Section 3 Pharmaceutical Form
Found 6 free book(s)Q8(R2) - ICH
database.ich.orgThe Pharmaceutical Development section should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. This section should include sufficient information in each part to provide an understanding of the development of the drug product and its
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 3 ...
medsafe.govt.nzFor the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated Tablets 12.5 mg tablet: Blue, oval, biconvex film coated tablets, plain on both sides . Dimensions: 8.2mm x 4.4 mm . 25 mg tablet: White to off white, oval shaped, biconvex, film coated tablets with ‘25’ embossing on one side and plain on the other side.
Annex 1 WHO good practices for pharmaceutical quality ...
www.who.intmanufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body (1).
Annex 5 Guidelines for stability testing of pharmaceutical ...
www.paho.orgThe stability of finished pharmaceutical products depends, on the one hand, on environmental factors such as ambient temperature, humidity and light, and, on the other, on product-related factors, e.g. the chemical and physical properties of the active substance and of pharmaceutical excipients, the dosage form and its composition, the
Annex 9 Guidelines on packaging for pharmaceutical …
www.who.intGuidelines on packaging for pharmaceutical products Introductory note 120 Glossary 121 1. Aspects of packaging 125 1.1 General considerations 125 1.2 Functions of packaging 127 1.2.1 Containment 127 1.2.2 Protection 127 1.3 Presentation and information 129 1.3.1 Labels 129 1.3.2 Repacking, relabelling and dispensing 130
CRITERIA FOR DIAGNOSIS AND MANAGEMENT ... - Ministry …
www.health.nsw.gov.auApplications may be referred to the Medical Committee, established under Section 30 of the Poisons and Therapeutic Goods Act, for its advice. Subsequent applications should be made on Form 1 and a full progress report must be attached if requested. 6. REFERRAL TO GENERAL PRACTITIONERS