vitro Preclinical Trials:

In Vitro Preclinical Trials Introduction to Pre-Clinical Trials 13

In Vivo Preclinical Trials:

In Vivo Preclinical Trials Introduction to Pre-Clinical Trials 14

In Vivo Preclinical Trials (Contd.):

In Vivo Preclinical Trials (Contd.) Introduction to Pre-Clinical Trials 15

Stages of Preclinical Trials:

Stages of Preclinical Trials Introduction to Pre-Clinical Trials 16

Stages Of Preclinical Development:

Stages Of Preclinical Development Introduction to Pre-Clinical Trials 17

Lead Selection and Optimisation:

Lead Selection and Optimisation Introduction to Pre-Clinical Trials 18

Drug Candidate Confirmation:

Drug Candidate Confirmation Introduction to Pre- Clinical Trials 19

Preclinical Drug Characteristics:

Preclinical Drug Characteristics Introduction to Pre- Clinical Trials 20

Considerations for trials:

Considerations for trials Introduction to Pre-Clinical Trials 21

Reference:

Reference www.fda.gov www.medicinenet.com ICH Guidelines BRITISH JOURNAL OF PHARMACOLOGY The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients; Andrew G Polson  and  Reina N Fuji Introduction to Pre-Clinical Trials 22

Slide 23:

Introduction to Pre-Clinical Trials 23

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