OPEN TRIAL :: In an open trial the researcher knows the full details of the treatment…
PHASE III : STATISTICAL EVALUATION :: Here the results obtained in Phase II at limite…
PLACEBO :: In medical term placebo means dummy medication it is a pharmacologically i…
PHASE II : FIRST IN THE PATIENT STUDY :: Once the initial safety of the therapy has b…
MULTIPLE ASCENDING DOSE STUDIES (MAD) :: They are conducted to better understand the …
PHASE 1 : FIRST IN THE HUMAN STUDY :: Phase 1 trials are the first -stage of testing …
INFORMED CONSENT FORM :: To be ethical they must evolve the Informed Consent Form of …
CLINICAL EVALUATION OF DRUGS CLINICAL TRIALS :: Clinical trials is a name given to a …
AMES TEST (REVERSE MUTATION ASSAY IN SALMONELLA) :: S.typhimurium tester strains such…
GENOTOXICITY :: Genotoxic compounds in the absence of other data is presumed to be tr…
OCULAR TOXICITY STUDIES :: These studies should be carried out in two species one of …
LOCAL TOXICITY :: These studies are required when the new drug is proposed to be used…
GROSS AND MICROSCOPIC PATHOLOGY :: (a) Brain Cerebrum cerebellum Midbrain (b) (Spina…
BIOCHEMICAL PARAMETERS BLOOD :: (a)Glucose (b) Cholesterol (c) Triglycerides (d) H…
LABORATORY PARAMETERS TO BE INCLUDED IN TOXICITY STUDIES :: 1.HAEMATOLOGICAL PARAMETE…
DEVELOPMENTAL TOXICITY (TERATOGENICITY STUDY):; This may be performed in one rodent (…
FEMALE REPRODUCTION AND DEVELOPMENTAL TOXICITY STUDIES :: These studies are to be car…
SPECIALIZED TOXICITY STUDY :: These include fertility study carcinogenicity genotoxic…
LOCAL TOXICITY STUDIES --------------------------------------------------------------…
ANIMAL TOXICITY REQUIREMENTS FOR CLINICAL TRIALS AND MARKETING OF A NEW DRUG :: -----…
SUBACUTE TOXICITY :: In this test three doses of drug are administered for a period o…
SINGLE-DOSE TOXICITY STUDIES :: As per Schedule Y single dose toxicity studies are to…
PRE-CLINICALINON/CLINICAL TOXICITY STUDIES :: Various the safety tests or toxicity te…
TOXICITY STUDIES :: A number of incidents in different parts of the world such as ser…
TOXICITY IS CLASSIFIED :: Toxicity is classified depending on duration of study For e…
CLASSIFICATION OF ADVERSE DRUG REACTIONS :: As such no universal classification system…
TOXICOLOGY PRE-CLINICAL TOXICITY AND CLINICAL TRIALS :: Toxicology is the branch of s…
BIOASSAY OF ACETYLCHOLINE :: Principle :: Potency of the test sample is compared with…
FROG S RECTUS ABDOMINIS MUSCLE PREPARATION :: A frog is pithed and laid on its back o…
BIOASSAY OF d-TUBOCURARINE :: Rabbit Head-drop Method : Principle :: d-Tubocararine h…
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