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Ich Guidelines (Points To Remember)

POINTS TO REMEMBER

 ICH GUIDELINES

4 board categories– QSEM
✅ QUALITY
☑️ SAFETY
✔️ EFFICACY
✅ MULTIDISCIPLINARY

Q1 ➡️ Stability

Q2 ➡️ Analytical Validation

Q3 ➡️ Impurities

Q4 ➡️ Pharmacopoeias

Q5 ➡️ Quality of Biotechnology products

Q6 ➡️ Specifications

Q7 ➡️ Good manufacturing practices (GMP)

Q8 ➡️ Pharmaceutical Development

Q9 ➡️ Quality Risk Management

Q10 ➡️ Pharmaceutical Quality System

Q11 ➡️ Development and Manufacturing of drug Substance

Q12 ➡️ Lifecycle management

Q13 ➡️ Continuous manufacturing of Drug substance and drug product

Q14 ➡️ Analytical procedure development

 SAFETY GUIDELINES

 S1 ➡️ Carcinogenicity Studies

S2  ➡️ Genotoxicity Studies

S3 ➡️ Toxicokinetics and Pharmacokinetics

S4 ➡️ Toxicity Testing

S5 ➡️ Reproductive Toxicology

S6 ➡️ Biotechnology Products

S7 ➡️ Pharmacology Studies

S8 ➡️ Immunotoxicology Studies

S9 ➡️ Nonclinical Evaluation for Anticancer Pharmaceuticals

S10 ➡️ Photosafety Evaluation

S11 ➡️ Nonclinical Safety Testing

EFFICACY GUIDELINES

E1 ➡️ Clinical Safety for Drugs used in Long – Term Treatment

E2 ➡️ Pharmacovigilance

E3 ➡️ Clinical Study Reports

E4 ➡️ Dose – Response Studies

E5 ➡️ Ethnic Factors

E6 ➡️ Good Clinical Practice

E7 ➡️ Clinical Trials in Geriatric Population

E8 ➡️ General Consideration for Clinical Trials

E9 ➡️ Statistical Principles for Clinical Trials

E10 ➡️ Choice of Control Group in Clinical Trials

E11 ➡️ Clinical Trials in Pediatric Population

E12 ➡️ Clinical Evaluation by Therapeutic Category

E13 ➡️ Principles for Clinical Evaluation of New Antihypertensive Drugs

E14 ➡️ Clinical Evaluation of QT

E15 ➡️ Definitions in Pharmacogenetics/ Pharmacogenomics

MULTIDISCIPLINARY

M1 ➡️ MedDRA Terminology

M2 ➡️ *Electronic standards

M3 ➡️ Nonclinical Safety Studies

M4 ➡️ Common Technical Document

M5 ➡️ Data Elements and Standards for Drug Dictionaries

M6 ➡️ Gene Therapy

M7 ➡️ Genotoxic Impurities

M8 ➡️ Electronic Common Technical Document

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